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A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma.

Phase 2
18 Years
Not Enrolling
Relapsed Follicular Lymphoma

Thank you

Trial Information

A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma.

Inclusion Criteria:

- Male or female patient 18 years of age or older

- Pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma.
Patients with transformed follicular lymphoma are eligible, provided there has
previously been pathologic documentation of follicular lymphoma.

- Documented relapse or progression following prior antineoplastic therapy

- At least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and
greater than 1.0 cm in the short axis that has not been previously irradiated, or has
grown since previous irradiation

- No clinically significant evidence of active 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. Patients
with prostate cancer who were treated with definitive radiotherapy who have a serum
prostate-specific antigen <1 ng/mL are not excluded. Patients are 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.

- Received any of the following treatments or procedures outside of the specified

- Prior treatment with VELCADE

- Prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2,
if assigned to Arm A (VELCADE-R-CAP)

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Complete Response (CR)

Outcome Description:

Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.

Outcome Time Frame:

30 weeks

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:

September 2008

Completion Date:

March 2011

Related Keywords:

  • Relapsed Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular



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