Clofarabine Plus Cytarabine in Patients With Previously Untreated Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome

NCT00065143 | Completed Phase 2

• 1 other identifier: ID03-0139
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if clofarabine, when given in combination with ara-C (cytarabine), can help to improve the disease's response to therapy and to increase the duration of response in patients who are 50 years or older with leukemia. The safety of this combination treatment will also be studied.

Conditions

Leukemia, Myeloid; Myelodysplastic Syndromes

Keywords

Newly diagnosed and previously untreated acute myeloid leukemia (AML); High-risk myelodysplastic syndrome (MDS) (>/= 10% bone marrow blasts); Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS)

Interventions

clofarabine DRUG

Ara-C DRUG

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) (\> 10% blasts). Prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed.
• Age \> 50 years to \< 74 years (diploid cytogenetics) and \< 69 years (abnormal cytogenetics).
• ECOG performance status \</= 2.
• Sign a written informed consent form.
• Adequate liver function (total bilirubin \< 2mg/dL, SGPT or SGOT \< x 4 ULN) and renal function (serum creatinine \< 2mg/dL).
• Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient is of childbearing potential. Non-childbearing is defined as \>= 1 year postmenopausal or surgically sterilized).
• Patients who are considered to require immediate induction (rapidly rising WBC \>/= 50,000 and/or organ involvement as per the assessment of the treating physician) can be treated without final cytogenetic results and pretreatment assessment of cardiac ejection fraction (MUGA or echocardiogram) if by history and physical examination patients have \</= NYHA class II disease.

You may not qualify if:

• Active and uncontrolled infection or any other severe concurrent disease considered life-threatening, or which, in the judgement of the investigator and after discussion with the Principal Investigator, would make the patient inappropriate for entry into the study.

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

• Website for The University of Texas M.D. Anderson Cancer Center

MeSH Terms

Conditions

Leukemia, Myeloid; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Interventions

Clofarabine; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

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; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Stefan Faderl, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 17, 2003
• First Posted: July 18, 2003
• Study Start: June 23, 2003
• Primary Completion: February 22, 2006
• Study Completion: February 22, 2006
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

US (1)