Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

Millennium Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Follicular Lymphoma

Treatments: Drug: rituximab; Drug: fludarabine; Drug: VELCADE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00850499

26866138-LYM-2033

Details and patient eligibility

About

This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects 18 years or older
• Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification
• Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
• Documented relapse or progression following last antineoplastic treatment
• At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)

Exclusion criteria

• Subjects with histological or clinical transformation to an aggressive lymphoma

  • prior treatment with VELCADE or fludarabine.
  • antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
  • nitrosoureas within 6 weeks before randomization
  • radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
  • major surgery within 3 weeks before randomization
  • chronic use of corticosteroids, such as dexamethasone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

VELCADE and fludarabine (Group A)

Experimental group

Description:

VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle

Treatment:

Drug: VELCADE

Drug: fludarabine

fludarabine and rituximab (Group B)

Active Comparator group

Description:

fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle

Treatment:

Drug: rituximab

Drug: fludarabine