Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002785
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Bone Marrow Transplantation and Radiation Therapy in Treating Infants With Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Infants Less Than 1 Year of Age
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells Radiation therapy uses high-energy x-rays to damage cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy bone marrow transplantation and radiation therapy in treating infants with acute lymphoblastic leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy bone marrow transplantation and radiation therapy in treating infants with acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES I Assess the feasibility and outcome of intensified inductionconsolidation followed by intensified re-inductionre-intensification in infants less than 1 year of age with newly diagnosed acute lymphocytic leukemia ALL II Evaluate the feasibility and outcome of bone marrow transplantation using family or unrelated donors in infants with the 11q23 abnormality III Evaluate neuropsychologic outcome upon completion of protocol therapy in patients who have reached the ages of 3 and 7 years with special attention to the outcome in infants who received total-body irradiation IV Study the biology of infant ALL in samples of leukemic blood and bone marrow V Study the possible associations among patient- and disease-specific factors and family sociodemographic characteristics that mediate treatment outcome
OUTLINE Upon completion of InductionIntensification and Re-Induction therapy patients with the 11q23 abnormality and with a matched or one-antigen mismatched related or unrelated donor proceed immediately to Transplantation all others proceed to Re-Intensification Consolidation Intensified Maintenance and Routine Maintenance The following acronyms are used AlBM Allogeneic Bone Marrow ARA-C Cytarabine NSC-63878 ASP Asparaginase NSC-109229 CF Leucovorin calcium NSC-3590 CTX Cyclophosphamide NSC-26271 CYSP Cyclosporine NSC-290193 DM Dexamethasone NSC-34521 DNR Daunorubicin NSC-82151 G-CSF Granulocyte-Colony Stimulating Factor Amgen NSC-614629 HC Hydrocortisone NSC-10483 MePRDL Methylprednisolone NSC-19987 Mesna Mercaptoethane sulfonate NSC-113891 MP Mercaptopurine NSC-755 MTX Methotrexate NSC-740 PEG-ASP Pegaspargase NSC-644954 PRED Prednisone NSC-10023 TBI Total-Body Irradiation TIT Triple Intrathecal Therapy IT ARA-CIT HCIT MTX VCR Vincristine NSC-67574 VH Very High Dose VP-16 Etoposide NSC-141540 INDUCTIONINTENSIFICATION 5-Drug Combination Systemic Chemotherapy followed by 3-Drug Combination Systemic Chemotherapy plus 3-Drug Combination Intrathecal Chemotherapy DMVCRDNRCTXMesnaASP followed by MTXCFVP-16CTXMesna plus TIT RE-INDUCTION 5-Drug Combination Systemic Chemotherapy plus 3-Drug Combination Intrathecal Chemotherapy DNRVCRCTXMesnaASPDM plus TIT RE-INTENSIFICATION 2-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy followed by 2-Drug Combination Systemic Chemotherapy VCRVH MTXCF plus IT ARA-C followed by VP-16CTXMesna CONSOLIDATION 2-Drug Combination Systemic Chemotherapy followed by 2-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy ARA-CASP followed by VH MTXCFVCR plus IT ARA-C INTENSIFIED MAINTENANCE 4-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy followed by 2-Drug Combination Systemic Chemotherapy DMVCRMTXMP plus IT ARA-C followed by VP-16CTXMesna ROUTINE MAINTENANCE 4-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy VCRMTXMPPRED plus IT MTX TRANSPLANTATION 2-Drug Combination Myeloablative Chemotherapy followed by Radiotherapy followed by Hematopoietic Rescue plus GVHD Prophylaxis ARA-CCTX followed by TBI using a linear accelerator or Co60 equipment followed by AlBM plus MePRDL CYSP
PROJECTED ACCRUAL 100 patients per year will be entered over approximately 3 years
OUTLINE Upon completion of InductionIntensification and Re-Induction therapy patients with the 11q23 abnormality and with a matched or one-antigen mismatched related or unrelated donor proceed immediately to Transplantation all others proceed to Re-Intensification Consolidation Intensified Maintenance and Routine Maintenance The following acronyms are used AlBM Allogeneic Bone Marrow ARA-C Cytarabine NSC-63878 ASP Asparaginase NSC-109229 CF Leucovorin calcium NSC-3590 CTX Cyclophosphamide NSC-26271 CYSP Cyclosporine NSC-290193 DM Dexamethasone NSC-34521 DNR Daunorubicin NSC-82151 G-CSF Granulocyte-Colony Stimulating Factor Amgen NSC-614629 HC Hydrocortisone NSC-10483 MePRDL Methylprednisolone NSC-19987 Mesna Mercaptoethane sulfonate NSC-113891 MP Mercaptopurine NSC-755 MTX Methotrexate NSC-740 PEG-ASP Pegaspargase NSC-644954 PRED Prednisone NSC-10023 TBI Total-Body Irradiation TIT Triple Intrathecal Therapy IT ARA-CIT HCIT MTX VCR Vincristine NSC-67574 VH Very High Dose VP-16 Etoposide NSC-141540 INDUCTIONINTENSIFICATION 5-Drug Combination Systemic Chemotherapy followed by 3-Drug Combination Systemic Chemotherapy plus 3-Drug Combination Intrathecal Chemotherapy DMVCRDNRCTXMesnaASP followed by MTXCFVP-16CTXMesna plus TIT RE-INDUCTION 5-Drug Combination Systemic Chemotherapy plus 3-Drug Combination Intrathecal Chemotherapy DNRVCRCTXMesnaASPDM plus TIT RE-INTENSIFICATION 2-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy followed by 2-Drug Combination Systemic Chemotherapy VCRVH MTXCF plus IT ARA-C followed by VP-16CTXMesna CONSOLIDATION 2-Drug Combination Systemic Chemotherapy followed by 2-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy ARA-CASP followed by VH MTXCFVCR plus IT ARA-C INTENSIFIED MAINTENANCE 4-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy followed by 2-Drug Combination Systemic Chemotherapy DMVCRMTXMP plus IT ARA-C followed by VP-16CTXMesna ROUTINE MAINTENANCE 4-Drug Combination Systemic Chemotherapy plus Single-Agent Intrathecal Chemotherapy VCRMTXMPPRED plus IT MTX TRANSPLANTATION 2-Drug Combination Myeloablative Chemotherapy followed by Radiotherapy followed by Hematopoietic Rescue plus GVHD Prophylaxis ARA-CCTX followed by TBI using a linear accelerator or Co60 equipment followed by AlBM plus MePRDL CYSP
PROJECTED ACCRUAL 100 patients per year will be entered over approximately 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000064841 | OTHER | Clinical Trialsgov | None |
| CCG-1953 | OTHER | None | None |