Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003407
Status:
WITHDRAWN
Last Update Posted:
2023-02-02
First Post:
1999-11-01
Brief Title:
Amifostine High-Dose Combination Chemotherapy in Treating Patients With Acute ML or CML
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Treatment of Poor Prognosis Acute Myeloid Leukemia and Blastic Crisis Chronic Myelogenous Leukemia With Mylotarg High-Dose Cytarabine Mitozantrone and Ethyol AMLCML 2000-06
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI deceased
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 Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Assess the effects of amifostine on the response to remission induction therapy and consolidation with cytarabine and mitoxantrone in patients with poor prognosis acute myeloid leukemia AML relapsed AML and blastic phase chronic myelogenous leukemia CML II Assess the effects of amifostine on the biology of AML and CML cells in vivo in this patient population
OUTLINE Patients receive treatment prior to induction therapy on protocols CYL 90-03 and CYL 97-59 Induction therapy consists of amifostine IV on days 1 and 5 and three times a week from days 6 to 28 Fifteen minutes after amifostine on days 1 and 5 patients receive cytarabine IV over 3 hours at hour 0 and hour 12 and mitoxantrone IV over 1 hour at hour 15 Patients who do not enter remission receive a second course of induction therapy Patients with persistent AML following a second course are removed from the study Patients who achieve a complete response CR clinical CR or remission in bone marrow but without hematologic recovery or who return to myelodysplastic syndrome receive consolidation therapy Consolidation therapy consists of amifostine IV on days 1 and 5 and then three times a week until blood counts recover or day 30 whichever comes first Patients also receive cytarabine and mitoxantrone as in induction therapy Patients receive a second course of consolidation therapy beginning 1 week after blood counts recover After completion of consolidation therapy patients are enrolled on protocol MDS 97-53
PROJECTED ACCRUAL A maximum of 50 patients will be accrued for this study
OUTLINE Patients receive treatment prior to induction therapy on protocols CYL 90-03 and CYL 97-59 Induction therapy consists of amifostine IV on days 1 and 5 and three times a week from days 6 to 28 Fifteen minutes after amifostine on days 1 and 5 patients receive cytarabine IV over 3 hours at hour 0 and hour 12 and mitoxantrone IV over 1 hour at hour 15 Patients who do not enter remission receive a second course of induction therapy Patients with persistent AML following a second course are removed from the study Patients who achieve a complete response CR clinical CR or remission in bone marrow but without hematologic recovery or who return to myelodysplastic syndrome receive consolidation therapy Consolidation therapy consists of amifostine IV on days 1 and 5 and then three times a week until blood counts recover or day 30 whichever comes first Patients also receive cytarabine and mitoxantrone as in induction therapy Patients receive a second course of consolidation therapy beginning 1 week after blood counts recover After completion of consolidation therapy patients are enrolled on protocol MDS 97-53
PROJECTED ACCRUAL A maximum of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| RUSH-AML-9801 | OTHER | Rush University Medical Center | httpsreporternihgovquickSearchP01CA075606 |
| P01CA075606 | NIH | None | None |
| ALZA-RUSH-AML-9801 | REGISTRY | None | None |
| NCI-V98-1447 | OTHER_GRANT | None | None |