Oral Clofarabine in Chronic Lymphocytic Leukemia (CLL)

NCT00800566 | Withdrawn Phase 1 DMC

• 1 other identifier: 2007-0905
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia; Chronic Lymphocytic Leukemia

Keywords

Clofarabine; Leukemia; Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) and Dose limiting toxicities (DLT)

  October 2009

Secondary Outcomes (1)

• To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile in CLL.

  October 2010

Study Arms (1)

Oral Clofarabine

EXPERIMENTAL

Drug: Oral Clofarabine

Interventions

Oral Clofarabine DRUG

The starting dose will be 1 mg orally daily x 21 days every 4 weeks +/- 4 days.

Also known as: Clolar®

Oral Clofarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson's Website

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides

Study Officials

• Stefan F. Faderl, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)