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

Follicular Lymphoma Clinical Trial

— VERTICAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636792
• Other study ID #: C05011
• Status: Completed
• Phase: Phase 2
• First received: March 11, 2008
• Last updated: January 11, 2012
• Start date: February 2008
• Est. completion date: May 2010

Study information

• Verified date: January 2012
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

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

Locations

Country	Name	City	State
United States	MidDakota Clinic - Cancer Treatment and Research Center	Bismarck	North Dakota
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Number of Participants With Overall Response (Complete and Partial Response)	Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.	12 weeks after the last subject completes their end of treatment visit	Yes