Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003239
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-11-01
Brief Title:
Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Therapy of Early Chronic Phase Chronic Myelogenous Leukemia CML With Alpha Interferon IFN-A Low-Dose Cytosine Arabinoside ARA-C and Homoharringtonine HHT
Status:
COMPLETED
Status Verified Date:
2012-07
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 biological therapy with chemotherapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy with cytarabine and homoharringtonine and biological therapy with interferon alfa in treating patients with chronic phase chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of chemotherapy with cytarabine and homoharringtonine and biological therapy with interferon alfa in treating patients with chronic phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the effectiveness of low dose cytarabine homoharringtonine and interferon alfa in stimulating a complete cytogenic response in patients with Philadelphia chromosome positive early chronic phase chronic myelogenous leukemia II Evaluate the duration of the cytogenic response in these patients after this treatment III Determine differential success rates and analyze results by prognostic subsets eg risk group splenomegaly thrombocytosis age etc in this patient population
OUTLINE Patients receive debulking therapy consisting of hydroxyurea until blood count is at proper level Patients then receive interferon alfa and cytarabine daily by subcutaneous injection Homoharringtonine is administered by continuous infusion on days 1-5 Treatment continues for 5-7 years in the absence of unacceptable toxicity or disease progression accelerated or blastic phase CML If complete remission is achieved peripheral blood stem cells are collected Patients are followed every 3 months for the first year and every 6 months thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 3 years
OUTLINE Patients receive debulking therapy consisting of hydroxyurea until blood count is at proper level Patients then receive interferon alfa and cytarabine daily by subcutaneous injection Homoharringtonine is administered by continuous infusion on days 1-5 Treatment continues for 5-7 years in the absence of unacceptable toxicity or disease progression accelerated or blastic phase CML If complete remission is achieved peripheral blood stem cells are collected Patients are followed every 3 months for the first year and every 6 months thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000066114 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| U01CA070172 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-DM-97229 | OTHER | None | None |
| MDA-FDR001791 | None | None | None |
| NCI-T97-0105 | None | None | None |