Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002502
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Leukemia or Myelodysplastic Syndrome
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
BUSULFAN AND CYCLOPHOSPHAMIDE FOR CYTOREDUCTION OF PATIENTS WITH ACUTE AND CHRONIC LEUKEMIAS AND MYELODYSPLASTIC SYNDROMES UNDERGOING ALLOGENEIC BONE MARROW TRANSPLANTATION WHO CANNOT BE TREATED WITH TOTAL BODY IRRADIATION
Status:
COMPLETED
Status Verified Date:
2013-06
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients who have acute or chronic leukemia or myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients who have acute or chronic leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the effect of marrow ablation with high dose busulfancyclophosphamide on engraftment incidence of posttransplant relapse incidence and severity of graft versus host disease GVHD and incidence and severity of nonGVHD posttransplant complications in patients with acute or chronic leukemia or myelodysplastic syndrome who are eligible for allogeneic bone marrow transplants from HLA identicalcompatible donors but who cannot or should not receive total body irradiation as part of their cytoreductive regimen
OUTLINE 2-Drug Combination Cytoreductive Chemotherapy followed by Bone Marrow Transplant with as indicated CNS Prophylaxis Busulfan BU NSC-750 Cyclophosphamide CTX NSC-26271 followed by Allogeneic Bone Marrow AlBM with as indicated Intrathecal Cytarabine IT ARA-C NSC-63878
PROJECTED ACCRUAL At least 15 patients will be accrued for this study
OUTLINE 2-Drug Combination Cytoreductive Chemotherapy followed by Bone Marrow Transplant with as indicated CNS Prophylaxis Busulfan BU NSC-750 Cyclophosphamide CTX NSC-26271 followed by Allogeneic Bone Marrow AlBM with as indicated Intrathecal Cytarabine IT ARA-C NSC-63878
PROJECTED ACCRUAL At least 15 patients will be accrued for this study
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-H92-0143 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000077927 | REGISTRY | None | None |