Busulfan and Cyclophosphamide Followed By ALLO BMT

University of Minnesota (UMN)

Status

Terminated

Conditions

Acute Lymphoblastic Leukemia

Myelodysplastic Syndrome

Acute Myeloid Leukemia

Treatments

Drug: Tacrolimus

Biological: antithymocyte globulin

Biological: Filgrastim

Drug: Busulfan

Drug: Mycophenolate mofetil

Drug: Allopurinol

Biological: Allogeneic hematopoietic stem cell transplant

Drug: Keppra

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT01685411

2011OC139

MT2011-20C (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

Under 44 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Allogeneic Hematopoietic Stem Cell Transplant

Experimental group

Description:

Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.

Treatment: