A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma

Millennium Pharmaceuticals, Inc.2 sites in 1 country73 target enrollmentFebruary 2008

Overview

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 follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

May 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Millennium Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 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. 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.

Arms & Interventions

1

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 follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Intervention: VELCADE

1

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 follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Intervention: Bendamustine

1

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 follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.

Intervention: Rituximab

Outcomes

Primary Outcomes

Number of Participants With Complete Response

Time Frame: 12 weeks after the last subject completes their end of treatment visit.

Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.