Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253513
Status:
COMPLETED
Last Update Posted:
2012-06-01
First Post:
2005-11-11
Brief Title:
Treosulfan and Fludarabine in Treating Younger Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Study of a Reduced-Intensity Conditioning Regimen With Treosulfan and Fludarabine for Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2011-02
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 treosulfan and fludarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving treosulfan and fludarabine together with a donor bone marrow transplant or a peripheral stem cell transplant may be an effective treatment for acute myeloid leukemia acute lymphoblastic leukemia or myelodysplastic syndrome
PURPOSE This phase II trial is studying giving treosulfan together with fludarabine to see how well it works in treating patients who are undergoing a donor stem cell transplant for acute myeloid leukemia acute lymphoblastic leukemia or myelodysplastic syndrome
PURPOSE This phase II trial is studying giving treosulfan together with fludarabine to see how well it works in treating patients who are undergoing a donor stem cell transplant for acute myeloid leukemia acute lymphoblastic leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Primary Phase
Determine the best dose of treosulfan when administered with fludarabine as a reduced-intensity conditioning regimen followed by allogeneic hematopoietic stem cell transplantation in terms of incidence of severe to fatal toxicity to major organ systems and incidence of graft failure in patients with acute myeloid leukemia lymphoblastic leukemia or myelodysplastic syndrome
Secondary Phase
Determine the safety of this regimen in terms of incidence of grade II-IV acute and chronic graft-versus-host disease in these patients
Determine preliminarily the efficacy of this regimen in terms of incidence of relapse overall and disease-free survival donor chimerism on days 28 and 100 and incidence of 200-day and 1-year nonrelapse mortality in these patients
Determine the pharmacokinetic and pharmacodynamic profile of treosulfan in patients treated with this regimen
OUTLINE This is a multicenter dose-finding study of treosulfan
Reduced-intensity conditioning Patients receive treosulfan IV over 2 hours on days -6 to -4 and fludarabine IV over 30 minutes on days -6 to -2
Cohorts of 5-10 patients receive escalatingde-escalating doses of treosulfan until the best dose is determined among the 3 pre-selected doses The best dose is defined as the dose preceding that at which 4 of 10 patients experience dose-limiting toxicity
Allogeneic hematopoietic cell transplantation AHCT Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0
All male patients with acute lymphoblastic leukemia OR male patients with acute myeloid leukemia who have prior or current testicular involvement receive external-beam radiotherapy to the testicles before AHCT
After completion of study treatment patents are followed periodically
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Primary Phase
Determine the best dose of treosulfan when administered with fludarabine as a reduced-intensity conditioning regimen followed by allogeneic hematopoietic stem cell transplantation in terms of incidence of severe to fatal toxicity to major organ systems and incidence of graft failure in patients with acute myeloid leukemia lymphoblastic leukemia or myelodysplastic syndrome
Secondary Phase
Determine the safety of this regimen in terms of incidence of grade II-IV acute and chronic graft-versus-host disease in these patients
Determine preliminarily the efficacy of this regimen in terms of incidence of relapse overall and disease-free survival donor chimerism on days 28 and 100 and incidence of 200-day and 1-year nonrelapse mortality in these patients
Determine the pharmacokinetic and pharmacodynamic profile of treosulfan in patients treated with this regimen
OUTLINE This is a multicenter dose-finding study of treosulfan
Reduced-intensity conditioning Patients receive treosulfan IV over 2 hours on days -6 to -4 and fludarabine IV over 30 minutes on days -6 to -2
Cohorts of 5-10 patients receive escalatingde-escalating doses of treosulfan until the best dose is determined among the 3 pre-selected doses The best dose is defined as the dose preceding that at which 4 of 10 patients experience dose-limiting toxicity
Allogeneic hematopoietic cell transplantation AHCT Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0
All male patients with acute lymphoblastic leukemia OR male patients with acute myeloid leukemia who have prior or current testicular involvement receive external-beam radiotherapy to the testicles before AHCT
After completion of study treatment patents are followed periodically
PROJECTED ACCRUAL A total of 60 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 |
|---|---|---|---|
| FHCRC-193100 | None | None | None |
| MEDAC-FHCRC-193100 | None | None | None |
| OHSU-HEM-05107-LM | None | None | None |
| 1765 | OTHER | OHSU IRB | None |