Phase 2
N=55
Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma
Relapsed Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00715208 ↗Enrolled (actual)
55
Serious AEs
25.5%
Results posted
Apr 2013
Primary outcome: Primary: Number of Patients With Complete Response (CR) — 1; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Drug); cyclophosphamide (Drug); doxorubicin (Drug); VELCADE (Drug); prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Complete Response (CR) |
1; 13 | — |
| SECONDARY Number of Participants With Overall Response (OR) |
6; 37 | — |
| SECONDARY Percentage of Participants With Progression-free Survival (PFS) at 1 Year |
67; 63 | — |
| SECONDARY Duration of Response |
21.9 | — |
| SECONDARY Number of Patients Who Experienced at Least One Serious Adverse Event |
2; 12 | — |
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 VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00715208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.