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

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00201721

Collaborator

Astex Pharmaceuticals, Inc. (Industry)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
B-Chronic Lymphocytic Leukemia	Drug: Pentostatin Drug: Rituximab Drug: Cyclophosphamide	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Pentostatin, and Rituximab With and Without Cyclophosphamide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL)

Study Start Date :

Jul 1, 2002

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide. [up to 5 years]
For this evaluation, patients will be classified as complete responders if either of the following types of response are documented CCR (Clinically based complete remission) denotes NED (No Evidence of Disease) based on baseline clinical parameters. CR denotes CCR and, in bone marrow, no nodules and <30% lymphocytes.

Secondary Outcome Measures

To monitor and assess toxicity of this regimen. [up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.