Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma

Completed · Phase 2

Conditions studied: Relapsed Follicular Lymphoma

In brief

This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.

Key facts

Study ID

NCT00715208

Run by

Millennium Pharmaceuticals, Inc.

People needed

55

Starts

2008-09-01

Expected to finish

2011-03-01

Last updated by the study team

2013-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

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. 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 timeframes:
• 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

Where it is running

• Northwest Alabama Center, PC — Muscle Shoals, Alabama, United States
• Providence Saint Joseph Medical Center — Burbank, California, United States
• Pacific Coast Hematology Oncology Medical Group — Fountain Valley, California, United States
• Loma Linda U Cancer Center — Loma Linda, California, United States
• Desert Hematology Medical Group, Inc. — Rancho Mirage, California, United States
• Cancer Center of Central Connecticut — Southington, Connecticut, United States
• Ocala Cancer Institute — Ocala, Florida, United States
• Northwest Georgia Oncology Centers, PC — Marietta, Georgia, United States
• Southern Illinois Hematology Oncology — Centralia, Illinois, United States
• Alexian Brothers Hospital Network — Elk Grove Village, Illinois, United States
• Clintell, Inc. — Skokie, Illinois, United States
• Cancer Care Center, Inc. — New Albany, Indiana, United States
• Siouxland Hematology Oncology Associates — Sioux City, Iowa, United States
• Hutchinson Clinic — Hutchinson, Kansas, United States
• Purchase Cancer Group — Paducah, Kentucky, United States
• Medical Oncology, LLC — Baton Rouge, Louisiana, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Kalamazoo Hematology and Oncology — Kalamazoo, Michigan, United States
• Jackson Oncology Associates, PLLC — Jackson, Mississippi, United States
• St. Louis Cancer Care, LLP — Chesterfield, Missouri, United States
• Nebraska Hematology-Oncology, PC — Lincoln, Nebraska, United States
• Great Plains Regional Medical Center — North Platte, Nebraska, United States
• Southern Nevada Cancer Research Foundation — Las Vegas, Nevada, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States

Full record on ClinicalTrials.gov

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