Ignite Creation Date:
2024-05-05 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00553202
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2007-11-02
Brief Title:
Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7 -55q- High FLT3-ITD AR or Refractory or Relapsed Acute Myelogenous Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Killer Immunoglobulin-like Receptor KIR Incompatible Unrelated Donor Hematopoietic Cell Transplantation SCT for AML With Monosomy 7 -55q- High FLT3-ITD AR or Refractory and Relapsed Acute Myelogenous Leukemia AML in Children A Childrens Oncology Group COG Study
Status:
COMPLETED
Status Verified Date:
2016-07
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 before a donor stem cell transplant using stem cells that closely match the patients stem cells helps stop the growth of cancer cells It also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving antithymocyte globulin before transplant and cyclosporine tacrolimus and methotrexate before and after transplant may stop this from happening
PURPOSE Natural Killer NK cells from the donors bone marrow may be important in fighting leukemia Bone marrow donors can be selected based on the type of NK cells they have specifically the killer immunoglobulin receptor KIR type This study provides information on KIR type from potential donors which can be used in selecting the bone marrow donor This phase II trial of unrelated donor stem cell transplant in patients with high risk AML monosomy 7 -55q- high FLT3-ITD AR or refractory or relapsed AML in which KIR typing of the patients and potential donors will be available to the treating transplant physician at the time of donor selection
PURPOSE Natural Killer NK cells from the donors bone marrow may be important in fighting leukemia Bone marrow donors can be selected based on the type of NK cells they have specifically the killer immunoglobulin receptor KIR type This study provides information on KIR type from potential donors which can be used in selecting the bone marrow donor This phase II trial of unrelated donor stem cell transplant in patients with high risk AML monosomy 7 -55q- high FLT3-ITD AR or refractory or relapsed AML in which KIR typing of the patients and potential donors will be available to the treating transplant physician at the time of donor selection
Detailed Description:
OBJECTIVES
To define the relationship between the status of donor NK-cell receptor and patient outcomes after killer immunoglobulin-like receptor-incompatible unrelated donor URD and umbilical cord blood UCB hematopoietic cell transplantation HCT in young patients with acute myeloid leukemia with monosomy 7 -55q- high FLT3 internal tandem duplication allelic ratio High-FLT3-ITD AR or refractory or relapsed acute myelogenous leukemia
To correlate the relationships between factors affecting NK receptor status and clinical events
To assess NK-cell development after URD and UCB HCT in patients with poor prognosis AML
To evaluate NK-cell reconstitution and receptor-acquisition pattern in these patients
OUTLINE This is a multicenter study
Preparative regimen Patients receive 1 of the following regimens
Hematopoietic stem cell transplantation SCT Patients receive busulfan IV every 6 hours on days -9 to -6 high-dose cyclophosphamide IV over 1 hour on days -5 to -2 anti-thymocyte globulin IV once or twice daily over 4 hours on days -3 to -1 and methylprednisolone IV on days -3 to -1
Umbilical cord blood UCB transplantation Conditioning regimen infusion procedures and post-transplant immunoprophylaxis for patients with an UCB donor are according to institutional guidelines and standards
Allogeneic hematopoietic stem cell transplantation SCT or umbilical cord blood UCB transplant Patients undergo allogeneic SCT or UCB transplant on day 0
Graft-vs-host disease GVHD prophylaxis Patients receive cyclosporine or tacrolimus IV or orally beginning on day -2 and continuing until day 50 followed by a taper until week 24 Patients also receive methotrexate IV on days 1 3 6 and 11
Blood samples will be collected periodically from both patients and donors for studies of natural killer cells in support of the study objectives
After completion of study treatment patients are followed every 6 months for 2 years and then annually for 3 years
To define the relationship between the status of donor NK-cell receptor and patient outcomes after killer immunoglobulin-like receptor-incompatible unrelated donor URD and umbilical cord blood UCB hematopoietic cell transplantation HCT in young patients with acute myeloid leukemia with monosomy 7 -55q- high FLT3 internal tandem duplication allelic ratio High-FLT3-ITD AR or refractory or relapsed acute myelogenous leukemia
To correlate the relationships between factors affecting NK receptor status and clinical events
To assess NK-cell development after URD and UCB HCT in patients with poor prognosis AML
To evaluate NK-cell reconstitution and receptor-acquisition pattern in these patients
OUTLINE This is a multicenter study
Preparative regimen Patients receive 1 of the following regimens
Hematopoietic stem cell transplantation SCT Patients receive busulfan IV every 6 hours on days -9 to -6 high-dose cyclophosphamide IV over 1 hour on days -5 to -2 anti-thymocyte globulin IV once or twice daily over 4 hours on days -3 to -1 and methylprednisolone IV on days -3 to -1
Umbilical cord blood UCB transplantation Conditioning regimen infusion procedures and post-transplant immunoprophylaxis for patients with an UCB donor are according to institutional guidelines and standards
Allogeneic hematopoietic stem cell transplantation SCT or umbilical cord blood UCB transplant Patients undergo allogeneic SCT or UCB transplant on day 0
Graft-vs-host disease GVHD prophylaxis Patients receive cyclosporine or tacrolimus IV or orally beginning on day -2 and continuing until day 50 followed by a taper until week 24 Patients also receive methotrexate IV on days 1 3 6 and 11
Blood samples will be collected periodically from both patients and donors for studies of natural killer cells in support of the study objectives
After completion of study treatment patients are followed every 6 months for 2 years 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-2009-00321 | REGISTRY | NCI Trial Identifier | None |
| COG-AAML05P1 | OTHER | None | None |