Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002800
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
PHASE II STUDY OF HIGH DOSE CYTARABINE COMBINED WITH A SINGLE HIGH DOSE OF IDARUBICIN FOR NEWLY DIAGNOSED PATIENTS WITH AML THE AML-3 PROTOCOL
Status:
COMPLETED
Status Verified Date:
2013-07
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
PURPOSE Phase II trial to study the effectiveness of high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or chronic myelogenous leukemia or myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or chronic myelogenous leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Evaluate the effect of combined intensive induction and postremission therapy with high-dose cytarabine plus a single high dose of idarubicin in patients with previously untreated acute myelogenous leukemia AML II Identify cytogenetic molecular or immunophenotypic markers in AML patients for use in the study of residual disease
OUTLINE All patients receive high dose cytarabine for 5 days and idarubicin on the third day as induction chemotherapy Patients who achieve a complete remission CR proceed to consolidation chemotherapy as follows cytarabine and etoposide for 5 days and for patients aged 60 and under cytarabine for 4 days with idarubicin on the third day Patients eligible for the second consolidation course may have peripheral blood stem cells collected following this regimen Patients with an HLA-compatible donor then proceed to allogeneic bone marrow transplantation while patients over age 60 those with the t821 or inv16 cytogenetic abnormality and those without an HLA-compatible donor receive maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks then monthly for 5 months G-CSF is administered with each chemotherapy regimen Patients are followed for survival
PROJECTED ACCRUAL 60 patients will be entered over 3 years
OUTLINE All patients receive high dose cytarabine for 5 days and idarubicin on the third day as induction chemotherapy Patients who achieve a complete remission CR proceed to consolidation chemotherapy as follows cytarabine and etoposide for 5 days and for patients aged 60 and under cytarabine for 4 days with idarubicin on the third day Patients eligible for the second consolidation course may have peripheral blood stem cells collected following this regimen Patients with an HLA-compatible donor then proceed to allogeneic bone marrow transplantation while patients over age 60 those with the t821 or inv16 cytogenetic abnormality and those without an HLA-compatible donor receive maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks then monthly for 5 months G-CSF is administered with each chemotherapy regimen Patients are followed for survival
PROJECTED ACCRUAL 60 patients will be entered over 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 |
|---|---|---|---|
| CDR0000064897 | REGISTRY | None | None |
| NCI-V96-0941 | Registry Identifier | PDQ Physician Data Query | None |