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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00070174 |
Purpose
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: asparaginase Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: gemtuzumab ozogamicin Drug: methotrexate Drug: mitoxantrone hydrochloride Procedure: allogeneic bone marrow transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study |
| Study Start Date: | December 2003 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
In all courses, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed primary acute myeloid leukemia (AML)
Meets the customary FAB criteria for AML
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 148 Study Locations| Study Chair: | Janet Franklin, MD, MPH | Children's Hospital Los Angeles |
More Information
| ClinicalTrials.gov Identifier: | NCT00070174 History of Changes |
| Other Study ID Numbers: | CDR0000330133, COG-AAML03P1 |
| Study First Received: | October 3, 2003 |
| Last Updated: | September 9, 2011 |
| Health Authority: | United States: Federal Government |
|
untreated childhood acute myeloid leukemia and other myeloid malignancies childhood acute monocytic leukemia (M5b) childhood acute megakaryocytic leukemia (M7) childhood acute minimally differentiated myeloid leukemia (M0) childhood acute myeloblastic leukemia with maturation (M2) |
childhood acute myeloblastic leukemia without maturation (M1) childhood acute myelomonocytic leukemia (M4) childhood acute monoblastic leukemia (M5a) childhood acute erythroleukemia (M6) |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Gemtuzumab Asparaginase Busulfan Cyclophosphamide Cytarabine Daunorubicin Etoposide Methotrexate Mitoxantrone Cyclosporins |
Cyclosporine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antirheumatic Agents Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |