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

Phase 2
18 Years
Not Enrolling
Follicular Lymphoma

Thank you

Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Complete Response

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

May 2010

Related Keywords:

  • Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular



Georgetown University Medical Center Washington, District of Columbia  20007
MidDakota Clinic - Cancer Treatment and Research Center Bismarck, North Dakota  58501