Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258427
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2005-11-22
Brief Title:
Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia MT2002-02
Status:
COMPLETED
Status Verified Date:
2021-11
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 A bone marrow or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy Giving combination chemotherapy before a donor stem cell transplant may make the transplant more likely to work This may be an effective treatment for patients with high risk Fanconis anemia
PURPOSE This clinical trial is studying how well combination chemotherapy works in treating high risk patients who are undergoing a donor stem cell transplant for Fanconis anemia
PURPOSE This clinical trial is studying how well combination chemotherapy works in treating high risk patients who are undergoing a donor stem cell transplant for Fanconis anemia
Detailed Description:
OBJECTIVES
Primary
Determine whether the incidence of neutrophil engraftment is acceptable in high-risk patients with Fanconis anemia treated with busulfan cyclophosphamide fludarabine and antithymocyte globulin followed by allogeneic hematopoietic stem cell transplantation
Secondary
Determine the tolerability of mycophenolate mofetil in these patients
Determine the incidence of acute and chronic graft-vs-host disease in patients treated with this regimen
Determine the incidence of major infections in patients with a history of major infections treated with this regimen
Determine the incidence of relapse in patients with refractory anemia with excess blasts refractory anemia with excess blasts in transformation or acute myeloid leukemia treated with this regimen
Determine the probability of 1-year survival of patients treated with this regimen
OUTLINE Patients are stratified according to donorrecipient HLA type identical vs other
Cytoreductive combination chemotherapy Patients receive busulfan intravenously IV over 2 hours twice daily on days -7 and -6 and cyclophosphamide IV over 2 hours and fludarabine IV over 30 minutes once daily on days -5 to -2
Graft failure prophylaxis Patients receive methylprednisolone IV twice daily on days -5 to 30 and anti-thymocyte globulin IV over 4-6 hours twice daily on days -5 to -1
Graft-vs-host disease prophylaxis Patients receive cyclosporine IV over 2 hours twice daily on days -3 to 100 if patient has a matched sibling donor or days -3 to 180 if patient has another donor type Patients also receive mycophenolate mofetil orally or IV twice daily on days -3 to 45
Allogeneic hematopoietic stem cell transplantation HSCT Patients undergo allogeneic HSCT using bone marrow or umbilical cord blood on day 0 Patients receive filgrastim G-CSF subcutaneously beginning on day 1 and continuing until blood counts recover
After completion of study treatment patients are followed periodically for 3 years
Primary
Determine whether the incidence of neutrophil engraftment is acceptable in high-risk patients with Fanconis anemia treated with busulfan cyclophosphamide fludarabine and antithymocyte globulin followed by allogeneic hematopoietic stem cell transplantation
Secondary
Determine the tolerability of mycophenolate mofetil in these patients
Determine the incidence of acute and chronic graft-vs-host disease in patients treated with this regimen
Determine the incidence of major infections in patients with a history of major infections treated with this regimen
Determine the incidence of relapse in patients with refractory anemia with excess blasts refractory anemia with excess blasts in transformation or acute myeloid leukemia treated with this regimen
Determine the probability of 1-year survival of patients treated with this regimen
OUTLINE Patients are stratified according to donorrecipient HLA type identical vs other
Cytoreductive combination chemotherapy Patients receive busulfan intravenously IV over 2 hours twice daily on days -7 and -6 and cyclophosphamide IV over 2 hours and fludarabine IV over 30 minutes once daily on days -5 to -2
Graft failure prophylaxis Patients receive methylprednisolone IV twice daily on days -5 to 30 and anti-thymocyte globulin IV over 4-6 hours twice daily on days -5 to -1
Graft-vs-host disease prophylaxis Patients receive cyclosporine IV over 2 hours twice daily on days -3 to 100 if patient has a matched sibling donor or days -3 to 180 if patient has another donor type Patients also receive mycophenolate mofetil orally or IV twice daily on days -3 to 45
Allogeneic hematopoietic stem cell transplantation HSCT Patients undergo allogeneic HSCT using bone marrow or umbilical cord blood on day 0 Patients receive filgrastim G-CSF subcutaneously beginning on day 1 and continuing until blood counts recover
After completion of study treatment patients are followed periodically 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 |
|---|---|---|---|
| 0202M18741 | OTHER | IRB University of Minnesota | None |
| MT2002-02 | OTHER | None | None |