Clinical trial NCT01685411: Busulfan and Cyclophosphamide Followed By ALLO BMT
Official title: Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 5
Sex: ALL
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a treatment guideline to allow routine clinical data to be collected and maintained in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as part of the historical database maintained by the department.

Detailed description: 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.

Eligibility criteria: 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 following:

  * \<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

Primary outcomes:
measure: Counts of Participants With Disease Free Survival
timeFrame: 2 Years
measure: Count of Participants With Disease Free Survival
timeFrame: 5 Years
measure: Count of Participants With Disease Free Survival
timeFrame: 7 Years
Secondary outcomes:
measure: Count of Participants Who Achieved Neutrophil Engraftment
timeFrame: By Day 42
measure: Percentage of Participants With Acute Graft-Versus-Host Disease by Grade
timeFrame: Day 100
measure: Percentage of Participants With Chronic Graft-Versus-Host Disease
timeFrame: 6 Months
measure: Percentage of Participants With Chronic Graft-Versus-Host Disease
timeFrame: 1 Year
measure: Percentage of Participants With Treatment-Related Toxicity
timeFrame: 6 Months
measure: Percentage of Participants With Treatment-Related Toxicity
timeFrame: 1 year
measure: Percentage of Participants With Relapse
timeFrame: 1 Year
measure: Percentage of Participants With Relapse
timeFrame: 2 Years
measure: Percentage of Participants With Engraftment Failure
timeFrame: Day 42
measure: Number of Participant Who Were Alive at 2 Years Post Transplant
timeFrame: 2 Years
measure: Number of Participant Who Were Alive at 5 Years Post Transplant
timeFrame: 5 Years
measure: Number of Participant Who Were Alive at 7 Years Post Transplant
timeFrame: 7 Years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Margaret L. MacMillan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: