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

NCT ID: NCT00636792

Last Updated: 2012-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-05-31

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.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VELCADE

Intervention Type: DRUG

VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle.

Bendamustine

Intervention Type: DRUG

Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle

Rituximab

Intervention Type: DRUG

Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5

Interventions

VELCADE

VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle.

Intervention Type: DRUG

Bendamustine

Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle

Intervention Type: DRUG

Rituximab

Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

MidDakota Clinic - Cancer Treatment and Research Center

Bismarck, North Dakota, United States

Countries

United States

Other Identifiers

C05011

Identifier Type: -

Identifier Source: org_study_id