Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by East Valley Hematology and Oncology Medical Group.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Mena, Raul, M.D.
Pharmatech Oncology
Astex Pharmaceuticals
Information provided by:
East Valley Hematology and Oncology Medical Group
ClinicalTrials.gov Identifier:
NCT00131313
First received: August 16, 2005
Last updated: August 17, 2005
Last verified: August 2005
  Purpose

This research study measures the safety and efficacy of the combination of three drugs that are approved, Nipent, Rituxan and Cytoxan in the treatment of Chronic Lymphocytic Leukemia (CLL). These drugs are being given together for investigational purposes as the specific combination of these three drugs has not been approved for treatment of CLL by the FDA.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Nipent, Cytoxan, Rituxan
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.

Resource links provided by NLM:


Further study details as provided by East Valley Hematology and Oncology Medical Group:

Primary Outcome Measures:
  • Efficacy response rate

Secondary Outcome Measures:
  • Time to progression
  • Time to treatment failure
  • Toxicity
  • Incidence and severity of adverse events

Estimated Enrollment: 180
Study Start Date: January 2003
Estimated Study Completion Date: April 2009
Detailed Description:

Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S. Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and is clinically promising. It is expected that the addition of Cytoxan in patients with previously untreated CLL and patients who have relapsed or failed prior therapy may benefit from combined therapy using Nipent, Cytoxan and Rituxan. It is unknown how the addition of Cytoxan will affect the toxicity profile of the Rituxan and Nipent regimen, however, patients will be monitored for toxicities. It is expected that bone marrow toxicities will not increase to unreasonable levels.

The primary objective of the study is to determine the overall efficacy response rate following treatment with Nipent, Cytoxan and Rituxan of patients with previously untreated or treated CLL. The secondary objectives of the study are to determine the duration of response, time to progression, time to treatment failure and to evaluate the toxicity of this combination of drugs and the incidence and severity of adverse events.

  Eligibility

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

Inclusion Criteria:

  • Stage II, III or IV Chronic Lymphocytic Leukemia
  • Disease requires chemotherapeutic treatment
  • CT or MRI scan confirming measurable tumor size
  • Documentation of CD markers
  • Up to one prior treatment regimen
  • Expected survival greater than 6 months
  • ECOG performance status of 0-2
  • Adequate renal, bone marrow and liver functions
  • Negative pregnancy test (females of childbearing potential)
  • Must agree to use acceptable birth control, if fertile
  • Must complete Informed Consent
  • No heart disease and must have adequate cardiac function
  • Must test negative for viral Hepatitis B and C

Exclusion Criteria:

  • More than one prior treatment for Chronic Lymphocytic Leukemia
  • Known sensitivity to Nipent, Rituxan or Cytoxan or any component of these drugs
  • Known HIV or AIDS illness
  • Thyroid disease requiring medication
  • History of any malignancy that could affect the diagnosis or assessment of the study treatment
  • Pregnancy or breast feeding
  • Evidence of Hepatitis B or C infection
  • Inability to comply with the requirements of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131313

Contacts
Contact: Tracy Latimer 720-917-7478 tracyl@pharmatech.com

  Show 52 Study Locations
Sponsors and Collaborators
East Valley Hematology and Oncology Medical Group
Mena, Raul, M.D.
Pharmatech Oncology
Astex Pharmaceuticals
Investigators
Principal Investigator: Raul Mena, MD East Valley Hematology and Oncology Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00131313     History of Changes
Other Study ID Numbers: POI-02818, NIP-02-005
Study First Received: August 16, 2005
Last Updated: August 17, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by East Valley Hematology and Oncology Medical Group:
Leukemia
Cancer
Nipent
Rituxan
Cytoxan

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 July 20, 2014