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| Sponsor: | Genzyme |
|---|---|
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00042354 |
Purpose
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Myelogenous Leukemia (AML.)
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myelocytic, Acute, Pediatric |
Drug: clofarabine (IV formulation) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Myelogenous Leukemia |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2002 |
This is a non-randomized, open label, Phase II study of Clofarabine in pediatric patients with refractory or relapsed acute myelogenous leukemia (AML). Eligible patients must be in first or subsequent relapse or be refractory. Forty eligible patients will be enrolled in a Fleming 2-stage sequential study design in order to better assess the efficacy and safety of clofarabine in this patient population.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| Children's Hospital | |
| Los Angeles, California, United States, 90027 | |
| Children's Hospital | |
| Orange County, California, United States | |
| Children's Hospital | |
| San Diego, California, United States | |
| United States, Colorado | |
| Children's Hospital | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Hartford, Connecticut, United States, 06106 | |
| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| United States, Maryland | |
| Johns Hopkins Children's Center | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Missouri | |
| Children's Hospital | |
| St. Louis, Missouri, United States | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 67198 | |
| United States, New York | |
| Memorial Sloan-Kettering | |
| New York, New York, United States | |
| United States, Pennsylvania | |
| Children's Hospital | |
| Philadelphia, Pennsylvania, United States | |
| Children's Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Children's Medical Center | |
| Dallas, Texas, United States | |
| Cook's Children's Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| Texas Children's Cancer Center | |
| Houston, Texas, United States | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00042354 History of Changes |
| Other Study ID Numbers: | CLO222 |
| Study First Received: | July 26, 2002 |
| Last Updated: | July 28, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
CLO222 clolar Pediatric Acute Myelogenous Leukemia |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
Clofarabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |