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

Alternate Title

Phase III Randomized Study of Allogeneic or Autologous Stem Cell Transplantation Versus Conventional Consolidation and Maintenance Chemotherapy in Patients With Acute Lymphoblastic Leukemia in First Remission

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	15 to 65	NCI	ECOG-2993 MRC-LEUK-UKALL-XII, EST-4491, INT-0132, NCT00002514

Trial Description

Purpose:

Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia.

This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.

Eligibility:

Eligibility criteria include the following:

• 15-65 years old
• No previous therapy for acute lymphoblastic leukemia (other than corticosteroids)
• 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:

Patients will receive intravenous and intrathecal four- and five-drug combination chemotherapy during an 8-week period. Some patients will also receive radiation therapy. Patients will receive three-drug combination chemotherapy during weeks 12-16. Some patients will also receive imatinib mesylate by mouth once a day for at least 4 weeks. Patients will then be assigned to one of two groups.

Patients in group one will have stem cells collected followed by total-body irradiation and high-dose chemotherapy. Three days later, patients will undergo either autologous or allogeneic stem cell transplantation followed by an injection of sargramostim once a day until blood counts return to normal. They will then receive imatinib mesylate by mouth once a day for as long as benefit is shown.

Patients in group two will receive 3-drug combination chemotherapy for approximately 4 weeks. Some patients may then undergo donor stem cell transplantation. Other patients will be randomly assigned to one of two groups:

• Group one: Patients will receive standard combination chemotherapy for up to approximately 2.5 years.
• Group two: Patients will have stem cells collected followed by total-body irradiation and high-dose chemotherapy. Three days later, they will undergo autologous stem cell transplantation followed by an injection of sargramostim once a day until blood counts return to normal.

All patients will be evaluated every 6 months for 2 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

Eastern Cooperative Oncology Group

Jacob Rowe, MD, Protocol chair		Ph: 972-4-854-2541 Email: rowe@rambam.health.gov.il
Mark Litzow, MD, Protocol co-chair		Ph: 507-284-2511 Email: litzow.mark@mayo.edu

Medical Research Council's Working Party on Leukemia in Adults and Children

Antony H. Goldstone, FRCP, Protocol chair		Ph: 44-20-7380-9678 Email: anthony.golstone@uclh.org

Registry Information
Official Title		Phase III Randomized Trial of Autologous and Allogeneic Stem Cell Transplantation Versus Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission
Trial Start Date		1993-04-07
Registered in ClinicalTrials.gov		NCT00002514
Date Submitted to PDQ		1996-07-17
Information Last Verified		2007-08-09
NCI Grant/Contract Number		CA21115

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