Related Links Educational Materials About Clinical Trials Clinical Trials: Questions and Answers Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Alternate Title

Phase III Randomized Study of Daunorubicin and Cytarabine With or Without Gemtuzumab Ozogamicin Followed By Autologous Hematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia (Autologous Transplantation Arm II Closed to Accrual as of 10/4/2007)

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 16 to 60 NCI ECOG-1900 E1900, NCT00049517

Special Category: CTSU trial

Trial Description

Purpose:

Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient’s immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient’s bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient’s stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.

This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.

Eligibility:

Eligibility criteria include the following:

• 16-60 years old
• No previous biological therapy, chemotherapy (other than hydroxyurea), or radiation therapy for any cancer
• 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 be randomly assigned to one of two groups. Patients in group one will receive an infusion of standard- dose daunorubicin once a day for 3 days and a 7-day continuous infusion of cytarabine. Patients in group two will receive an infusion of high-dose daunorubicin once a day for 3 days and a 7-day continuous infusion of cytarabine. Treatment may be repeated in both groups as in group one. Patients may then receive either combination chemotherapy plus autologous stem cell transplant or allogeneic stem cell transplant.

Autologous transplant: Within 2-8 weeks, patients will receive an infusion of high-dose cytarabine twice a day on days 1, 3, and 5. Treatment will be repeated 3 weeks after blood counts have returned to normal. Patients will receive injections of filgrastim once a day for 4 days followed by stem cell collection. Patients will then be randomly assigned to one of two groups.

• Group one: Within 1 month after stem cell collection, patients will receive combination chemotherapy for 6 days followed 2 days later by stem cell transplant. They will then receive injections or infusions of sargramostim or filgrastim until blood counts return to normal.



• Group two: Within 2-4 weeks after stem cell collection, patients will receive a 2-hour infusion of gemtuzumab ozogamicin on day 1. Beginning on day 10, they will receive injections or infusions of sargramostim until blood counts return to normal. Two to 3 weeks later, these patients will receive combination chemotherapy, sargramostim, and stem cell transplant as in group one.

Allogeneic transplant: Within 1-3 months, patients will receive an infusion of busulfan every 6 hours on days 1-4 and a 4-hour infusion of cyclophosphamide on days 5 and 6. Allogeneic bone marrow or stem cells will be infused on day 8. For 6 months after transplantation, patients will receive treatment by infusion and by mouth to prevent graft-versus-host disease (GVHD).

All patients will be evaluated once a month for 1 year, every 2 months for 1 year, and every 3 months for up to 7 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

Hugo Fernandez, MD, Protocol chair		Ph: 813-745-6012; 888-663-3488 Email: hugo.fernandez@moffitt.org

Registry Information
Official Title		A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification and Gemtuzumab-Ozogamicin Consolidation Therapy Prior to Autologous Stem Cell Transplantation
Trial Start Date		2002-12-16
Trial Completion Date		2007-03-21 (estimated)
Registered in ClinicalTrials.gov		NCT00049517
Date Submitted to PDQ		2002-09-20
Information Last Verified		2008-11-13
NCI Grant/Contract Number		CA21115