Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia

Conditions

• B-Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pentostatin — DRUG
  2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.
• Rituximab — DRUG
  For the first week only: Day 1 of therapy 100 mg IV over 4 hours. Day 3 of therapy 375 mg/m2 IV at 50 mg/hr and increase by 100 mg/hr at 30-minute intervals to a maximum of 400 mg/hr. Day 5 of therapy 375 mg/m2 IV at 100 mg/hr for the first 15 minutes the remainder goes in at 45 minutes. The remaining weeks 375 mg/m2 will be repeated as a single IV infusion Day 1 of Week 4, 7, 10, 13 and 16 during cycles 2-6.
• Cyclophosphamide — DRUG
  600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6

Study Details

This study aims to assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide, to monitor and assess toxicity of this regimen, and to determine the overall and progression-free survival in CLL patients

Key Dates

Start date

Jul 31, 2002

Status verified

Feb 2017

Primary completion

Jul 31, 2006

Completion

Sep 30, 2006

Study Design

Enrollment

28 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Primary Outcome Measure

To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide. [ Time Frame: up to 5 years ]

Locations (1)

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