Investigation of Clofarabine in Acute Leukemias

NCT00098033 | Completed Phase 2

• 1 other identifier: 2127
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.

Conditions

Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia

Keywords

clinical; pharmacodynamics; investigational drug clofarabine; AML, ALL, CML-accelerated phase, CML-blastic phase; Chronic Myelogenous Leukemia - accelerated phase; Chronic Myelogenous Leukemia - blastic phase

Interventions

clofarabine DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase). * No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician. * Adequate liver function (bilirubin \</= 2 mg%) and renal function (creatinine \</= 2 mg%). * Pregnant and lactating females not eligible. * Zubrod performance status 0-2 * Adequate cardiac status * No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas: lead

Related Publications (1)

• Cortes JE, Gandhi V, et al. Clofarabine (2-chloro-9-(deoxy-2-fluoro-b-D-arabinosfuranosyl)adenine) is active for patients with refractory or relapsed acute leukemia. #739 ASH 2002.

  BACKGROUND

Related Links

• FDA's clinical trials website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Accelerated Phase; Blast Crisis

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes

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

• Hagop M Kantarjian, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Jorge E Cortes, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2004
• First Posted: December 3, 2004
• Study Start: September 1, 2002
• Study Completion: September 1, 2005
• Last Updated: March 25, 2015

Record last verified: 2004-12