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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00389818




Registration number
NCT00389818
Ethics application status
Date submitted
18/10/2006
Date registered
19/10/2006
Date last updated
6/06/2018

Titles & IDs
Public title
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma
Scientific title
A Phase II Trial of Doxil, Rituximab, Cyclophosphamide, Vincristine, and Prednisone (DR-COP) in Patients With Newly Diagnosed AIDS-Associated B-Cell Non-Hodgkin's Lymphoma
Secondary ID [1] 0 0
U01CA070019
Secondary ID [2] 0 0
AMC-047
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - filgrastim
Treatment: Other - pegfilgrastim
Treatment: Other - rituximab
Treatment: Other - sargramostim
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - pegylated liposomal doxorubicin hydrochloride
Treatment: Drugs - prednisone
Treatment: Drugs - vincristine sulfate
Other interventions - immunohistochemistry staining method
Other interventions - laboratory biomarker analysis

Experimental: DR-COP - Single arm interventional study: all subjects receive DR-COP regimen.


Treatment: Other: filgrastim
Supportive therapy: GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

Treatment: Other: pegfilgrastim
GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

Treatment: Other: rituximab
375 mg/m2 IV Day 1 of each cycle

Treatment: Other: sargramostim
GF therapy with G-CSF, GM-CSF, or pegfilgrastim will be used in all patients, beginning on Day 3 of each cycle, until post nadir of blood counts from each chemotherapy cycle.

Treatment: Drugs: cyclophosphamide
750 mg/m2 IV Day 1 of each cycle

Treatment: Drugs: pegylated liposomal doxorubicin hydrochloride
40 mg/m2 IV Day 1 of each cycle

Treatment: Drugs: prednisone
100 mg PO Days 1-5 of each cycle

Treatment: Drugs: vincristine sulfate
1.4 mg/m2 IV Day 1 (2.0 mg maximum) of each cycle

Other interventions: immunohistochemistry staining method
tissue specimen collected at baseline

Other interventions: laboratory biomarker analysis
tissue specimen collected at baseline
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .
Timepoint [1] 0 0
After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Primary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Primary outcome [3] 0 0
Median Survival Time
Timepoint [3] 0 0
After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Primary outcome [4] 0 0
Rate of Bacterial, Fungal, and Opportunistic Infections
Timepoint [4] 0 0
After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Secondary outcome [1] 0 0
Relationship Between MDR-1 Expression and Response to Treatment
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue
Timepoint [2] 0 0
Baseline, after cycles 4 and 6, 1 month after treatment discontinuation
Secondary outcome [3] 0 0
Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time
Timepoint [3] 0 0
After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Secondary outcome [4] 0 0
Mortality and Cause of Death
Timepoint [4] 0 0
At any time through the third year after treatment discontinuation
Secondary outcome [5] 0 0
Event-free Survival at 1 Year
Timepoint [5] 0 0
1 year post-treatment

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed AIDS-related B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:

* Grade III follicular large cell lymphoma
* Diffuse large B-cell lymphoma
* Immunoblastic lymphoma
* Plasmablastic lymphoma
* Primary effusion lymphoma
* Previously untreated disease
* Any stage disease
* CD20 positive disease
* Must have documented HIV infection

* Documentation may be by serology (enzyme-linked immunosorbent assay, western blot), culture, or quantitative polymerase chain reaction or branched DNA assays
* Prior documentation of HIV seropositivity allowed
* Measurable or nonmeasurable disease
* Currently receiving effective highly active anti-retroviral therapy
* No primary CNS lymphoma, including parenchymal brain or spinal cord lymphoma
* No presence of leptomeningeal disease (positive cerebrospinal fluid for lymphoma) or presence of metastatic disease to brain, in terms of any mass lesion

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100%
* Life expectancy = 2 months
* Absolute granulocyte (neutrophil) count = 1,000/mm³ (unless secondary to lymphomatous involvement of bone marrow)
* Platelet count = 75,000/mm³ (unless secondary to lymphomatous involvement of bone marrow or due to HIV-related thrombocytopenia)
* Bilirubin = 2.0 mg/dL (unless elevated secondary to lymphomatous involvement of liver or biliary system or due to other HIV medications [e.g., indinavir, tenofavir, or atazanavir])
* SGOT = 5 times upper limit of normal
* Creatinine = 2.0 mg/dL OR creatinine clearance = 60 mL/min (unless secondary to renal involvement by lymphoma)
* LVEF normal by MUGA or echocardiogram
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma that does not require systemic therapy
* No serious, ongoing, nonmalignant disease or infection that would preclude study compliance, in the opinion of the investigator
* No history of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for = 2 days
* No acute, intercurrent infection that would preclude study treatment

* Patients with Mycobacterium avium are eligible
* No cardiovascular problems, including any of the following:

* Myocardial infarction within the past 6 months
* New York Heart Association class II-IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* Clinically significant pericardial disease
* ECG evidence of acute ischemic or active conduction system abnormalities.
* No shortness of breath at rest
* Arterial PO_2 = 70 or pulse oximeter-derived O_2 saturation = 94% on room air (unless due to lymphomatous involvement of the lungs)
* Able to comply with study and provide adequate informed consent

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 4 weeks since prior major surgery (except diagnostic surgery)
* At least 12 months since prior rituximab unless it was only given for indications other than the treatment of aggressive lymphoma
* No prior cytotoxic chemotherapy or radiotherapy for this lymphoma

* Concurrent radiotherapy, with or without steroids, for emergency conditions secondary to lymphoma (i.e., CNS tumor or cord compression) allowed
* No zidovudine or zidovudine-containing regimen (including Combivir® or Trizivir®) during and for 2 months after completion of chemotherapy
* Concurrent erythropoietin or filgrastim (G-CSF) allowed

* Growth factor therapy must be discontinued = 24 hours prior to study entry
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 2
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
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Other
Name
AIDS Malignancy Consortium
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
The Emmes Company, LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexandra M. Levine, MD
Address 0 0
City of Hope Comprehensive Cancer Center
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?



Results publications and other study-related documents

TypeCitations or Other Details
Journal Levine AM, Noy A, Lee JY, Tam W, Ramos JC, Henry D... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00389818