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Oral Clofarabine in Chronic Lymphocytic Leukemia (CLL)
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Genzyme
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00800566
  Purpose

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.

Optional Procedures: You may be asked to have extra blood drawn for pharmacokinetic (PK) and pharmacodynamic (PD) testing. PK testing measures the amount of study drug in the body at different time points. PD testing is used to look at how the level of study drug in your body may affect the disease


Condition Intervention Phase
Leukemia
Chronic Lymphocytic Leukemia
Drug: Oral Clofarabine
Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Clofarabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I Study of Oral Clofarabine for the Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of oral clofarabine in patients with relapsed and refractory CLL. [ Time Frame: October 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile in CLL. [ Time Frame: October 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: November 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Oral Clofarabine
Drug: Oral Clofarabine
The starting dose will be 1 mg orally daily x 21 days every 4 weeks +/- 4 days.

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  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800566

Contacts
Contact: Stefan F. Faderl, M.D. 713/745-4613 sfaderl@mdanderson.org

Locations
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Stefan Faderl, M.D.     713-745-4613     sfaderl@mdanderson.org    
Principal Investigator: Stefan Faderl, M.D.            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genzyme
Investigators
Principal Investigator: Stefan F. Faderl, M.D. M.D. Anderson Cancer Center
  More Information

M.D. Anderson's Website  This link exits the ClinicalTrials.gov site

Responsible Party: The University of Texas M.D. Anderson Cancer Center ( Stefan Faderl, M.D./Associate Professor )
Study ID Numbers: 2007-0905
Study First Received: December 1, 2008
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00800566  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Clofarabine
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009