Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002718
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
1999-11-01
Brief Title:
T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia Lymphoblastic Lymphoma Myelodysplastic Syndrome or Aplastic Anemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of T-Cell Depleted Marrow Grafts Combined With Infusions of G-CSF Stimulated CD34 Ceprate Stem Cell Column Selected E-Rosette Depleted Peripheral Blood Progenitor Cells Derived From HLA Haplotype Matched Related Donors for Patients With Leukemia Lacking an HLA-Matched Related or Unrelated Donor
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 Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells
PURPOSE Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF stimulated peripheral stem cell transplantation in treating patients with leukemia lymphoblastic lymphoma myelodysplastic syndrome or aplastic anemia
PURPOSE Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF stimulated peripheral stem cell transplantation in treating patients with leukemia lymphoblastic lymphoma myelodysplastic syndrome or aplastic anemia
Detailed Description:
OBJECTIVES
Determine the potential of T-cell-depleted bone marrow and peripheral blood stem cells PBSC from HLA-haplotype partially matched related donors to induce extended disease-free survival in patients with leukemia lymphoblastic lymphoma myelodysplastic syndrome or severe aplastic anemia who would otherwise be ineligible for transplantation because of the lack of an HLA-identical related or unrelated donor
Determine the impact of filgrastim G-CSF-stimulated CD34 E-rosette and T-cell-depleted PBSC derived from an HLA-haplotype partially matched donor on the incidence and quality of engraftment kinetics and quality of hematopoietic and immunologic reconstitution and incidence and severity of graft-versus-host disease GVHD in these patients
Correlate the doses of PBSC and clonable T-cells with the incidence of engraftment extent of chimerism incidence and severity of acute and chronic GVHD characteristics of hematopoietic and immunologic reconstitution and overall and disease-free survival rates at 2-4 years after transplantation in these patients
OUTLINE Patients are stratified by number of HLA-incompatible alleles 1 vs 2 or 3
Harvest Beginning 6-10 days before transplantation allogeneic bone marrow is harvested and treated in vitro Beginning 5-6 days before transplantation filgrastim G-CSF-stimulated allogeneic peripheral blood stem cells PBSC are harvested selected for CD34 cells and treated in vitro If feasible autologous bone marrow is harvested in the event of allogeneic graft failure
Myeloablation Patients undergo total body irradiation 3 times a day on days -9 to -6 thiotepa IV over 4 hours on days -5 and -4 and cyclophosphamide IV on days -3 and -2
Transplantation CD34 E-rosette and T-cell-depleted PBSC are infused over 15 minutes and then T-cell-depleted bone marrow is infused over 1-5 minutes on day 0 Patients receive G-CSF IV over 30 minutes beginning on day 1 and continuing until blood counts recover and then tapering Patients receive anti-thymocyte globulin IV over 4-6 hours on days 8 10 12 and 14 and oral methylprednisolone on days 8-14 followed by tapered doses on days 15-17
CNS prophylaxis Beginning at least 2 months after transplantation patients with acute lymphocytic leukemia ALL and no history of CNS leukemia receive cytarabine intrathecally IT monthly for 6 months and patients with ALL and a history of CNS leukemia receive cytarabine IT monthly for 12 months
Patients with graft failure are offered autologous bone marrow transplantation BMT or second allogeneic BMT
Patients are followed at 1 3 6 and 12 months and then annually for 3 years
Determine the potential of T-cell-depleted bone marrow and peripheral blood stem cells PBSC from HLA-haplotype partially matched related donors to induce extended disease-free survival in patients with leukemia lymphoblastic lymphoma myelodysplastic syndrome or severe aplastic anemia who would otherwise be ineligible for transplantation because of the lack of an HLA-identical related or unrelated donor
Determine the impact of filgrastim G-CSF-stimulated CD34 E-rosette and T-cell-depleted PBSC derived from an HLA-haplotype partially matched donor on the incidence and quality of engraftment kinetics and quality of hematopoietic and immunologic reconstitution and incidence and severity of graft-versus-host disease GVHD in these patients
Correlate the doses of PBSC and clonable T-cells with the incidence of engraftment extent of chimerism incidence and severity of acute and chronic GVHD characteristics of hematopoietic and immunologic reconstitution and overall and disease-free survival rates at 2-4 years after transplantation in these patients
OUTLINE Patients are stratified by number of HLA-incompatible alleles 1 vs 2 or 3
Harvest Beginning 6-10 days before transplantation allogeneic bone marrow is harvested and treated in vitro Beginning 5-6 days before transplantation filgrastim G-CSF-stimulated allogeneic peripheral blood stem cells PBSC are harvested selected for CD34 cells and treated in vitro If feasible autologous bone marrow is harvested in the event of allogeneic graft failure
Myeloablation Patients undergo total body irradiation 3 times a day on days -9 to -6 thiotepa IV over 4 hours on days -5 and -4 and cyclophosphamide IV on days -3 and -2
Transplantation CD34 E-rosette and T-cell-depleted PBSC are infused over 15 minutes and then T-cell-depleted bone marrow is infused over 1-5 minutes on day 0 Patients receive G-CSF IV over 30 minutes beginning on day 1 and continuing until blood counts recover and then tapering Patients receive anti-thymocyte globulin IV over 4-6 hours on days 8 10 12 and 14 and oral methylprednisolone on days 8-14 followed by tapered doses on days 15-17
CNS prophylaxis Beginning at least 2 months after transplantation patients with acute lymphocytic leukemia ALL and no history of CNS leukemia receive cytarabine intrathecally IT monthly for 6 months and patients with ALL and a history of CNS leukemia receive cytarabine IT monthly for 12 months
Patients with graft failure are offered autologous bone marrow transplantation BMT or second allogeneic BMT
Patients are followed at 1 3 6 and 12 months and then annually for 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 |
|---|---|---|---|
| NCI-V96-0809 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-95084 | None | None | None |