Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112554
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2005-06-02
Brief Title:
Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Randomized of Cloretazine VNP40101M and Cytosine Arabinoside AraC in Patients With Acute Myeloid Leukemia in First Relapse
Status:
COMPLETED
Status Verified Date:
2009-02
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 Drugs used in chemotherapy such as cytarabine and VNP40101M work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells
PURPOSE This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia
PURPOSE This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Compare the complete response CR and CR with platelet count 100000mm3 but 20000mm3 transfusion independent for 7 consecutive days CRp rates in patients with acute myeloid leukemia in first relapse treated with cytarabine with vs without VNP40101M
Secondary
Compare time to progression in patients treated with these regimens
Compare duration of response in patients treated with these regimens
Compare the survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled parallel group multicenter study Patients are stratified according to age 60 years vs 60 years and duration of first complete response CR or CR with platelet count 100000mm³ but 20000mm³ transfusion independent for 7 consecutive days CRp 12 months vs 12 months
Induction therapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 at least 12 hours after the start of cytarabine
Arm II Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 at least 12 hours after the start of cytarabine
In both arms patients demonstrating at least 20 reduction of blasts in bone marrow based on total cellularity and percent blasts after course 1 may receive 1 additional course of induction therapy between days 35-60 in the absence of disease progression or unacceptable toxicity Patients achieving CR or CRp after 1 or 2 courses of induction therapy proceed to consolidation therapy
Consolidation therapy Beginning 6 weeks after initial documentation of CR or CRp patients receive 1 course of consolidation therapy as per induction therapy according to their randomized treatment arm These patients may then proceed to other consolidation maintenance andor intensification therapy including stem cell transplantation off study at the discretion of the physician
After completion of study treatment patients are followed monthly for 6 months every 2 months for 6 months and then every 3 months for 2 years
PROJECTED ACCRUAL A total of 420 patients 280 in arm I and 140 in arm II will be accrued for this study within 24-30 months
Primary
Compare the complete response CR and CR with platelet count 100000mm3 but 20000mm3 transfusion independent for 7 consecutive days CRp rates in patients with acute myeloid leukemia in first relapse treated with cytarabine with vs without VNP40101M
Secondary
Compare time to progression in patients treated with these regimens
Compare duration of response in patients treated with these regimens
Compare the survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled parallel group multicenter study Patients are stratified according to age 60 years vs 60 years and duration of first complete response CR or CR with platelet count 100000mm³ but 20000mm³ transfusion independent for 7 consecutive days CRp 12 months vs 12 months
Induction therapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 at least 12 hours after the start of cytarabine
Arm II Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 at least 12 hours after the start of cytarabine
In both arms patients demonstrating at least 20 reduction of blasts in bone marrow based on total cellularity and percent blasts after course 1 may receive 1 additional course of induction therapy between days 35-60 in the absence of disease progression or unacceptable toxicity Patients achieving CR or CRp after 1 or 2 courses of induction therapy proceed to consolidation therapy
Consolidation therapy Beginning 6 weeks after initial documentation of CR or CRp patients receive 1 course of consolidation therapy as per induction therapy according to their randomized treatment arm These patients may then proceed to other consolidation maintenance andor intensification therapy including stem cell transplantation off study at the discretion of the physician
After completion of study treatment patients are followed monthly for 6 months every 2 months for 6 months and then every 3 months for 2 years
PROJECTED ACCRUAL A total of 420 patients 280 in arm I and 140 in arm II will be accrued for this study within 24-30 months
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 |
|---|---|---|---|
| VION-CLI-037 | None | None | None |