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

February 6, 2017 updated by: John Byrd, Ohio State University Comprehensive Cancer Center

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

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

Study Overview

Status

Completed

Conditions

B-Chronic Lymphocytic Leukemia

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Columbus, Ohio, United States, 43210
    - Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
To monitor and assess toxicity of this regimen. Time Frame: up to 5 years	up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

Astex Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Jamesline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria