Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031655
Status:
COMPLETED
Last Update Posted:
2012-12-07
First Post:
2002-03-08
Brief Title:
Reduced Intensity Donor Stem Cell Transplant in Treating Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission
Sponsor:
Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation From HLA Matched Unrelated Donors for Treatment of Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission - A Multicenter Trial
Status:
COMPLETED
Status Verified Date:
2012-12
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:
The reason for doing this study is to determine whether a new method of blood stem cell transplant also known as bone marrow transplant is able to treat acute lymphocytic leukemia Blood stem cells are the seed cells necessary to make all blood cells This new method of transplant uses a combination of low dose radiation and chemotherapy that may be less toxic and cause less harm than a conventional transplant This lower dose transplant is called a nonmyeloablative transplant Researchers want to see if using less radiation and less chemotherapy combined with new immune suppressing drugs after the transplant will help a stem cell transplant to work Researchers hope that this treatment will cure acute lymphocytic leukemia with fewer side effects Researchers are hoping to see a mixture of recipient and donor blood cells after transplant This mixture of donor and recipient blood cells is called mixed chimerism Researchers hope that donor cells will attack and eliminate the leukemia This is called the graft-versus-leukemia effect In addition after the transplant white blood cells from the donor may be given to enhance or boost the graft-versus-leukemia effect and hopefully remove all remaining cancer cells This study is being done because at the present time blood stem cell transplantation or bone marrow transplantation is the only known curative therapy for acute lymphocytic leukemia Because of age or underlying health status acute lymphocytic leukemia patients have a higher likelihood of experiencing severe harm from a conventional blood stem cell transplant Researchers are doing this study to see if this new nonmyeloablative method of low dose radiation and low dose chemotherapy given before transplant and immune suppressive drugs after transplant will help make the transplant safer and also cure acute lymphocytic leukemia
Detailed Description:
PRIMARY OBJECTIVES
I To determine if a one-year disease-free survival DFS of 25 can be achieved among adult patients with high risk acute lymphocytic leukemia ALL in complete remission CR who undergo nonmyeloablative allografting
II To determine if a one-year DFS of 40 can be achieved among pediatric patients with high risk ALL in CR who undergo nonmyeloablative allografting
SECONDARY OBJECTIVES
I To determine if a day 200 transplant-related mortality TRM of 25 can be achieved among patients with high risk ALL in CR who undergo nonmyeloablative allografting
II To evaluate the efficacy and toxicity of donor lymphocyte infusion DLI in the treatment of minimal residue disease MRD after nonmyeloablative allografting for patients with high risk ALL in CR
OUTLINE
NONMYELOALATIVE CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo total body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplantation PBSCT on day 0 Patients with minimal residual disease may receive donor lymphocyte infusion IV
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO every 12 hours on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO very 8 hours on days 0 to 40 with taper to day 96
After completion of study treatment patients are followed up at days 28 56 84 120 180 and 360 at 18 months and annually for up to 5 years
I To determine if a one-year disease-free survival DFS of 25 can be achieved among adult patients with high risk acute lymphocytic leukemia ALL in complete remission CR who undergo nonmyeloablative allografting
II To determine if a one-year DFS of 40 can be achieved among pediatric patients with high risk ALL in CR who undergo nonmyeloablative allografting
SECONDARY OBJECTIVES
I To determine if a day 200 transplant-related mortality TRM of 25 can be achieved among patients with high risk ALL in CR who undergo nonmyeloablative allografting
II To evaluate the efficacy and toxicity of donor lymphocyte infusion DLI in the treatment of minimal residue disease MRD after nonmyeloablative allografting for patients with high risk ALL in CR
OUTLINE
NONMYELOALATIVE CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo total body irradiation TBI on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplantation PBSCT on day 0 Patients with minimal residual disease may receive donor lymphocyte infusion IV
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO every 12 hours on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO very 8 hours on days 0 to 40 with taper to day 96
After completion of study treatment patients are followed up at days 28 56 84 120 180 and 360 at 18 months and annually for up to 5 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 |
|---|---|---|---|
| P01CA018029 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP01CA018029 |
| NCI-2012-00580 | REGISTRY | None | None |