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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00131313
Recruitment Status : Unknown
Verified August 2005 by East Valley Hematology and Oncology Medical Group.
Recruitment status was:  Recruiting
First Posted : August 18, 2005
Last Update Posted : August 18, 2005
Mena, Raul, M.D.
Pharmatech Oncology
Astex Pharmaceuticals
Information provided by:
East Valley Hematology and Oncology Medical Group

August 16, 2005
August 18, 2005
August 18, 2005
January 2003
Not Provided
Efficacy response rate
Same as current
No Changes Posted
  • Time to progression
  • Time to treatment failure
  • Toxicity
  • Incidence and severity of adverse events
Same as current
Not Provided
Not Provided
Efficacy and Safety of Nipent, Cytoxan and Rituxan in the Treatment of Chronic Lymphocytic Leukemia.
A Multicenter, Open-Label Study of Nipent, Cytoxan and Rituxan in Patients With Previously Untreated or Treated Chronic Lymphocytic Leukemia.
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.

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.

Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
Drug: Nipent, Cytoxan, Rituxan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
April 2009
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
East Valley Hematology and Oncology Medical Group
  • Mena, Raul, M.D.
  • Pharmatech Oncology
  • Astex Pharmaceuticals
Principal Investigator: Raul Mena, MD East Valley Hematology and Oncology Group
East Valley Hematology and Oncology Medical Group
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP