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

Phase 2

Completed

• Conditions: B-Chronic Lymphocytic Leukemia

• Registration Number: NCT00201721
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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

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 Timeline

• Study Start: 2002-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-07
• Study Completion: 2006-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To monitor and assess toxicity of this regimen.	up to 5 years

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States