Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02809053




Registration number
NCT02809053
Ethics application status
Date submitted
20/06/2016
Date registered
22/06/2016
Date last updated
8/10/2020

Titles & IDs
Public title
A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Scientific title
A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Secondary ID [1] 0 0
AGB002
Universal Trial Number (UTN)
Trial acronym
RAMO-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Follicular 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
Other interventions - SAIT101
Other interventions - MabThera®

Experimental: SAIT101 -

Active Comparator: MabThera® -


Other interventions: SAIT101
Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22

Other interventions: MabThera®
Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) at Week 28
Timepoint [1] 0 0
Baseline (Day 0) to Week 28.
Secondary outcome [1] 0 0
Overall Response Rate (ORR) at Week 12
Timepoint [1] 0 0
Baseline (Day 0) to Week 12
Secondary outcome [2] 0 0
Complete Response (CR) at Weeks 12 and 28
Timepoint [2] 0 0
Baseline (Day 0) to Week 12 and Week 28.
Secondary outcome [3] 0 0
Partial Response (PR) at Weeks 12 and 28
Timepoint [3] 0 0
Baseline (Day 0) to Week 12 and Week 28.
Secondary outcome [4] 0 0
Stable Disease (SD) at Weeks 12 and 28
Timepoint [4] 0 0
Baseline (Day 0) to Week 12 and Week 28.
Secondary outcome [5] 0 0
Progressive Disease (PD) at 12 and 28 Weeks
Timepoint [5] 0 0
Baseline (Week 0)to Week 12 and Week 28.
Secondary outcome [6] 0 0
Time to Event (TTE)
Timepoint [6] 0 0
Baseline (Day 0) to time of event or up to a maximum of 32 weeks, whichever is sooner

Eligibility
Key inclusion criteria
1. Patients with histologically-confirmed Low Tumor Burden Follicular Lymphoma, without B
symptoms, Ann Arbor stage II to Non-Hodgkin's Lymphoma (NHL) (CD20+ Follicular
Lymphoma of Grades 1, 2, or 3a)

2. Low tumor burden according to The Groupe d'Etude des Lymphomes Folliculaires (GELF)
criteria defined as:

- Normal serum lactate dehydrogenase (LDH)

- No mass =7 cm.

- Less than 3 nodal sites, each with diameter >3 cm

- No systemic or B symptoms (fever >38°C for 3 consecutive days; recurrent,
drenching night sweats; unintentional weight loss exceeding 10% body weight in
the last 6 months.

- No splenomegaly =16 cm by CT scan.

- No risk of vital organ compression.

- No pleural or peritoneal serous effusion.

- No leukemic phase >5,000/µL circulating tumor cells.

- No cytopenias (defined as platelets <100,000/mm3, hemoglobin <10 g/dL, or
absolute neutrophil count <1,500/mm3).

3. Patients not previously treated for their FL, including any previous treatment for FL
under clinical trials except localized radiation therapy for previous limited stage
disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous treatment with any chemotherapy and/or rituximab or other monoclonal
antibody.

2. Prior radiotherapy completed <28 days before study enrollment.

3. Anticipated need for concomitant administration of any other experimental drug, or a
concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy
during study participation.

4. Concomitant disease which requires continuous therapy with corticosteroids at doses
equivalent to prednisolone >20 mg/day.

5. Transformation to high-grade lymphoma secondary to previously untreated low-grade
lymphoma.

6. Prior or concomitant malignancies within 5 years prior to screening, with the
exceptions of non-melanoma skin cancer, adequately treated carcinoma in situ of the
cervix, adequately treated breast cancer in situ, and localized prostate cancer stage
T1c, provided that the patient underwent curative treatment and remains relapse free.

7. Patients with a body surface area >3.0 m2.

8. Major surgery (excluding lymph node biopsy) within 28 days prior to randomization.

9. Primary or secondary immunodeficiency (history of, or currently active), including
known history of human immunodeficiency virus (HIV) infection or positive test at
screening.

10. Acute, severe infection (e.g., sepsis and opportunistic infections), or active,
chronic or persistent infection that might worsen with immunosuppressive treatment
(e.g., herpes zoster).

11. Positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core
antibody (HBcAb) or hepatitis C serology.

12. Confirmed current active tuberculosis (TB)

13. Central nervous system (CNS) or meningeal involvement, or cord compression by the
lymphoma; history of CNS lymphoma

14. History of a severe allergic reaction or anaphylactic reaction to a biological agent
or history of hypersensitivity to any component of the trial drug (e.g.,
hypersensitivity or allergy to murine products).

15. Patients who have significant cardiac disease, including but not limited to history of
congestive heart failure (New York Heart Association Class III/IV; see Appendix 7),
unstable angina, or uncontrolled cardiac arrhythmia.

16. Uncontrolled or severe hypertension, or cerebrovascular disease.

17. Serious underlying medical conditions that, per the Investigator's discretion, could
impair the ability of the patient to participate in the trial

18. Any other co-existing medical or psychological condition(s) that will preclude
participation in the study or compromise ability to give informed consent and/or
comply with study procedures.

19. Treatment with any investigational medicinal product (IMP) within 4 weeks prior to
initiation of 1st infusion of study drug, or treatment with a drug that has not
received regulatory approval for any indication within 4 weeks or a minimum of 5
half-lives, whichever is longer, of the 1st infusion of study drug.

20. Receipt of a live/attenuated vaccine within 6 weeks prior to the screening visit.

21. Females who are pregnant, breastfeeding, or planning a pregnancy during the treatment
period or within 12 months after the last infusion of study drug.

22. Patients who are investigational site staff members directly involved in the conduct
of the trial, and their family members, site staff members otherwise supervised by the
investigator, or patients who are Archigen employees directly involved in the conduct
of the trial.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
18/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2020
Sample size
Target
Accrual to date
Final
315
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
Research Site - Canberra
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Chile
State/province [2] 0 0
Araucania
Country [3] 0 0
Czechia
State/province [3] 0 0
Hradec Kralove
Country [4] 0 0
Czechia
State/province [4] 0 0
Praha
Country [5] 0 0
France
State/province [5] 0 0
Gironde
Country [6] 0 0
France
State/province [6] 0 0
Vienne
Country [7] 0 0
Germany
State/province [7] 0 0
Hamburg
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
Italy
State/province [9] 0 0
Foggia
Country [10] 0 0
Italy
State/province [10] 0 0
Terni
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Busan
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Mexico
State/province [13] 0 0
Distrito Federal
Country [14] 0 0
South Africa
State/province [14] 0 0
Gauteng
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Cádiz
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Turkey
State/province [18] 0 0
Ankara
Country [19] 0 0
Turkey
State/province [19] 0 0
Istanbul
Country [20] 0 0
Turkey
State/province [20] 0 0
Mersin
Country [21] 0 0
Turkey
State/province [21] 0 0
Samsun
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Norfolk

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Archigen Biotech Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the
statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as
a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden
Follicular Lymphoma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02809053
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02809053