Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002499
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Relapsed Acute Lymphocytic Leukemia
Sponsor:
Grupo Argentino de Tratamiento de la Leucemia Aguda
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
TREATMENT OF ALL IN FIRST BONE MARROW RELAPSE AFTER BFM PROTOCOLS
Status:
UNKNOWN
Status Verified Date:
2000-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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
PURPOSE Phase IIIII trial to study the effectiveness of combination chemotherapy in treating children with relapsed acute lymphocytic leukemia
PURPOSE Phase IIIII trial to study the effectiveness of combination chemotherapy in treating children with relapsed acute lymphocytic leukemia
Detailed Description:
OBJECTIVES I Evaluate the feasibility at GATLA of a study of the treatment of ALL in first hematologic relapse following treatment on a BFM protocol II Evaluate the efficacy of induction with vincristinedaunorubicinasparaginaseprednisone in producing a second complete remission in these patients and evaluate the toxicity of this regimen III Evaluate the efficacy and toxicity of the Capizzi I regimen vincristineasparaginasemethotrexate and Capizzi II regimen cytarabineasparaginasedaunorubicin when given to maintain and prolong complete remission IV Offer the option of bone marrow transplantation to those patients who are in second remission and who have a histocompatible donor and compare outcome of these patients with those on chemotherapy alone
OUTLINE Nonrandomized study Patients achieving remission on Induction proceed to Interim Maintenance then to Continued Maintenance those failing to achieve remission receive Salvage Re-induction followed if remission is achieved by Interim Maintenance then Continued Maintenance Induction 4-Drug Combination Chemotherapy with CNS ProphylaxisTherapy Vincristine VCR NSC-67574 Prednisone PRED NSC-10023 Asparaginase ASP NSC-109229 Daunorubicin DNR NSC-82151 with Intrathecal Cytarabine IT ARA-C NSC-63878 Intrathecal Dexamethasone IT DM NSC-34521 Interim Maintenance 3-Drug Combination Chemotherapy with as indicated Radiotherapy VCR ASP Methotrexate MTX NSC-740 with as indicated testicular irradiation equipment not specified Continued Maintenance 3-Drug Combination Chemotherapy followed by 3-Drug Combination Chemotherapy with CNS Prophylaxis and as indicated Radiotherapy Capizzi II ARA-C ASP DNR followed by Capizzi I VCR ASP MTX with IT ARA-C IT DM and as indicated cranial irradiation equipment not specified Salvage Re-induction 2-Drug Combination Chemotherapy ARA-C ASP
PROJECTED ACCRUAL At least 72 evaluable patients will be entered Accrual is expected to be completed in 3 years
OUTLINE Nonrandomized study Patients achieving remission on Induction proceed to Interim Maintenance then to Continued Maintenance those failing to achieve remission receive Salvage Re-induction followed if remission is achieved by Interim Maintenance then Continued Maintenance Induction 4-Drug Combination Chemotherapy with CNS ProphylaxisTherapy Vincristine VCR NSC-67574 Prednisone PRED NSC-10023 Asparaginase ASP NSC-109229 Daunorubicin DNR NSC-82151 with Intrathecal Cytarabine IT ARA-C NSC-63878 Intrathecal Dexamethasone IT DM NSC-34521 Interim Maintenance 3-Drug Combination Chemotherapy with as indicated Radiotherapy VCR ASP Methotrexate MTX NSC-740 with as indicated testicular irradiation equipment not specified Continued Maintenance 3-Drug Combination Chemotherapy followed by 3-Drug Combination Chemotherapy with CNS Prophylaxis and as indicated Radiotherapy Capizzi II ARA-C ASP DNR followed by Capizzi I VCR ASP MTX with IT ARA-C IT DM and as indicated cranial irradiation equipment not specified Salvage Re-induction 2-Drug Combination Chemotherapy ARA-C ASP
PROJECTED ACCRUAL At least 72 evaluable patients will be entered Accrual is expected to be completed in 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 |
|---|---|---|---|
| NCI-F92-0006 | None | None | None |
| ARG-GATLA-1LLAREC90 | None | None | None |