A Phase III, Randomized, Double-Blind Study of Galiximab in Combination with Rituximab Compared with Rituximab in Combination with Placebo for the Treatment of Subjects with Relapsed or Refractory, Follicular Non Hodgkin’s Lymphoma

• Conditions: Relapsed or Refractory, Follicular Non-Hodgkin’s Lymphoma; MedDRA version: 8.1Level: LLTClassification code 10029627Term: Non-Hodgkin's lymphoma unspecified histology intermediate grade refractory

• Registration Number: EUCTR2005-003836-22-LT
• Lead Sponsor: Biogen Idec Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 742

Inclusion Criteria

To be considered for registration and randomization into this study, subjects must satisfy all of the following criteria:
1. Must give written informed consent and any authorizations as required by local law
2. Aged =18 years old at the time of informed consent
3. Histologically confirmed follicular Grade 1-3a NHL. If slides and/or tissue blocks
from the most recent lymph biopsy are not available for Central Pathology Review, a
repeat lymph node biopsy is required prior to enrollment. If there is any clinical
evidence suggesting transformation (e.g. elevated LDH >2× upper limit of normal),
a biopsy is required within 6 months prior to enrollment. Subjects with evidence of
histologic transformation on a repeat biopsy are excluded from this study.
4. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment as determined by one of the following:
- Documented disease progression by CT scan using the International Workshop Response Criteria (IWRC) as described in protocol Appendix C
- The presence of B symptoms
- Bulky disease (at least 1 lesion >5 cm)
- Laboratory abnormalities (cytopenias)
- Presence of masses which are causing ongoing clinical symptoms
5. Bidimensionally measurable disease with at least 1 lesion =2.0 cm in a single dimension
6. Hematologic, hepatic, and renal function parameters satisfying the following:
- Bilirubin =2.0 mg/dL
- AST (SGOT) =2 x upper limit of normal (ULN) and ALT (SGPT) = 2 x ULN
- Serum creatinine = 2.0 mg/dL
- Hemoglobin = 8.0 g/dL
- Absolute neutrophil count = 1500 cells/mm3
- Platelet count = 75,000 plts/mm3
7. WHO Performance Status = 2
8. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs
9. Expected survival of = 3 months
10. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unless otherwise specified, candidates will be excluded from study entry if any of the
following exclusion criteria exist at the time of randomization:
1. Follicular lymphoma Grade 3b
2. Previous exposure to galiximab or any anti-CD80 antibody
3. Known hypersensitivity to murine proteins
4. Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months)
5. Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to
Study Day 1 (6 weeks if nitrosourea or mitomycin-C)
6. Prior lymphoma vaccine therapy within 12 months prior to Study Day 1
7. Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1
8. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1
9. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1
10. Prior allogeneic transplant
11. Transfusion-dependent subjects
12. Known history of hepatitis or hepatic disease. (Although testing for hepatitis B is not mandatory, this should be considered for all subjects considered at high risk for hepatitis B infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B exposure should be excluded unless the serological findings are clearly due to vaccination.)
13. Presence of chronic lymphocytic leukemia (CLL), marginal zone lymphoma,
mucosa-associated lymphoid tissue (MALT)
14. Presence of central nervous system (CNS) lymphoma
15. Known history of HIV infection or AIDS
16. Prior diagnosis of aggressive NHL or mantle-cell lymphoma
17. Histologic transformation
18. Presence of pleural or peritoneal effusion with positive cytology for lymphoma
19. Another primary malignancy requiring active treatment (except hormonal therapy)
20. Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor
21. New York Heart Association Class III or IV cardiac disease or myocardial infarction
within 6 months prior to Study Day 1
22. Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
23. History of alcoholism or substance abuse within the 2 years prior to Study Day 1
24. Pregnant or currently breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the clinical benefit of galiximab in combination with rituximab with that of rituximab monotherapy for the treatment of subjects with relapsed or refractory, follicular NHL.<br><br>;Secondary Objective: · To further characterize the safety profile of galiximab in combination with rituximab.<br>· To further characterize the pharmacokinetics (PK) of 4 infusions of galiximab in combination with rituximab.<br><br>;Primary end point(s): The primary study endpoint is Progression-Free Survival (PFS).