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Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies

44 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information

Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies

This is a single arm trial to evaluate the efficacy of busulfan and cyclophosphamide
followed by an allogeneic hematopoietic stem cell transplant (HSCT) in the treatment of
hematological malignancies. The intent of this study is to provide a protocol that will use
unmanipulated allogeneic hematopoietic stem cells from related and unrelated donors after a
common preparative regimen. Results will be compared to historical controls.

Inclusion Criteria:

- Diagnosis of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) or
myelodysplastic syndrome (MDS) and current in complete remission meeting one of the

- <45 years of age who are at least 6 months after initial hematopoietic stem cell
transplant (HSCT)

- <45 years of age and have received sufficient radiation treatment to be
ineligible for total body irradiation (TBI) containing preparative therapy

- Karnofsky performance status >70% or if <16 years of age, a Lansky play score >50

- Adequate major organ function including:

- cardiac: left ventricular ejection fraction >45% by echocardiogram (ECHO/MUGA)

- renal: creatinine clearance >40 mL/min/1.73m^2

- hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites)

- An acceptable source of stem cells according to current University of Minnesota Bone
Marrow Transplant program guidelines. Acceptable stem cell sources include:

- HLA-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match)

- HLA-matched related or unrelated donor peripheral blood stem cells

- related or single or double unrelated donor umbilical cord blood (6/6, 5/6 or
4/6 match)

- Women of childbearing age must have a negative pregnancy test and all sexually active
participants must agree to use effective contraception during study treatment

- Written consent (adult or parent/guardian)

Exclusion Criteria:

- eligible for TBI containing preparative regimen

- active uncontrolled infection within one week of study enrollment

- pregnant or lactating female

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Free Survival

Outcome Description:

The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.

Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

Margaret L. MacMillan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Institutional Review Board

Study ID:




Start Date:

January 2013

Completion Date:

September 2022

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms



Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455