Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005802
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2000-06-02
Brief Title:
Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Chemotherapy CT Followed by Donor Lymphocyte Infusion DLI Plus Interleukin 2 IL-2 for Patients With Relapse Acute Myeloid or Lymphoid Leukemia After Allogeneic Hematopoietic Transplant
Status:
COMPLETED
Status Verified Date:
2010-03
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 use different ways to stop cancer cells from dividing so they stop growing or die Interleukin-2 may stimulate a persons white blood cells to kill leukemia cells Treating donor white blood cells with interleukin-2 in the laboratory may help them kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of interleukin-2 when given after chemotherapy and donor white blood cells and to see how well they work in treating patients with acute myeloid leukemia or acute lymphoid leukemia
PURPOSE This phase III trial is studying the side effects and best dose of interleukin-2 when given after chemotherapy and donor white blood cells and to see how well they work in treating patients with acute myeloid leukemia or acute lymphoid leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of interleukin-2 following donor lymphocyte infusion and chemotherapy in patients with relapsed acute myeloid or lymphoid leukemia after allogeneic peripheral blood stem cell transplantation
Determine the toxicity and efficacy of this regimen in these patients
OUTLINE This is a dose escalation study of interleukin-2 IL-2 Patients are stratified according to disease status after chemotherapy acute myeloid leukemia AML in complete remission CR vs acute lymphoid leukemia ALL or AML not in CR
Patients receive one of three induction chemotherapy regimens depending on type of leukemia prior treatment and response
Regimen 1 Patients receive high dose cytarabine IV over 2 hours twice a day on days 1 3 and 5
Regimen 2 Patients receive mitoxantrone IV over 15 minutes and etoposide IV over 30 minutes on days 1-5
Regimen 3 Patients receive fludarabine IV over 30 minutes on days 1-5 cytarabine IV over 2 hours on days 1-4 and filgrastim G-CSF subcutaneously beginning on day 1 and continuing until blood counts recover
Patients with extramedullary relapse receive local radiotherapy Patients with ALL or CNS relapse receive intrathecal methotrexate with or without hydrocortisone and cytarabine
Patients receive one donor lymphocyte infusion IV over 15-30 minutes within 28-60 days after starting chemotherapy On the same day IL-2 IV is administered over 24 hours for 5 days After 2 days rest IL-2 is again administered continuously for 10 days
Cohorts of 5 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 5 patients experience dose limiting toxicities Up to 40 patients are treated at the MTD
Patients are followed monthly for 3 months and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 11-15 patients per year will be accrued for this study
Determine the maximum tolerated dose of interleukin-2 following donor lymphocyte infusion and chemotherapy in patients with relapsed acute myeloid or lymphoid leukemia after allogeneic peripheral blood stem cell transplantation
Determine the toxicity and efficacy of this regimen in these patients
OUTLINE This is a dose escalation study of interleukin-2 IL-2 Patients are stratified according to disease status after chemotherapy acute myeloid leukemia AML in complete remission CR vs acute lymphoid leukemia ALL or AML not in CR
Patients receive one of three induction chemotherapy regimens depending on type of leukemia prior treatment and response
Regimen 1 Patients receive high dose cytarabine IV over 2 hours twice a day on days 1 3 and 5
Regimen 2 Patients receive mitoxantrone IV over 15 minutes and etoposide IV over 30 minutes on days 1-5
Regimen 3 Patients receive fludarabine IV over 30 minutes on days 1-5 cytarabine IV over 2 hours on days 1-4 and filgrastim G-CSF subcutaneously beginning on day 1 and continuing until blood counts recover
Patients with extramedullary relapse receive local radiotherapy Patients with ALL or CNS relapse receive intrathecal methotrexate with or without hydrocortisone and cytarabine
Patients receive one donor lymphocyte infusion IV over 15-30 minutes within 28-60 days after starting chemotherapy On the same day IL-2 IV is administered over 24 hours for 5 days After 2 days rest IL-2 is again administered continuously for 10 days
Cohorts of 5 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 5 patients experience dose limiting toxicities Up to 40 patients are treated at the MTD
Patients are followed monthly for 3 months and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 11-15 patients per year 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 |
|---|---|---|---|
| FHCRC-138000 | None | None | None |
| NCI-H00-0057 | None | None | None |
| CDR0000067777 | REGISTRY | PDQ | None |