Oral Clofarabine in Chronic Lymphocytic Leukemia (CLL)

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: NCT00800566
Recruitment Status : Withdrawn (Sponsor terminated.)
First Posted : December 2, 2008
Last Update Posted : August 1, 2012
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of clofarabine when given to patients with CLL. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Leukemia Chronic Lymphocytic Leukemia Drug: Oral Clofarabine Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Oral Clofarabine for the Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
Study Start Date : November 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: Oral Clofarabine Drug: Oral Clofarabine
The starting dose will be 1 mg orally daily x 21 days every 4 weeks +/- 4 days.
Other Name: Clolar®

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) and Dose limiting toxicities (DLT) [ Time Frame: October 2009 ]

Secondary Outcome Measures :
  1. To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile in CLL. [ Time Frame: October 2010 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB [French-American-British Classification]), small lymphocytic lymphoma (SLL) and prolymphocytic leukemia (PLL) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.
  • Absolute neutrophil count (ANC) >= 1 x 109/L and platelet count >= 50 x 109/L.
  • Adequate organ function as indicated by the following laboratory values: serum creatinine </= 1 mg/dL; if serum creatinine > 1 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation; serum bilirubin </= 1.5 mg/dL x ULN; aspartate transaminase (AST)or alanine transaminase (ALT) </= 2.5 x ULN; alkaline phosphatase </= 2.5 x ULN.
  • ECOG performance status <= 2.
  • Age >/= 18 years.

Exclusion Criteria:

  • Patients with NYHA >/= grade 3 heart disease as assessed by history and/or physical examination.
  • Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception. Positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).
  • Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy).
  • Other malignancy within 3 years except in situ carcinoma.
  • Unwilling or unable to provide informed consent.
  • Known hypersensitivity to nucleoside analogues.
  • Any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known hepatitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00800566

United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Principal Investigator: Stefan F. Faderl, M.D. M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00800566     History of Changes
Other Study ID Numbers: 2007-0905
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents