Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070174
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2003-10-03
Brief Title:
Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia AML Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin GMTZ A COG Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-02
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 Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells It also helps stop the patients immune system from rejecting the donors stem cells Also monoclonal antibodies such as gemtuzumab ozogamicin can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets
PURPOSE This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction intensification therapy and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia
PURPOSE This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction intensification therapy and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the safety of gemtuzumab ozogamicin in children with newly diagnosed acute myeloid leukemia undergoing intensive remission induction and intensification therapy
Determine the complete remission rate of patients treated with this regimen
Secondary
Determine the feasibility of performing biological studies eg FLT3-ITD and MRD for risk group stratification in these patients
Determine the effect of karyotypic abnormalities on survival in patients treated with this regimen
OUTLINE This is a multicenter study
Induction I Patients receive high-dose cytarabine ARA-C IV twice daily on days 1-10 daunorubicin IV over 6 hours on days 1 3 and 5 etoposide IV over 4 hours on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on day 6 Patients with CNS-negative disease receive ARA-C intrathecally IT on day 1 Patients with CNS-positive disease receive ARA-C IT twice weekly for 2-3 weeks Between days 28-35 patients are evaluated Patients achieving remission or who have no more than 20 blasts proceed to induction II
Induction II Patients receive ARA-C IV twice daily on days 1-8 ARA-C IT on day 1 and daunorubicin IV and etoposide IV as in induction I Between days 28-35 patients are evaluated Patients achieving complete remission proceed to intensification course I
Intensification course I Patients receive ARA-C IV over 1 hour twice daily on days 1-5 ARA-C IT as in induction II and etoposide IV over 1 hour on days 1-5 Patients are evaluated at day 28 Patients with a 56 or 66 matched family donor proceed to allogeneic bone marrow transplantation All other patients in complete remission proceed to intensification course II
Intensification course II Patients receive ARA-C IV over 2 hours twice daily on days 1-4 ARA-C IT as in induction II mitoxantrone IV over 1 hour on days 3-6 and gemtuzumab ozogamicin IV over 2 hours on day 7 Patients are evaluated on day 28 and then proceed to intensification course III
Intensification course III Patients receive ARA-C IV over 3 hours twice daily on days 1 2 8 and 9 and asparaginase intramuscularly on days 2 and 9
Allogeneic bone marrow transplantation Patients receive a preparative regimen comprising busulfan IV over 2 hours 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour once daily on days -5 to -2 Allogeneic stem cells are infused on day 0
Graft-versus-host disease prophylaxis Patients receive oral or IV cyclosporine twice daily on days -1 to 50 and methotrexate IV once daily on days 1 3 6 and 11
In all courses treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 6 months every 2 months for 6 months every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 330 patients will be accrued for this study
Primary
Determine the safety of gemtuzumab ozogamicin in children with newly diagnosed acute myeloid leukemia undergoing intensive remission induction and intensification therapy
Determine the complete remission rate of patients treated with this regimen
Secondary
Determine the feasibility of performing biological studies eg FLT3-ITD and MRD for risk group stratification in these patients
Determine the effect of karyotypic abnormalities on survival in patients treated with this regimen
OUTLINE This is a multicenter study
Induction I Patients receive high-dose cytarabine ARA-C IV twice daily on days 1-10 daunorubicin IV over 6 hours on days 1 3 and 5 etoposide IV over 4 hours on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on day 6 Patients with CNS-negative disease receive ARA-C intrathecally IT on day 1 Patients with CNS-positive disease receive ARA-C IT twice weekly for 2-3 weeks Between days 28-35 patients are evaluated Patients achieving remission or who have no more than 20 blasts proceed to induction II
Induction II Patients receive ARA-C IV twice daily on days 1-8 ARA-C IT on day 1 and daunorubicin IV and etoposide IV as in induction I Between days 28-35 patients are evaluated Patients achieving complete remission proceed to intensification course I
Intensification course I Patients receive ARA-C IV over 1 hour twice daily on days 1-5 ARA-C IT as in induction II and etoposide IV over 1 hour on days 1-5 Patients are evaluated at day 28 Patients with a 56 or 66 matched family donor proceed to allogeneic bone marrow transplantation All other patients in complete remission proceed to intensification course II
Intensification course II Patients receive ARA-C IV over 2 hours twice daily on days 1-4 ARA-C IT as in induction II mitoxantrone IV over 1 hour on days 3-6 and gemtuzumab ozogamicin IV over 2 hours on day 7 Patients are evaluated on day 28 and then proceed to intensification course III
Intensification course III Patients receive ARA-C IV over 3 hours twice daily on days 1 2 8 and 9 and asparaginase intramuscularly on days 2 and 9
Allogeneic bone marrow transplantation Patients receive a preparative regimen comprising busulfan IV over 2 hours 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour once daily on days -5 to -2 Allogeneic stem cells are infused on day 0
Graft-versus-host disease prophylaxis Patients receive oral or IV cyclosporine twice daily on days -1 to 50 and methotrexate IV once daily on days 1 3 6 and 11
In all courses treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 6 months every 2 months for 6 months every 4 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 330 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 |
|---|---|---|---|
| COG-AAML03P1 | OTHER | Childrens Oncology Group | None |
| CDR0000330133 | OTHER | None | None |