Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002926
Status:
UNKNOWN
Last Update Posted:
2010-05-27
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Autologous Peripheral Blood Stem Cell Transplantation PSCT Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes MDS and Acute Myelogenous Leukemia Secondary SAML to MDS of More Acute Than 6 Months Duration
Status:
UNKNOWN
Status Verified Date:
2001-05
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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia
Detailed Description:
OBJECTIVES
Assess the value of autologous peripheral stem cell transplantation versus high dose cytarabine Ara-C performed after a common induction and consolidation course in patients with poor prognosis myelodysplastic syndromes MDS or acute myelogenous leukemia secondary to MDS
Compare the disease free survival and overall survival of patients who reached complete recovery according to the presence of an HLA-identical donor
Monitor cytogenetic and clonal remission after intensive antileukemic therapy including stem cell transplantation
Monitor residual disease and the hematopoietic clonal status of autologous peripheral blood stem cells mobilized after one consolidation course
Assess recovery time of granulocyte and platelet counts following each treatment step
OUTLINE Induction treatment with idarubicin on days 135 Ara-C from days 1 through 10 etoposide on days 1 through 5 On day 28 there will be assessment of responses If there is at least partial response the cycle will repeat the induction course for another 28 days There is peripheral blood stem cell collection and cryopreservation following family HLA-typing If there is no HLA match then those who remained in remission after these consolidation courses will be randomized to either peripheral blood stem cell transplantation or HiDAC treatment
PROJECTED ACCRUAL 80 patients will be entered per year
Assess the value of autologous peripheral stem cell transplantation versus high dose cytarabine Ara-C performed after a common induction and consolidation course in patients with poor prognosis myelodysplastic syndromes MDS or acute myelogenous leukemia secondary to MDS
Compare the disease free survival and overall survival of patients who reached complete recovery according to the presence of an HLA-identical donor
Monitor cytogenetic and clonal remission after intensive antileukemic therapy including stem cell transplantation
Monitor residual disease and the hematopoietic clonal status of autologous peripheral blood stem cells mobilized after one consolidation course
Assess recovery time of granulocyte and platelet counts following each treatment step
OUTLINE Induction treatment with idarubicin on days 135 Ara-C from days 1 through 10 etoposide on days 1 through 5 On day 28 there will be assessment of responses If there is at least partial response the cycle will repeat the induction course for another 28 days There is peripheral blood stem cell collection and cryopreservation following family HLA-typing If there is no HLA match then those who remained in remission after these consolidation courses will be randomized to either peripheral blood stem cell transplantation or HiDAC treatment
PROJECTED ACCRUAL 80 patients will be entered per year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-06961 | None | None | None |