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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astex Pharmaceuticals
Information provided by (Responsible Party):
John Byrd, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201721
First received: September 12, 2005
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
B-Chronic Lymphocytic Leukemia
Drug: Pentostatin
Drug: Rituximab
Drug: Cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • To assess the rate of complete and overall response using rituximab and pentostatin with and without cyclophosphamide. [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: July 2002
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pentostatin
    2 mg/m2 IV over 30 minutes in 250 mL NS on day 1 during cycles 1-6.
    Other Name: Nipent®
    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.
    Other Name: RITUXAN®
    Drug: Cyclophosphamide
    600 mg/m2 IV in 250 mL NS over 30 minutes on day 1 cycles 1-6
    Other Name: CTX
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201721

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
John Byrd
Astex Pharmaceuticals
Investigators
Principal Investigator: John Byrd Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: John Byrd, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201721     History of Changes
Obsolete Identifiers: NCT00423423
Other Study ID Numbers: OSU-0143
Study First Received: September 12, 2005
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Previously Untreated

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Pentostatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adenosine Deaminase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014