Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia

Conditions

• Stage I Chronic Lymphocytic Leukemia
• Stage II Chronic Lymphocytic Leukemia
• Stage III Chronic Lymphocytic Leukemia
• Stage IV Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cyclophosphamide — DRUG
  Given IV
• Fludarabine Phosphate — DRUG
  Given IV or PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Lenalidomide — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV

Study Details

This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and rituximab with or without lenalidomide or cyclophosphamide work in treating patients with symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic leukemia.

Key Dates

Start date

Jan 15, 2008

Status verified

Apr 2023

Primary completion

Dec 1, 2014

Completion

Apr 15, 2023

Study Design

Enrollment

418 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (rituximab, fludarabine phosphate)
  Participants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5.
• Experimental: Arm B (rituximab, fludarabine phosphate, lenalidomide)
  Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
• Experimental: Arm C (rituximab, fludarabine phosphate, cyclophosphamide)
  Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3.
• Experimental: Arm D (rituximab, fludarabine, cyclophosphamide, lenalidomide)
  Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m\^2) on day 1 and fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) and cyclophosphamide IV (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.

Primary Outcome Measure

2-Year Progression Free Survival (PFS) Rate [ Time Frame: 2 years ]

Locations (355)

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