Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003816
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia
Status:
COMPLETED
Status Verified Date:
2021-07
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 drugs and total-body irradiation before a donor stem cell helps stop the growth of cancer or abnormal cells It may also 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 It is not yet known which combination chemotherapy regimen is most effective when given before a donor stem cell transplant in treating aplastic anemia or hematologic cancer
PURPOSE This phase IIIII trial is studying different combination chemotherapy regimens to compare how well they work when given before donor stem cell transplant in treating patients with aplastic anemia or hematologic cancer
PURPOSE This phase IIIII trial is studying different combination chemotherapy regimens to compare how well they work when given before donor stem cell transplant in treating patients with aplastic anemia or hematologic cancer
Detailed Description:
OBJECTIVES
Compare the morbidity mortality and overall outcome of patients with severe aplastic anemia or hematologic malignancy treated with standard vs novel conditioning regimens followed by allogeneic stem cell transplantation
Examine the influence of donor histocompatibility on outcome by comparing matchedrelated mismatchedrelated with or without T-cell depletion and matchedunrelated transplants with stratification for type of preparative regimen
Ensure that patients with uncommon diagnoses will be treated in a uniform fashion with the best therapy available
OUTLINE Patients are stratified according to risk of relapse standard-risk acute leukemia in first complete remission chronic myelogenous leukemia in first chronic phase lymphoma in sensitive first relapse or second remission primary or untreated myelodysplastic syndromes or untreated severe aplastic anemia vs high-risk all others
Patients are assigned to one of the following conditioning regimens based on diagnosis risk of relapse and donor relatedness
Regimen 1 Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2
Regimen 2 Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3
Regimen 3 Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation TBI twice daily on days -3 to -1
Regimen 4 Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2
Regimen 5 Patients receive etoposide IV over 26 hours beginning on day -5 cyclophosphamide IV over 2 hours on day -4 and TBI twice daily on days -3 to -1
Regimen 6 Patients receive cyclophosphamide IV over 24 hours carboplatin IV over 24 hours and thiotepa IV over 24 hours on days -7 to -4
Regimen 7 Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2
Regimen 8 Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 TBI twice daily on days -3 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1
Regimen 9 Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2
All patients then receive donor stem cell infusions on day 0 Some patients may undergo involved-field radiotherapy 4-8 weeks after transplant
Patients will be taken off study after a minimum of 4 years of follow up
PROJECTED ACCRUAL At least 405 patients will be accrued for this study within 5 years
Compare the morbidity mortality and overall outcome of patients with severe aplastic anemia or hematologic malignancy treated with standard vs novel conditioning regimens followed by allogeneic stem cell transplantation
Examine the influence of donor histocompatibility on outcome by comparing matchedrelated mismatchedrelated with or without T-cell depletion and matchedunrelated transplants with stratification for type of preparative regimen
Ensure that patients with uncommon diagnoses will be treated in a uniform fashion with the best therapy available
OUTLINE Patients are stratified according to risk of relapse standard-risk acute leukemia in first complete remission chronic myelogenous leukemia in first chronic phase lymphoma in sensitive first relapse or second remission primary or untreated myelodysplastic syndromes or untreated severe aplastic anemia vs high-risk all others
Patients are assigned to one of the following conditioning regimens based on diagnosis risk of relapse and donor relatedness
Regimen 1 Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2
Regimen 2 Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3
Regimen 3 Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation TBI twice daily on days -3 to -1
Regimen 4 Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2
Regimen 5 Patients receive etoposide IV over 26 hours beginning on day -5 cyclophosphamide IV over 2 hours on day -4 and TBI twice daily on days -3 to -1
Regimen 6 Patients receive cyclophosphamide IV over 24 hours carboplatin IV over 24 hours and thiotepa IV over 24 hours on days -7 to -4
Regimen 7 Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2
Regimen 8 Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 TBI twice daily on days -3 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1
Regimen 9 Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2
All patients then receive donor stem cell infusions on day 0 Some patients may undergo involved-field radiotherapy 4-8 weeks after transplant
Patients will be taken off study after a minimum of 4 years of follow up
PROJECTED ACCRUAL At least 405 patients will be accrued for this study within 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 |
|---|---|---|---|
| RP 98-15 | OTHER | Roswell Park Cancer Institute | None |