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Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias

Phase 1
1 Year
21 Years
Open (Enrolling)
Myelodysplastic Syndrome, Acute Myeloid Leukemia, Myeloproliferative Disorders, Acute Lymphocytic Leukemia, Acute Promyelocytic Leukemia, Acute Leukemia, Chronic Myelogenous Leukemia, Myelofibrosis, Chronic Myelomonocytic Leukemia, Juvenile Myelomonocytic Leukemia

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Trial Information

Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 for
adolescent/young adult patients.

- Lansky Performance Index > 50 for pediatric patients less than age 10 years.

- Laboratory values obtained < 7 days prior to receiving study treatment:

- Total bilirubin < 1.5 mg/dL unless elevated due to hemolysis. The conjugated serum
bilirubin prior to study entry must be within the normal range.

- Aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 × upper limit of
normal (ULN)

- Serum creatinine < 1.0 mg/dL in adolescent/young adults (patients 12 to 17 years of
age). For pediatric patients with serum creatinine above the ULN, creatinine
clearance > 90 ml/min/1.73m2 calculated using the Schwartz formula may be enrolled.
Collected creatinine clearance may be substituted.

Patients 18 years and older (Adult population): Serum creatinine <1.0 mg/dL; if serum
creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60
mL/min/1.73 m2

- Cardiac function must be normal per the institution normal as measured by
echocardiogram (ECHO) within 7 days.

- Patients should have no evidence of myositis as detected by abnormal serum creatine
kinase and/or myoglobin.

Exclusion Criteria:

- No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of
study drug except for 5-azacytidine, thalidomide, hydroxyurea, imatinib (Gleevec),
and interferon which must be discontinued at least 3 days before study entry and the
patient should have recovered from the toxic side effects of such therapy. In the
instance of progressive disease, anti-leukemia therapy may have been administered
within the 2-week period as long but the subject should have recovered from the toxic
effects of that therapy. Also, intrathecal therapy may be administered within the
2-week period for subjects with CNS disease.

- Patients who have had an allogeneic or autologous hematopoietic stem cell transplant.

- Patients must have discontinued all growth factors, except Procrit (epoetin), at
least 1 week before study.

- Patients with known HIV positive status or AIDS.

- Patients with known active Hepatitis B, Hepatitis C or cirrhosis.

- History of severe coronary artery disease, including myocardial infarction within the
previous 3 months, arrhythmias other than atrial flutter or fibrillation requiring
medication, or uncontrolled congestive heart failure.

- Patients with active uncontrolled infection, fever of infection, or evidence for
progressive disease by CT scans of the lungs, sinuses, or abdomen. Patients who are
on antimicrobial therapy and stable, CT scans must have been stable for 4 weeks, may
be enrolled but there must be no evidence of an active infection. Patients with fever
due to leukemia may be enrolled.

- Pregnant or lactating patients. Female patients of childbearing potential must have
a negative serum pregnancy test within 14 days before study entry.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the feasibility, tolerability, toxicities, and MTD of clofarabine followed by fractionated cyclophosphamide in pediatric patients with relapsed or refractory acute leukemias.

Outcome Time Frame:

1 cycle

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

Related Keywords:

  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Myeloproliferative Disorders
  • Acute Lymphocytic Leukemia
  • Acute Promyelocytic Leukemia
  • Acute Leukemia
  • Chronic Myelogenous Leukemia
  • Myelofibrosis
  • Chronic Myelomonocytic Leukemia
  • Juvenile Myelomonocytic Leukemia
  • Myelodysplastic syndrome that has transformed to AML (AML/MDS)
  • Treatment-related AML
  • AML evolving from myeloproliferative disorders (MPD)
  • Acute lymphocytic leukemia (ALL)
  • Acute promyelocytic leukemia (APL) refractory to arsenic therapy or retinoic acid therapy
  • Relapsed and/or refractory acute leukemia with progressive disease since last therapy
  • Chronic myelogenous leukemia (CML) in accelerated phase or blast crisis refractory to imatinib
  • High-risk MPD including myelofibrosis, chronic myelomonocytic leukemia (CMML, and relapsed or refractory juvenile myelomonocytic leukemia (JMML).
  • Primary Myelofibrosis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Promyelocytic, Acute
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Myeloproliferative Disorders
  • Acute Disease
  • Leukemia, Myelomonocytic, Juvenile



Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Vanderbilt Children's Hospital Nashville, Tennessee  37232-6310
Children's Healthcare of Atlanta Atlanta, Georgia  30342
University of Colorado Health Sciences Center and The Children's Hospital Aurora, Colorado  80045
Pediatrix Hematology/Oncology University of Florida College of Medicine Gainesville, Florida  32610-0296
M.D. Anderson Comprehensive Cancer Center Houston, Texas  77030