Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002609
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy and Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia in Remission
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
PHASE II TRIAL OF POST-REMISSION THERAPY WITH HuM195 AND CYTOTOXIC CHEMOTHERAPY FOR ACUTE PROMYELOCYTIC LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2013-06
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 Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus monoclonal antibody therapy in treating patients with acute promyelocytic leukemia in remission
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus monoclonal antibody therapy in treating patients with acute promyelocytic leukemia in remission
Detailed Description:
OBJECTIVES I Evaluate the antileukemic effects of humanized anti-CD33 monoclonal antibody M195 HuM195 against minimal residual disease in patients with acute promyelocytic leukemia APL by using a reverse transcription-polymerase chain reaction for the mutated retinoic acid receptor-alpha to detect changes in minimal residual disease II Assess the disease free and overall survival of patients with APL receiving HuM195 for minimal residual disease III Evaluate the safety and toxicity of HuM195 in these patients IV Evaluate whether HuM195 elicits a human anti-human antibody response including anti-idiotype antibody responses in patients with APL
OUTLINE Patients continue retinoid therapy until 30 days after documentation of clinical complete remission Patients begin treatment within 10 days of documentation of clinical complete remission or after RT-PCR-confirmed molecular relapse or 3-6 weeks after chemotherapy Patients receive HuM195 IV over 60 minutes twice a week for 6 doses Patients with unacceptable toxicity in first complete remission or ineligible for bone marrow transplant BMT proceed to the next regimen Patients receive idarubicin IV over 15 minutes on days 1-3 and cytarabine IV continuously over days 1-5 Patients then receive 2 more courses given at 4-6 week intervals consisting of idarubicin IV over 15 minutes on days 1-2 and cytarabine IV continuously on days 1-4 Patients begin maintenance therapy after toxicity resolves or 1 week after the last dose of HuM195 This consists of HuM195 IV over 60 minutes for 2 doses 72-96 hours apart Treatment repeats once a month for 6 courses Patients who have an initial molecular response but are positive on the RT-PCR assay or who achieve complete remission following clinical relapse of disease during treatment are eligible for retreatment Patients are followed every 3 months
PROJECTED ACCRUAL A total of 14-40 patients will be accrued for this study over 2-3 years
OUTLINE Patients continue retinoid therapy until 30 days after documentation of clinical complete remission Patients begin treatment within 10 days of documentation of clinical complete remission or after RT-PCR-confirmed molecular relapse or 3-6 weeks after chemotherapy Patients receive HuM195 IV over 60 minutes twice a week for 6 doses Patients with unacceptable toxicity in first complete remission or ineligible for bone marrow transplant BMT proceed to the next regimen Patients receive idarubicin IV over 15 minutes on days 1-3 and cytarabine IV continuously over days 1-5 Patients then receive 2 more courses given at 4-6 week intervals consisting of idarubicin IV over 15 minutes on days 1-2 and cytarabine IV continuously on days 1-4 Patients begin maintenance therapy after toxicity resolves or 1 week after the last dose of HuM195 This consists of HuM195 IV over 60 minutes for 2 doses 72-96 hours apart Treatment repeats once a month for 6 courses Patients who have an initial molecular response but are positive on the RT-PCR assay or who achieve complete remission following clinical relapse of disease during treatment are eligible for retreatment Patients are followed every 3 months
PROJECTED ACCRUAL A total of 14-40 patients will be accrued for this study over 2-3 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 |
|---|---|---|---|
| NCI-H94-0571 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000063898 | REGISTRY | None | None |