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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01039376




Trial ID
NCT01039376
Ethics application status
Date submitted
23/12/2009
Date registered
24/12/2009
Date last updated
3/07/2018

Titles & IDs
Public title
Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy
Scientific title
A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy
Secondary ID [1] 0 0
112517
Universal Trial Number (UTN)
Trial acronym
PROLONG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukaemia, Lymphocytic, Chronic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ofatumumab
Other interventions - Observation

Experimental: ARM A: Ofatumumab - Ofatumumab Treatment: 300 mg IV Week 1 followed by 1000 mg IV Week 2 1000 mg IV (a dose every 8 weeks for up to 2 years following the first 1000 mg dose)

Other: ARM B: Observation and assessments as per Arm A - Disease status assessments to determine subject response or progression will be performed approximately every 8 weeks for up to 2 years for both arms according to IWCLL criteria


Other interventions: Ofatumumab
Ofatumumab for maintenance therapy as IV infusions every 8 weeks . The first dose will be 300 mg followed 1 week later by 1000 mg and 1000 mg every 8 weeks thereafter for up to 2 years).

Other interventions: Observation
Observation/Safety Evaluation

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival, as Assessed by the Investigator - Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.
Timepoint [1] 0 0
From randomization until progression or death (up to 84 months)
Primary outcome [2] 0 0
Progression-free Survival, as Assessed by the Independent Review Committee (IRC) - Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.
Timepoint [2] 0 0
From randomization until progression or death (up to 84 months)
Secondary outcome [1] 0 0
Overall Survival - Overall survival is defined as time from randomization to date of death.
Timepoint [1] 0 0
From randomization until death (up to 84 months)
Secondary outcome [2] 0 0
Number of Participants With Improvement in Response From Baseline - Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.
Timepoint [2] 0 0
From Baseline until the end of the study (up to 24 months)
Secondary outcome [3] 0 0
Time to Next Therapy - Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.
Timepoint [3] 0 0
From randomization until the end of the study (up to 84 months)
Secondary outcome [4] 0 0
Progression-free Survival After Next-line Therapy - Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event.
Timepoint [4] 0 0
From randomization until progression or death (up to 84 months)
Secondary outcome [5] 0 0
Time to Progression After Next-line Therapy - Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event.
Timepoint [5] 0 0
From randomization until progression or death (up to 84 months)
Secondary outcome [6] 0 0
Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16) - The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) - and single-item scales (social activities [Social Problems (SP) Scale] and future health worries [Future Health (FH) Scale]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA).
Timepoint [6] 0 0
From randomization until the end of the study (up to 84 months)
Secondary outcome [7] 0 0
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score - The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from "poor" (worse quality of life) to "excellent" (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA.
Timepoint [7] 0 0
From randomization until the end of the study (up to 84 months)
Secondary outcome [8] 0 0
Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale - EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life.
Timepoint [8] 0 0
From randomization until the end of the study (up to 84 months)
Secondary outcome [9] 0 0
Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points - Improvement is defined as a decrease from Baseline by at least one step on the ECOG performance status scale (improvement categorized as yes or no). The proportion of participants with improvement was compared between treatment groups with the Cochran-Mantel-Haenszel test adjusting for stratification factors (response at entry, number of prior treatments and type of prior treatment). Improvement in ECOG performance status was measured at the available time points that have data: Cycle (C) 1 Week (W) 2/Month (M) 1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M Follow-up (FU), 6M FU, 9M FU, 12M FU, 15M FU, 18M FU, 21M FU and Withdrawal (WDL).
Timepoint [9] 0 0
From randomization until the end of the study (up to 84 months)
Secondary outcome [10] 0 0
Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points - Par. with the indicated constitutional or B-symptoms (night sweats [without signs of infection]; unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of > 38 degrees celcius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue) were presented. The proportion of par. with no night sweats, no weight loss, no fever and no extreme fatigue were summarized and compared to the proportion of par. with >= 1 of the following: night sweats, weight loss, fever or extreme fatigue. The proportions were compared between treatment groups with the Cochran-Mantel-Haenszel test adjusting for stratification factors (response at entry, number of prior treatments and type of prior treatment). B-symptoms were assessed at the following time points: Screening, C1 W1/M1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M, 6M, 9M, 12M, 15M, 18M, 21M FU and WDL.
Timepoint [10] 0 0
From Screening until the end of the study (up to 84 months)
Secondary outcome [11] 0 0
Number of Participants With Grade 3 and Above Adverse Event of Infection - Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).
Timepoint [11] 0 0
From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 84 months)
Secondary outcome [12] 0 0
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) - An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Timepoint [12] 0 0
From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 24 months for non-serious AEs and 84 months for SAEs)
Secondary outcome [13] 0 0
Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points - Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Number of participants who reported myelosuppression (anemia [low hemoglobin count], neutropenia [low neutrophil count], and thrombocytopenia [low platelet count]) are presented. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death). Assessment was at the following time points: Screening, C1 W1/M1, C1 W2/M1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C5 unscheduled, C6 W41/M11, C6 unscheduled, C7 W49/M13, C8 W57/M15, C8 unscheduled, C9 W65/M17, C10 W73/M19, C11 W81/M21,C11 unscheduled, C12 W89/M23, C13 W97/M25, 3M, 6M, 9M, 12M FU and WDL.
Timepoint [13] 0 0
From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 24 months)
Secondary outcome [14] 0 0
Number of Participants Who Received at Least One Transfusion During the Study - Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.
Timepoint [14] 0 0
From randomization until the end of the study (up to 24 months)
Secondary outcome [15] 0 0
Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA) - AIHA is a disease where the body's immune system fails to recognize red blood cells as "self" and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented.
Timepoint [15] 0 0
From randomization until the end of the study (up to 24 months)
Secondary outcome [16] 0 0
Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result - All serum samples for analysis of HAHA were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA positive and further evaluated in the titration test to obtain a titer of HAHA. A confirmed positive result at any time point means the participant is positive for HAHA.Results are reported as the number of participants positive for HAHA.
Timepoint [16] 0 0
Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)
Secondary outcome [17] 0 0
Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points - Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-baseline value minus the Baseline value. Immunoglobulins were measured at the following time points: Baseline (BL) and Cycle (C) 2 Week (W) 9/Month (M) 3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M Follow-up (FU), 6M FU, 9M FU, 12M FU, 15M FU, 18M FU, 21M FU and Withdrawal (WDL) were presented.
Timepoint [17] 0 0
Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 24 months)
Secondary outcome [18] 0 0
Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit - MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed complete remission. Number of participants who were positive and negative for minimal residual disease (MRD) at any visit is presented.
Timepoint [18] 0 0
From randomization until the end of the study (up to 84 months)
Secondary outcome [19] 0 0
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points - CD5+CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Timepoint [19] 0 0
Baseline and every two months from Month 3 until Month 25 and at every follow-up visit (up to 84 months)
Secondary outcome [20] 0 0
Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers - Blood samples were collected for the assessment of the following prognostic markers at Baseline (BL) and upon relapse: immunoglobulin heavy chain variable region (IgVH) mutational status; VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]) including 6q-, 11q-, +12q, 17p-, 13q- deletions; beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH) at BL, IgVH mutational status at BL, beta 2 microglobulin at BL, BL CD20 and BL complement level. For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=CY G.
Timepoint [20] 0 0
From Baseline until the end of the study (up to 84 months)
Secondary outcome [21] 0 0
Cmax and Ctrough of Ofatumumab - Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected at pre-dose and 0.5 hours after the end of the infusion at treatment on Month 1 Week 1 (Day 1), Month 1 Week 2 (Day 8), and at every second infusion.
Timepoint [21] 0 0
Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
Secondary outcome [22] 0 0
Total Plasma Clearance (CL) of Ofatumumab - Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.
Timepoint [22] 0 0
Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
Secondary outcome [23] 0 0
AUC(0-tau) of Ofatumumab - Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of the drug exposure over time.
Timepoint [23] 0 0
Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)
Secondary outcome [24] 0 0
Vss of Ofatumumab - Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of a drug between plasma and the rest of the body at steady state. Data from all time points collected were used to calculate one Vss value for each individual.
Timepoint [24] 0 0
Day 1 Month 1 ( Cycle 1) through Month 25 ( Cycle 13)
Secondary outcome [25] 0 0
Plasma Half-life (t1/2) of Ofatumumab - The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.
Timepoint [25] 0 0
Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)

Eligibility
Key inclusion criteria
- Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG
guidelines (Hallek, 2008)

- At least PR according to the revised 2008 NCI-WG CLL criteria, within 3 months of the
response assessment after the last dose of 2nd/3rd line treatment

- The anti-leukemic treatment before study entry should have been at least 3 months or 3
cycles

- ECOG Performance Status of 0-2

- Signed written informed consent prior to performing any study-specific procedures
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known primary or secondary fludarabine-refractory subjects, defined as treatment
failure (failure to achieve a CR or PR) or disease progression within 6 months

- Prior maintenance therapy

- Known transformation of CLL (eg.Richter's transformation), prolymphocytic leukemia
(PLL), or CNS involvement of CLL

- Active Autoimmune hemolytic anemia (AIHA) requiring treatment except if in the opinion
of the investigator and medical monitor it is thought not to affect the subject's
safety, the conduct of the study or the interpretation of the data

- Previous autologous or allogeneic stem cell transplantation

- Chronic or current active infectious disease requiring systemic antibiotics,
antifungal, or antiviral treatment such as, but not limited to chronic renal
infection, chronic chest infection with bronchiectasis, tuberculosis and active
Hepatitis B or C

- Other past or current malignancy (with the exception of basal cell carcinoma or the
skin or in situ carcinoma of the cervix or breasts) unless the tumor was successfully
treated with curative intent at least 2 years prior to trial entry except if in the
opinion of the investigator and medical monitor it is thought not to affect the
subject's safety, the conduct of the study or the interpretation of the data

- Clinically significant cardiac disease, including unstable angina, acute myocardial
infarction within 6 months prior to screening, congestive heart failure, and
arrhythmia requiring therapy, with the exception of exta systoles or minor conduction
abnormalities except if in the opinion of the investigator and medical monitor it is
thought not to affect the subject's safety, the conduct of the study or the
interpretation of the data

- History of significant cerebrovascular disease or event with symptoms or sequelae

- Significant concurrent, uncontrolled medical condition that in the opinion of the
investigator or GSK medical monitor contraindicates participation in this study

- Other anti-leukemic use of medications including glucocorticoids

- Known HIV positive

- Screening laboratory values: platelets <50 x 109/L, neutrophils<1.0 x 109/L,
Creatinine > 1.5 X upper normal limit (unless normal creatinine clearance), total
bilirubin >1.5 X upper normal limit, ALT >2.5 X upper normal limit (unless due to
liver involvement of CLL), alkaline phosphase > 2.5 X upper normal limit

- Known or suspected hypersensitivity to ofatumumab that in the opinion of the
investigator or medical monitor contraindicates study participation

- Subjects who have received treatment with any non-marketed drug substance or
experimental therapy within 5-terminal half-lives or 4 weeks whichever is longer prior
to first dose of study medication or currently participating in any other
interventional clinical study Note: Participation in any other interventional clinical
study after disease progression during post PD follow-up is permitted

- Lactating women, women with a positive pregnancy test at Visit 1 or women (of
childbearing potential) as well as men with partners of childbearing potential, who
are not willing to use adequate contraception from study start through one year
following last ofatumumab dose. Adequate contraception is defined as abstinence, oral
hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring,
percutaneous contraceptive patches, intrauterine device, and male partner
sterilization if male partner is sole partner for that subject. For females in the
USA, the use of a double barrier method is also considered adequate (condom or
occlusive cap plus spermicidal agent).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [2] 0 0
Novartis Investigative Site - Randwick
Recruitment hospital [3] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [4] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [5] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autonoma de Buenos Aires
Country [28] 0 0
Belgium
State/province [28] 0 0
Antwerpen
Country [29] 0 0
Belgium
State/province [29] 0 0
Brugge
Country [30] 0 0
Belgium
State/province [30] 0 0
Brussels
Country [31] 0 0
Belgium
State/province [31] 0 0
Gent
Country [32] 0 0
Belgium
State/province [32] 0 0
Hasselt
Country [33] 0 0
Belgium
State/province [33] 0 0
Roeselare
Country [34] 0 0
Belgium
State/province [34] 0 0
Wilrijk
Country [35] 0 0
Brazil
State/province [35] 0 0
Bahía
Country [36] 0 0
Brazil
State/province [36] 0 0
Goiás
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio Grande Do Sul
Country [38] 0 0
Brazil
State/province [38] 0 0
São Paulo
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Canada
State/province [42] 0 0
Saskatchewan
Country [43] 0 0
Czechia
State/province [43] 0 0
Brno
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Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if maintenance therapy with ofatumumab will prolong
remission in patients with CLL who have responded to second or third line treatment. This
study will also evaluate the safety of ofatumumab maintenance compared to observation (the
current standard of care). This study was co-developed with the HOVON and NORDIC CLL group
and will be conducted as a collaborative effort with GSK.
Trial website
https://clinicaltrials.gov/show/NCT01039376
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries