Status:
COMPLETED
A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory folli...
Eligibility Criteria
Inclusion
- Male or female subject 18 years of age or older
- Pathological diagnosis of follicular lymphoma (any grade)
- Documented relapse or progression following prior antineoplastic therapy
- Have received 4 or more prior doses of rituximab
- At least 1 measurable tumor mass (\>1.5 cm in the long axis and \>1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
- No clinically significant central nervous system lymphoma
- Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group Oncology Group \[ECOG\] status ≤2
Exclusion
- Diagnosed or treated for a malignancy other than non-Hodgkin's lymphoma (NHL) within 2 years of first dose, or who were previously diagnosed with a malignancy other than NHL and have any radiographic or biochemical marker evidence of malignancy. Subjects with prostate cancer who were treated with definitive radiotherapy and have a serum prostate-specific antigen (PSA) \<1 ng/mL are not excluded. Subjects are also not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.
- Prior treatment with VELCADE® or bendamustine
- Antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before Day 1 of Cycle 1
- Nitrosoureas within 6 weeks before Day 1 of Cycle 1
- Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1
- Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or prior allogeneic stem cell transplant at any time
- Major surgery within 2 weeks before Day 1 of Cycle 1
- Platelet transfusion within 7 days of Day 1 of Cycle 1 (applies to subjects enrolled in the dose escalation phase only. This does not apply to subjects enrolled in phase 2 of the study).
- Ongoing therapy with corticosteroids. Prednisone ≤15 mg per day or its equivalent is allowed.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00636792
Start Date
February 1 2008
End Date
May 1 2010
Last Update
January 13 2012
Active Locations (2)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20057
2
MidDakota Clinic - Cancer Treatment and Research Center
Bismarck, North Dakota, United States, 58501