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Sponsors and Collaborators: |
St. Jude Children's Research Hospital International BFM Study Group |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00186966 |
This is an international multicenter open label randomized phase III trial in children with relapsed and refractory acute myeloid leukemia (AML) such a disease. The main purpose of this study is to determine the efficacy and toxicity of liposomal daunorubicin when added to fludarabine, ara-C and G-CSF(FLAG) in children with relapsed and refractory AML.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia |
Drug: Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome) Drug: Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan Procedure: Hematopoietic stem cell transplant Radiation: Total body irradiation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase III Study of the Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia |
Estimated Enrollment: | 20 |
Study Start Date: | March 2002 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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FLAG |
Drug: Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome)
See Detailed Description section for details of treatment interventions.
Drug: Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan
See Detailed Description section for details of treatment interventions.
Procedure: Hematopoietic stem cell transplant
See Detailed Description section for details of treatment interventions.
Radiation: Total body irradiation
See Detailed Description section for details of treatment interventions.
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FLAG and LP Dox |
Drug: Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome)
See Detailed Description section for details of treatment interventions.
Drug: Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan
See Detailed Description section for details of treatment interventions.
Procedure: Hematopoietic stem cell transplant
See Detailed Description section for details of treatment interventions.
Radiation: Total body irradiation
See Detailed Description section for details of treatment interventions.
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Secondary objectives of this trial are:
Reinduction treatment will be done with 2 courses of combination chemotherapy, with FLAG (fludarabine, ara-C and G-CSF) in both courses as standard treatment. In the first course there will be a randomisation for liposomal daunorubicin (DaunoXome®) to be added or not. The second course should always concern FLAG. If patients have > 20% of blasts in the bone marrow after the 1st course, or if they are not in complete remission (CR) after the 2nd course, they will go off protocol. Patients in CR after reinduction treatment can immediately proceed to stem cell transplantation. Consolidation chemotherapy should be given if SCT is delayed. A 3rd course of intensive chemotherapy (VP16 and continuous infusion with cytarabine) is the general recommendation. In selected patients, a low intensity consolidation may be preferred, and such a schedule is described as well. The type of SCT is based on the risk-group. Preferably, a matched sibling donor (MSD) SCT is performed. If a MSD is not available all patients are candidates for a matched unrelated donor (MUD) SCT. If a MUD is also not available, patients with primary refractory disease, early relapse (within 1 year from diagnosis), or greater than or equal to 2nd relapse, are candidates for the more experimental haplo-identical donor (HID) SCT in view of the dismal prognosis. However, patients with a late relapse (>1 year from initial diagnosis) have a better prognosis and should be offered an autologous SCT if a MSD or MUD SCT is not possible. Only in case of autologous SCT, maintenance treatment and/or adjuvant immunotherapy could be considered.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey Rubnitz, M.D. | 1-866-278-5833 | jeffrey.rubnitz@stjude.org |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Jeffrey Rubnitz, M.D. 866-278-5833 info@stjude.org |
Principal Investigator: | Jeffrey Rubnitz, M.D. | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Researh Hospital ( Jeffrey Rubnitz, MD / Principal Investigator ) |
Study ID Numbers: | TRIAL, TRIAL Relapsed AML 2001/01 |
Study First Received: | September 12, 2005 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00186966 History of Changes |
Health Authority: | United States: Institutional Review Board |
Antimetabolites Daunorubicin Melphalan Immunologic Factors Thioguanine Leukemia, Myeloid Cyclophosphamide Fludarabine monophosphate Leukemia, Myeloid, Acute Immunosuppressive Agents Etoposide phosphate |
Anti-Bacterial Agents Leukemia Acute Myelocytic Leukemia Busulfan Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Alkylating Agents Etoposide Cytarabine |
Antimetabolites Daunorubicin Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Thioguanine Physiological Effects of Drugs Leukemia, Myeloid Cyclophosphamide Antibiotics, Antineoplastic |
Leukemia, Myeloid, Acute Immunosuppressive Agents Pharmacologic Actions Leukemia Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Alkylating Agents |