Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002471
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Intensive Short-Course Combination Chemotherapy in the Treatment of Newly Diagnosed Patients With Poor-Risk Nonlymphoblastic Lymphoma and Acute B-Lymphoblastic Leukemia and in Patients With Recurrent Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-06
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Improve the survival of children and adolescents with poor-risk nonlymphoblastic lymphoma and acute B-lymphoblastic leukemia using an intensive short-course regimen of combination chemotherapy II Assess the toxicity of the regimen
OUTLINE Nonrandomized study Induction 7-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy TIT Cyclophosphamide CTX NSC-26271 Thiotepa TSPA NSC-6396 Vincristine VCR NSC-67574 Daunorubicin DNR NSC-82151 Dexamethasone DM NSC-34521 Etoposide VP-16 NSC-141540 Methotrexate MTX NSC-740 with Leucovorin calcium Citrovorum Factor CF NSC-3590 plus TIT IT MTX IT Cytarabine IT ARA-C NSC-63878 IT Hydrocortisone IT HC NSC-10483 Consolidation 6-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT ARA-C VP-16 Asparaginase E coli ASP NSC-109229 MTX VCR Methylprednisolone MePRDL NSC-19987 with CF plus TIT Reinduction 7-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT CTX TSPA VCR DNR DM VP-16 MTX with CF plus TIT
PROJECTED ACCRUAL A maximum of 30 patients accrued from 4 institutions will be entered If at any time more than 3 patients are not event free the trial will be terminated early with patients considered event free if they enter remission do not die as a result of treatment toxicity and do not experience progression within 1 year from the start of therapy
OUTLINE Nonrandomized study Induction 7-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy TIT Cyclophosphamide CTX NSC-26271 Thiotepa TSPA NSC-6396 Vincristine VCR NSC-67574 Daunorubicin DNR NSC-82151 Dexamethasone DM NSC-34521 Etoposide VP-16 NSC-141540 Methotrexate MTX NSC-740 with Leucovorin calcium Citrovorum Factor CF NSC-3590 plus TIT IT MTX IT Cytarabine IT ARA-C NSC-63878 IT Hydrocortisone IT HC NSC-10483 Consolidation 6-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT ARA-C VP-16 Asparaginase E coli ASP NSC-109229 MTX VCR Methylprednisolone MePRDL NSC-19987 with CF plus TIT Reinduction 7-Drug Combination Chemotherapy with Leucovorin Rescue plus TIT CTX TSPA VCR DNR DM VP-16 MTX with CF plus TIT
PROJECTED ACCRUAL A maximum of 30 patients accrued from 4 institutions will be entered If at any time more than 3 patients are not event free the trial will be terminated early with patients considered event free if they enter remission do not die as a result of treatment toxicity and do not experience progression within 1 year from the start of therapy
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-V90-0104 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000076672 | REGISTRY | None | None |
| NYU-97-9 | None | None | None |