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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 — POE07-01  

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Summary

This is a Phase I study designed to determine the MTD and assess the toxicity associated with clofarabine followed by fractionated cyclophosphamide in patients > 1 year of age or < 21 years of age with relapsed or refractory acute leukemias. There will be 25 to 35 patients enrolled. Cohorts of 3 to 6 patients each will receive escalated doses of clofarabine followed by fractionated cyclophosphamide until the MTD is reached. There will be no intra-patient dose escalation. Single-agent cyclophosphamide will be administered by 2-hour IVI on Day 0 of cycle 1. On Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be administered by IVI 2 hours before each dose of cyclophosphamide (see the treatment schema below). A cycle is defined as 28 days.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Acute Disease
  • Acute Leukemia
  • Acute Lymphocytic Leukemia
  • Acute Myeloid Leukemia
  • Acute Promyelocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Chronic Myelomonocytic Leukemia
  • Juvenile Myelomonocytic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Juvenile
  • Leukemia, Promyelocytic, Acute
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Myelofibrosis
  • Myeloproliferative Disorders
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Primary Myelofibrosis
Clinical Trial Details
NCT number NCT00852709
Study type Interventional
Source Sidney Kimmel Comprehensive Cancer Center
Contact
Status Terminated
Phase Phase 1
Start date September 1, 2007
Completion date November 20, 2009
View Details
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