Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS

NCT00334074 | Completed Phase 2 Results

• 1 other identifier: 004-145
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to to determine the safety and effectiveness of therapeutic combination - Clofarabine and Cytarabine for the treatment of AML and MDS.

Conditions

Acute Myelogenous Leukemia; Myelodysplastic Syndromes; Chronic Myelogenous Leukemia

Keywords

AML; MDS; CML; Relapsed; Refractory; Chemo treatment; Clofarabine; Cytarabine; standard or poor cytogenetic risk AML; untreated high-risk (>10% blasts) MDS; CML in accelerated phase or blast crisis; Elderly AML patients with risk of anthracycline toxicity

Outcome Measures

Primary Outcomes (1)

• Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity

  Based on International working group for diagnosis, standardization of response criteria, and treatment outcomes for reporting standards for therapeutic trials in Acute myeloid Leukemia: Complete Response (CR) was defined as normalization of marrow blasts (\< 5%), recovery of normal heamtopoiesis (absolute neutrophil count \>1 X 10\^9/l, platelet count ≥100 X10\^9/l, and absence of peripheral blood blasts, independent of transfusions and growth factor support. Partial response was defined as blood count recovery as for complete response with the exception of leukemic marrow blasts in the range of 6%-25% or a ≥50% decrease in bone marrow blasts. Treatment failure was defined as a \<25% change in marrow blasts within 30 days of starting therapy

  Proportion of confirmed responses was estimated by the number of patients who achieved a CR or PR, defined as two consecutive evaluations at least 4 weeks apart, divided by the number of eligible participants in the study.

Secondary Outcomes (1)

• Number of Participants Who Had an Adverse Event While on Treatment With Clofarabine Plus Cytarabine

  Up to five months (includes follow up period of 30 days) from the day patient received their first dose of study drug

Study Arms (1)

Clofarabine and Cytarabine

EXPERIMENTAL

Five consecutive days of clofarabine 40 mg/m\^2 IVI over 1 hour followed 4 hours later by cytarabine 1000 mg/m\^2 IVI over 2 hours

Drug: Clofarabine and Cytarabine

Interventions

Clofarabine and Cytarabine DRUG

Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in selected Elderly Patients at high risk of anthracycline toxicity

Also known as: Clofarabine: CAFdA; Cl-F-ara-A, Cytarabine: Ara-C

Clofarabine and Cytarabine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
• Laboratory values obtained less than or equal to 7 days prior to receiving study treatment:
• Total bilirubin \< 2.0 mg/dL unless elevated due to hemolysis
• Aspartate transaminase (AST)/alanine transaminase (ALT) less than or equal to 5 × upper limit of normal (ULN)
• Serum creatinine \< 2.0 mg/dL
• Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
• Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
• Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

You may not qualify if:

• Patients with FAB M3 unless relapsed after treatment with ATRA and arsenic trioxide.
• Patients eligible to receive curative allogeneic transplant as determined by performance status, organ function, availability of a matched donor, etc.
• Current concomitant chemotherapy, radiation therapy, or immunotherapy.
• Use of investigational agents within 30 days or any anticancer therapy within 3 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.
• Active heart disease including myocardial infarction within the preceding 3 months.
• History of severe coronary artery disease, arrhythmias other than atrial flutter or fibrillation requiring medication, or uncontrolled congestive heart failure
• Dyspnea at rest or with minimal exertion.
• Patients with an active, uncontrolled systemic infection considered to be opportunistic, life-threatening, or clinically significant at the time of treatment or with a known or suspected fungal infection (ie, patients on parenteral antifungal therapy).
• Pregnant or lactating patients.
• Prior enrollment in this trial.
• Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Recurrence; Blast Crisis

Interventions

Clofarabine; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; 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; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Edward Agura
• Organization: Baylor University Medical Center

Sandyli@baylorhealth.edu

214-818-8472

Study Officials

• Edward Agura, MD

  Baylor University Medical Center - Director Blood and Marrow Transplantation Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 2, 2006
• First Posted: June 6, 2006
• Study Start: August 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2008
• Last Updated: July 17, 2013
• Results First Posted: July 17, 2013

Record last verified: 2013-07

Locations

US (1)