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A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab


Phase 2
18 Years
N/A
Not Enrolling
Both
Follicular Lymphoma

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Trial Information

A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete Response Rate

Outcome Description:

The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.

Outcome Time Frame:

Up to 8 cycles (1 cycle is 35 days: 280 days)

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Authority:

United States: Food and Drug Administration

Study ID:

26866138-LYM-2033

NCT ID:

NCT00850499

Start Date:

September 2009

Completion Date:

October 2011

Related Keywords:

  • Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular

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