Status:
COMPLETED
Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Relapsed Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VEL...
Eligibility Criteria
Inclusion
- Male or female patient 18 years of age or older
- Pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma. Patients with transformed follicular lymphoma are eligible, provided there has previously been pathologic documentation of follicular lymphoma.
- Documented relapse or progression following prior antineoplastic therapy
- At least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and greater than 1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
- No clinically significant evidence of active 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. Patients with prostate cancer who were treated with definitive radiotherapy who have a serum prostate-specific antigen \<1 ng/mL are not excluded. Patients are 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.
- Received any of the following treatments or procedures outside of the specified timeframes:
- Prior treatment with VELCADE
- Prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2, if assigned to Arm A (VELCADE-R-CAP)
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00715208
Start Date
September 1 2008
End Date
March 1 2011
Last Update
April 29 2013
Active Locations (43)
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1
Northwest Alabama Center, PC
Muscle Shoals, Alabama, United States, 35661
2
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
3
Pacific Coast Hematology Oncology Medical Group
Fountain Valley, California, United States, 92708
4
Loma Linda U Cancer Center
Loma Linda, California, United States, 92354