Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• denileukin diftitox — BIOLOGICAL
• rituximab — BIOLOGICAL

Study Details

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to cancer cells. Giving rituximab together with denileukin diftitox may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with denileukin diftitox works in treating patients with previously untreated stage III or stage IV follicular B-cell non-Hodgkin's lymphoma.

Key Dates

Start date

Apr 30, 2008

Status verified

Mar 2017

Primary completion

Oct 31, 2010

Completion

Mar 31, 2011

Study Design

Enrollment

24 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: rituximab + denileukin diftitox
  Patients receive rituximab IV on days 1, 8, 15, and 22. Patients also receive denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response) [ Time Frame: Up to 5 years ]

Locations (165)

Find similar trials in Scottsdale, AZ

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