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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2006-09-30

Brief Summary

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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

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Detailed Description

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Rationale: Research indicates that both cyclophosphamide and pentostatin work synergistically against cancer cells and have a high response rate against chronic lymphocytic leukemia (CLL) without creating severe side effects in patients. In addition, studies have shown that rituximab, a therapy that targets the immune system, has the highest efficacy against CLL and the lowest toxicity rate when compared with other immunotherapy drugs. Studies also show that rituximab enhances the efficacy of the chemotherapy agents cyclophosphamide and pentostatin. This study offers the combination of immunotherapy with two promising chemotherapy agents against CLL.

Purpose: This study is evaluating the efficacy and safety of combination treatment with cyclophosphamide, pentostatin, and rituximab in patients with CLL. Several tests evaluating the genetic and molecular components of CLL will also be performed. Some of these tests will be conducted before, during, and after treatments to assess changes resulting from the study drugs. Each patient's outcome will be assessed in relation to various aspects of their genes.

Conditions

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B-Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pentostatin

2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.

Intervention Type DRUG

Rituximab

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.

Intervention Type DRUG

Cyclophosphamide

600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6

Intervention Type DRUG

Other Intervention Names

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Nipent® RITUXAN® CTX

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of B-CLL (no mantle cell)
* Must have active disease
* Age \>=18 yo
* ECOG 0-3
* No radiation or surgery \<4 weeks

Exclusion Criteria

* Any of the following comorbid conditions:

* New York Heart Association Class III or IV heart disease
* Recent myocardial infarction (\<1 month)
* Uncontrolled infection
* Active infection with the human immunodeficiency virus (HIV/AIDS) as further severe immunosuppression with this regimen may occur.
* Pregnant or nursing women
* Men or women of child bearing potential must use adequate contraception.
* Active primary malignancy requiring treatment or limits survival to ≤2 years.
* Any radiation therapy ≤4 weeks prior to study entry.
* Any major surgery ≤4 weeks prior to study entry.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No