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

NCT00636792 | Completed Phase 2 Results

• 1 other identifier: C05011
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Response

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

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

Secondary Outcomes (1)

• Number of Participants With Overall Response (Complete and Partial Response)

  12 weeks after the last subject completes their end of treatment visit

Study Arms (1)

1

EXPERIMENTAL

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.

Drug: VELCADE; Drug: Bendamustine; Drug: Rituximab

Interventions

VELCADE 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.

1

Bendamustine DRUG

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

1

Rituximab 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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (2)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

MidDakota Clinic - Cancer Treatment and Research Center

Bismarck, North Dakota, 58501, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Bortezomib; Bendamustine Hydrochloride; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Butyrates; Acids, Acyclic; Carboxylic Acids; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Carol Satler
• Organization: Millennium Pharmaceutical Inc

(617) 551-3729

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 14, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 13, 2012
• Results First Posted: June 22, 2011

Record last verified: 2012-01

Locations

US (2)