Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028730
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2002-01-04
Brief Title:
Total-Body Irradiation and Chemotherapy Followed By Donor Bone Marrow Transplant in Treating Young Patients With Hematologic Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of T-Cell Depleted Hematopoietic Stem Cell Transplants SBA-E-BM From HLA Compatible Related or Unrelated Donors After a Myeloablative Preparative Regimen of Hyperfractionated TBI Thiotepa and Cyclophosphamide TBIThiocy for Treatment of Patients Less Than or Equal to 18 Years With Lymphohematopoietic Disorders
Status:
COMPLETED
Status Verified Date:
2015-12
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:
RATIONALE Giving chemotherapy and total body irradiation before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving antithymocyte globulin and removing the T cells from the donor cells before transplant may stop this from happening
PURPOSE This phase II trial is studying how well total-body irradiation and chemotherapy followed by T-cell depleted donor bone marrow transplant works in treating young patients with hematologic cancer
PURPOSE This phase II trial is studying how well total-body irradiation and chemotherapy followed by T-cell depleted donor bone marrow transplant works in treating young patients with hematologic cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of hyperfractionated total body irradiation thiotepa and cyclophosphamide followed by T-cell-depleted allogeneic bone marrow transplantation in children with acute myeloid leukemia acute lymphoblastic leukemia chronic myelogenous leukemia non-Hodgkins lymphoma or myelodysplastic syndromes
Correlate the progenitor cell dose and dose of clonable T cells with the incidence and quality of engraftment extent of chimerism incidence and severity of acute and chronic graft-versus-host disease characteristics of hematopoietic and immunologic reconstitution and overall and disease-free survival at 2 years in patients treated with this regimen
OUTLINE Patients undergo total body irradiation three times daily on days -9 to -7 and twice on day -6 Patients receive thiotepa IV over 4 hours on days -5 and -4 and cyclophosphamide IV over 30 minutes on days -3 and -2 Patients who cannot receive cyclophosphamide due to prior hemorrhagic cystitis or exposure to high-dose cyclophosphamide or ifosfamide receive fludarabine IV over 30 minutes on days -5 to -1 Patients planning to receive family member HLA-mismatched or unrelated bone marrow transplantation receive horse anti-thymocyte globulin IV once daily on days -5 and -4 Patients undergo allogeneic T-cell-depleted bone marrow transplantation on day 0 Patients receive filgrastim G-CSF IV every 12 hours beginning on day 7 and continuing until blood counts recover
Patients are followed every 2-4 weeks for the first 100 days post-transplantation every 6 weeks for 6 months every 3 months for 1 year and then every 3-6 months until 2 years post-transplantation
PROJECTED ACCRUAL A total of 50 patients 25 with HLA 66 antigen-matched related donors and 25 with HLA 56 antigen-matched related donors or HLA 56 or 66 antigen-matched unrelated donors will be accrued for this study within 3 years
Determine the efficacy of hyperfractionated total body irradiation thiotepa and cyclophosphamide followed by T-cell-depleted allogeneic bone marrow transplantation in children with acute myeloid leukemia acute lymphoblastic leukemia chronic myelogenous leukemia non-Hodgkins lymphoma or myelodysplastic syndromes
Correlate the progenitor cell dose and dose of clonable T cells with the incidence and quality of engraftment extent of chimerism incidence and severity of acute and chronic graft-versus-host disease characteristics of hematopoietic and immunologic reconstitution and overall and disease-free survival at 2 years in patients treated with this regimen
OUTLINE Patients undergo total body irradiation three times daily on days -9 to -7 and twice on day -6 Patients receive thiotepa IV over 4 hours on days -5 and -4 and cyclophosphamide IV over 30 minutes on days -3 and -2 Patients who cannot receive cyclophosphamide due to prior hemorrhagic cystitis or exposure to high-dose cyclophosphamide or ifosfamide receive fludarabine IV over 30 minutes on days -5 to -1 Patients planning to receive family member HLA-mismatched or unrelated bone marrow transplantation receive horse anti-thymocyte globulin IV once daily on days -5 and -4 Patients undergo allogeneic T-cell-depleted bone marrow transplantation on day 0 Patients receive filgrastim G-CSF IV every 12 hours beginning on day 7 and continuing until blood counts recover
Patients are followed every 2-4 weeks for the first 100 days post-transplantation every 6 weeks for 6 months every 3 months for 1 year and then every 3-6 months until 2 years post-transplantation
PROJECTED ACCRUAL A total of 50 patients 25 with HLA 66 antigen-matched related donors and 25 with HLA 56 antigen-matched related donors or HLA 56 or 66 antigen-matched unrelated donors will be accrued for this study within 3 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 |
|---|---|---|---|
| P30CA008748 | NIH | None | None |
| P01CA033049 | NIH | None | None |
| P01CA023766 | NIH | None | None |
| MSKCC-01105 | None | None | None |
| NCI-H01-0083 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA023766 |