Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077116
Status:
COMPLETED
Last Update Posted:
2012-07-16
First Post:
2004-02-10
Brief Title:
Idarubicin Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Idarubicin and Ara-C in Combination With Gemtuzumab-Ozogamicin IAGO for Young Untreated Patients Without an HLA Identical Sibling With High Risk MDS or AML Developing After a Preceding Period With MDS During 6 Months Duration A Phase II Study
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 such as idarubicin and cytarabine work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells Giving healthy stem cells from a donor whose blood closely resembles the patients blood will help the patients bone marrow make new stem cells that become red blood cells white blood cells and platelets
PURPOSE This phase II trial is studying how well giving idarubicin and cytarabine together with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome
PURPOSE This phase II trial is studying how well giving idarubicin and cytarabine together with gemtuzumab ozogamicin works in treating patients with previously untreated high-risk myelodysplastic syndrome or acute myeloid leukemia secondary to myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of combining gemtuzumab ozogamicin with idarubicin and cytarabine with or without cyclophosphamide with total body irradiation vs busulfan followed by allogeneic stem cell transplantation in patients with previously untreated high-risk myelodysplastic syndromes MDS or acute myeloid leukemia secondary to MDS
Determine the toxicity profile of this regimen in these patients
Determine the antileukemicanti-MDS activity of this regimen in these patients
Secondary
Determine the hepatotoxicity of this regimen in terms of veno-occlusive disease in these patients
Determine the severity of pancytopenia and duration of recovery in patients treated with this regimen
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 treatment groups
Group 1 for patients with no HLA-matched sibling donor Patients receive remission-induction chemotherapy comprising idarubicin IV over 5 minutes on days 1 3 and 5 cytarabine IV continuously over 24 hours on days 1-10 and gemtuzumab ozogamicin IV over 2 hours on day 7 Treatment continues for a second course in the absence of unacceptable toxicity
Group 2 for patients with an HLA-matched sibling donor Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive myeloablative consolidation chemotherapy comprising cyclophosphamide on days -6 and -5 and total body irradiation twice daily on days -4 to -2
Arm II Patients receive myeloablative consolidation chemotherapy comprising busulfan on days -8 to -5 and cyclophosphamide on days -4 and -3
Patients in both arms may alternatively undergo T-cell depletion andor a reduced-intensity conditioning regimen
Approximately 4-8 weeks after completion of consolidation chemotherapy all patients in group 2 undergo allogeneic bone marrow transplantation or allogeneic peripheral blood stem cell transplantation Patients in group 2 then proceed to remission-induction chemotherapy as in group 1
Patients achieving complete remission are recommended for consolidation therapy off study
Patients are followed monthly for 6 months every 2 months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 28 patients will be accrued for this study within 10 months
Primary
Determine the feasibility of combining gemtuzumab ozogamicin with idarubicin and cytarabine with or without cyclophosphamide with total body irradiation vs busulfan followed by allogeneic stem cell transplantation in patients with previously untreated high-risk myelodysplastic syndromes MDS or acute myeloid leukemia secondary to MDS
Determine the toxicity profile of this regimen in these patients
Determine the antileukemicanti-MDS activity of this regimen in these patients
Secondary
Determine the hepatotoxicity of this regimen in terms of veno-occlusive disease in these patients
Determine the severity of pancytopenia and duration of recovery in patients treated with this regimen
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 treatment groups
Group 1 for patients with no HLA-matched sibling donor Patients receive remission-induction chemotherapy comprising idarubicin IV over 5 minutes on days 1 3 and 5 cytarabine IV continuously over 24 hours on days 1-10 and gemtuzumab ozogamicin IV over 2 hours on day 7 Treatment continues for a second course in the absence of unacceptable toxicity
Group 2 for patients with an HLA-matched sibling donor Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive myeloablative consolidation chemotherapy comprising cyclophosphamide on days -6 and -5 and total body irradiation twice daily on days -4 to -2
Arm II Patients receive myeloablative consolidation chemotherapy comprising busulfan on days -8 to -5 and cyclophosphamide on days -4 and -3
Patients in both arms may alternatively undergo T-cell depletion andor a reduced-intensity conditioning regimen
Approximately 4-8 weeks after completion of consolidation chemotherapy all patients in group 2 undergo allogeneic bone marrow transplantation or allogeneic peripheral blood stem cell transplantation Patients in group 2 then proceed to remission-induction chemotherapy as in group 1
Patients achieving complete remission are recommended for consolidation therapy off study
Patients are followed monthly for 6 months every 2 months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 28 patients will be accrued for this study within 10 months
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-06013 | None | None | None |