Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003148
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study of the Efficacy of rH Interleukin-2 in Patients With Slowly Progressing Acute Myelogenous Leukemia AML and With Limited Bone Marrow Blastosis After Autologous Stem Cell Transplantation or Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-06
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 Interleukin-2 may stimulate a persons white blood cells to kill acute myelogenous leukemia cells
PURPOSE Phase II trial to study the effectiveness of interleukin-2 in treating patients with acute myelogenous leukemia that has relapsed following previous treatment
PURPOSE Phase II trial to study the effectiveness of interleukin-2 in treating patients with acute myelogenous leukemia that has relapsed following previous treatment
Detailed Description:
OBJECTIVES I Assess the therapeutic activity of interleukin-2 IL-2 in patients with slowly progressing acute myeloid leukemia with limited bone marrow blastosis either in first relapse after autologous bone marrow or peripheral blood stem cell transplantation or with more advanced disease ie refractory to chemotherapy regimens II Characterize the acute side effects of IL-2 in these patients
OUTLINE This is an open label nonrandomized multicenter study Patients are stratified into two categories of prior failed treatments first relapse after autologous bone marrow or peripheral blood stem cell transplantation vs first or subsequent relapse either refractory to or not eligible for further conventional treatment Interleukin-2 IL-2 is administered as a continuous intravenous infusion on 5 consecutive days at daily escalating doses for the first cycle When the individual maximum tolerated dose MTD has been determined 3 more cycles are given at the MTD There are 3 days of rest between each treatment cycle After the induction phase maintenance cycles of IL-2 are administered starting 4 weeks after the last induction treatment Maintenance cycles of IL-2 are administered subcutaneously on 5 consecutive days every 4 weeks for 2 years and subsequently every other month for a maximum of 3 years Treatment continues until disease progression or unacceptable toxicity for a maximum of 5 years Patients are followed every 4 weeks during the first 2 years then every 8 weeks during the next 3 years or until documented progression and then every 3 months until death
PROJECTED ACCRUAL A maximum of 86 57 transplanted 29 patients nontransplanted patients will be accrued into this study within 2 years
OUTLINE This is an open label nonrandomized multicenter study Patients are stratified into two categories of prior failed treatments first relapse after autologous bone marrow or peripheral blood stem cell transplantation vs first or subsequent relapse either refractory to or not eligible for further conventional treatment Interleukin-2 IL-2 is administered as a continuous intravenous infusion on 5 consecutive days at daily escalating doses for the first cycle When the individual maximum tolerated dose MTD has been determined 3 more cycles are given at the MTD There are 3 days of rest between each treatment cycle After the induction phase maintenance cycles of IL-2 are administered starting 4 weeks after the last induction treatment Maintenance cycles of IL-2 are administered subcutaneously on 5 consecutive days every 4 weeks for 2 years and subsequently every other month for a maximum of 3 years Treatment continues until disease progression or unacceptable toxicity for a maximum of 5 years Patients are followed every 4 weeks during the first 2 years then every 8 weeks during the next 3 years or until documented progression and then every 3 months until death
PROJECTED ACCRUAL A maximum of 86 57 transplanted 29 patients nontransplanted patients will be accrued into this study within 2 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 |
|---|---|---|---|
| EORTC-06964 | None | None | None |