Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002989
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Idarubicin and Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Study to Assess Intensification of the Conditioning Regimen for Allogenic Stem Cell Transplantation ALLO-SCT for Leukemia or Myelodysplastic Syndrome With a High Risk of Relapse
Status:
UNKNOWN
Status Verified Date:
2007-07
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 idarubicin plus peripheral stem cell transplantation using the patients own or donated stem cells in treating patients with leukemia or myelodysplastic syndrome
PURPOSE Randomized phase III trial to compare the effectiveness of idarubicin plus peripheral stem cell transplantation using the patients own or donated stem cells in treating patients with leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Assess the value of idarubicin added to the standard conditioning regimen of allogeneic and autologous stem cell transplantation in patients with leukemia or myelodysplastic syndrome at high risk of relapse II Determine time to recovery of polymorphonuclear neutrophil leukocyte PMN and platelet counts in these patients III Evaluate the rate and type of grade 3-4 toxicity particularly mucositis and the number of days with fever in these patients IV Determine the incidence of acute and chronic graft versus host disease GVHD in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease acute myelogenous leukemia AML vs acute lymphocytic leukemia ALL or lymphoblastic leukemia LL vs myelodysplastic syndrome MDS or secondary AML vs chronic myelogenous leukemia CML vs non-Hodgkins lymphoma vs multiple myeloma stage of disease if not CML 1st complete response CR vs 2nd CR vs no 1st2nd CR if CML 1st CR vs other phases conditioning regimen cyclophosphamide CTX and total body irradiation TBI vs busulfan BU and CTX vs other source of donor allogeneic vs autologous T-cell depletion or autologous transplantation no vs yes and source of stem cells bone marrow vs peripheral blood stem cell Patients are randomized to receive a standard regimen or an intensified regimen Standard pretransplant treatment CTX on days -6 and -5 and TBI on days -4 through -2 or BU on days -8 through -5 and CTX on days -4 and -3 or BU on days -8 through -5 and melphalan IV on day -4 Intensified pretransplant regimens I Continuous infusion of idarubicin IDA over 48 hours on days -12 and -11 followed 5 days later with CTX on days -6 and -5 and TBI on days -4 to -2 II IDA followed 5 days later with BU on days -8 through -5 and then CTX on days -4 and -3 III IDA followed by BU on days -8 through -5 and melphalan IV on day -4 Stem cells are infused on day 0 Patients are followed every 3 months during the first 3 years then every 6 months thereafter
PROJECTED ACCRUAL A total of 207 patients will be accrued for this study within 3 years
OUTLINE This is a randomized multicenter study Patients are stratified according to disease acute myelogenous leukemia AML vs acute lymphocytic leukemia ALL or lymphoblastic leukemia LL vs myelodysplastic syndrome MDS or secondary AML vs chronic myelogenous leukemia CML vs non-Hodgkins lymphoma vs multiple myeloma stage of disease if not CML 1st complete response CR vs 2nd CR vs no 1st2nd CR if CML 1st CR vs other phases conditioning regimen cyclophosphamide CTX and total body irradiation TBI vs busulfan BU and CTX vs other source of donor allogeneic vs autologous T-cell depletion or autologous transplantation no vs yes and source of stem cells bone marrow vs peripheral blood stem cell Patients are randomized to receive a standard regimen or an intensified regimen Standard pretransplant treatment CTX on days -6 and -5 and TBI on days -4 through -2 or BU on days -8 through -5 and CTX on days -4 and -3 or BU on days -8 through -5 and melphalan IV on day -4 Intensified pretransplant regimens I Continuous infusion of idarubicin IDA over 48 hours on days -12 and -11 followed 5 days later with CTX on days -6 and -5 and TBI on days -4 to -2 II IDA followed 5 days later with BU on days -8 through -5 and then CTX on days -4 and -3 III IDA followed by BU on days -8 through -5 and melphalan IV on day -4 Stem cells are infused on day 0 Patients are followed every 3 months during the first 3 years then every 6 months thereafter
PROJECTED ACCRUAL A total of 207 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 |
|---|---|---|---|
| EORTC-06962 | None | None | None |