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Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in Elderly Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndromes, Chronic Myelogenous Leukemia

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Trial Information

Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in Elderly Patients


Previous studies of Clofarabine and Cytarabine combination treatment in adult AML and MDS
patients showed promising results.

This study is done to confirm the findings from previous studies. Primary objective is to
determine the overall response rate (complete response [CR] plus partial response [PR]);
secondary objective of this study is to characterize and quantify the toxicity profile
associated with clofarabine plus cytarabine treatment.

The patients eligible for enrollment must be >18 years and have standard or poor cytogenetic
risk AML in first relapse or primary refractory status or untreated high-risk (>10% blasts)
MDS or chronic myelogenous leukemia (CML) in accelerated phase or blast crisis failing
imatinib therapy or selected elderly patients with untreated AML who are at high risk of
anthracycline toxicity. Excluded are FAB M3 AML, patients eligible for allogeneic
transplant(availability of the donor and appropriate performance status and organ
functions).

A maximum of 35 patients will be treated on this study. They will receive 5 consecutive days
of clofarabine IVI followed 4 hours later by cytarabine IVI. Next cycle will start
approximately 4 weeks after Day 1 of previous cycle.


Adult patients who are at least 18 years old with histologically confirmed disease as
follows:

- Standard or poor cytogenetic risk acute myelogenous leukemia (AML) according to the
Southwestern Oncology Group (SWOG) criteria in first relapse or primary refractory
status

- Untreated high-risk myelodysplastic syndrome (MDS) defined as >10% blasts

- Chronic myelogenous leukemia (CML) in accelerated phase or blast crisis failing
imatinib therapy.

- Selected elderly patients with untreated AML who are at high risk of anthracycline
toxicity.

Inclusion Criteria:



1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or

2. Capable of understanding the investigational nature, potential risks and benefits of
the study, and able to provide valid informed consent.

3. Female patients of childbearing potential must have a negative serum pregnancy test
within 2 weeks prior to enrollment.

4. Male and female patients must use an effective contraceptive method during the study
and for a minimum of 6 months after study treatment.

Exclusion Criteria:

1. Patients with FAB M3 unless relapsed after treatment with ATRA and arsenic trioxide.

2. Patients eligible to receive curative allogeneic transplant as determined by
performance status, organ function, availability of a matched donor, etc.

3. Current concomitant chemotherapy, radiation therapy, or immunotherapy.

4. 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.

5. Active heart disease including myocardial infarction within the preceding 3 months.

6. History of severe coronary artery disease, arrhythmias other than atrial flutter or
fibrillation requiring medication, or uncontrolled congestive heart failure

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete response [CR] plus partial response [PR])

Outcome Time Frame:

Four months after the last dose of study drug

Safety Issue:

No

Principal Investigator

Edward Agura, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor University Medical Center - Director Blood and Marrow Transplantation Services

Authority:

United States: Food and Drug Administration

Study ID:

004-145

NCT ID:

NCT00334074

Start Date:

September 2004

Completion Date:

April 2008

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndromes
  • Chronic Myelogenous Leukemia
  • AML
  • MDS
  • Relapsed
  • Refractory
  • Chemo treatment
  • Clofarabine
  • standard or poor cytogenetic risk AML in first relapse or primary refractory status;
  • untreated high-risk (>10% blasts) MDS
  • chronic myelogenous leukemia (CML) in accelerated phase or blast crisis failing imatinib therapy
  • selected elderly patients with untreated AML who are at high risk of anthracycline toxicity
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Baylor University Medical CenterDallas, Texas  75246