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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Study of Clofarabine and Cytarabine in Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia (Phase I Closed to Accrual as of 09/16/09)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Treatment	Temporarily closed	1 to 30	NCI	COG-AAML0523 AAML0523, NCT00372619

Trial Description

Purpose:

Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)

Eligibility:

Eligibility criteria include the following:

• 1-30 years old
• No acute promyelocytic leukemia
• No more than one previous stem cell transplant
• At least 4 months since transplant
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Some patients will receive intrathecal cytarabine in week 1 of course one and intrathecal methotrexate in week 1 of course two and of all other courses. All patients will receive 2-hour infusions of cytarabine and clofarabine once a day for 5 days. No more than 6 weeks later, patients will receive a second course of treatment.

Beginning 2-6 weeks after the second course of chemotherapy, some patients will receive 2-hour infusions of clofarabine and cytarabine once a day for 5 days. Treatment may repeat every 2-6 weeks for up to 10 courses.

Patients may undergo blood and bone marrow sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated periodically for up to 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Bassem Razzouk, MD, Protocol chair		Ph: 317-338-4673 Email: bassem.razzouk@stjude.org
Todd Cooper, DO, Protocol co-chair		Ph: 205-939-9285 ext. 5855

Registry Information
Official Title		A Phase I/II Study of CLOLAR® (Clofarabine, IND# 73, 789) in Combination with Cytarabine in Pediatric Patients with Refractory/Relapsed Leukemia
Trial Start Date		2007-03-12
Trial Completion Date		2010-11-19 (estimated)
Registered in ClinicalTrials.gov		NCT00372619
Date Submitted to PDQ		2006-06-30
Information Last Verified		2009-11-24
NCI Grant/Contract Number		CA98543

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