Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies
N/A
35 Years
Both
Leukemia, Lymphocytic, Acute, AML, MDS
Trial Information
Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies
Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce
exposure to infectious agents.
Prior to transplantation, they will receive BUSULFAN via the central venous line, four times
a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days,
and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and
melphalan are given to destroy the subject's cancer. As well, these drugs will destroy
their immune system to help ensure the new stem cells take and grow after transplantation.
On the day of transplantation, umbilical cord blood from the donor will be transfused via
venous line. These new cells will replace the subject's bone marrow.
After transplantation, the subjects will receive Cyclosporin A and either MMF or MTX
Isolation will be continued until adequate numbers of cells are present in the blood to
fight infection. Subjects will be discharged from the hospital when medically ready. They
will be expected to return for follow-up to the blood and marrow transplant clinic at
specific dates as determined by physicians.
Inclusion Criteria:
- Patients must have a diagnosis of acute lymphocytic leukemia (ALL), acute myeloid
leukemia (AML) or myelodysplastic syndrome (MDS) and currently be in complete
remission.
- Patients must be either:
- - <18 years of age who are at least 6 months after initial hematopoietic cell
transplant (HCT),
- - 19-35 years of age and at least 18 months after initial HCT, or
- - <35 years of age and have received sufficient radiation treatment to be ineligible
for total body irradiation (TBI) containing preparative therapy
- Adequate major organ function including:
- - Cardiac: ejection fraction > or = 45%
- - Renal: creatinine clearance > or = 40 mL/min
- - Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
- - Karnofsky performance status > or = 70% or Lansky score > or = 50%
- Women of child bearing age must be using adequate birth control and have a negative
pregnancy test.
- Written informed consent.
Exclusion Criteria:
- Eligible for TBI containing preparative regimen.
- Active uncontrolled infection within one week of HCT.
- Pregnant or lactating females.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Probability of Long-term Disease-free Survival (DFS)
Outcome Description:
Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Margaret MacMillan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Institutional Review Board
Study ID:
2000LS040
NCT ID:
NCT00176839
Start Date:
June 2000
Completion Date:
October 2012
Related Keywords:
- Leukemia, Lymphocytic, Acute
- AML
- MDS
- Stem Cell transplant
- retransplant
- hematological malignancies
- Neoplasms
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Hematologic Neoplasms
Name | Location |
|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis, Minnesota 55455 |
