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Phase II Study of Reduced Intensity Conditioning With Busulfan/Clofarabine Followed by Allogeneic Stem Cell Transplantation

Phase 2
18 Years
Open (Enrolling)
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome

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Trial Information

Phase II Study of Reduced Intensity Conditioning With Busulfan/Clofarabine Followed by Allogeneic Stem Cell Transplantation

You will start the conditioning regimen, which is also called the preparative regimen.
Conditioning is done to kill more cancer cells which may remain as well as prepare your body
for transplant. You will receive the conditioning drugs into a vein. The conditioning
regimen consists of the following drugs: Busulfan and Clofarabine.

While you are in the hospital you will have regular physical exams and you will be asked
specific questions about any problems that you might be having. You will also have blood
tests every day to look at how your bone marrow is recovering, to give possible
transfusional support, and how to see how your liver and kidneys are functioning.

You will receive the following drugs before and after the allogeneic stem cell transplant:
Neupogen (G-CSF) injections, drugs to prevent infections, Tacrolimus to prevent GVHD and

You will have routine and regular follow-up in the transplant clinic after discharge from
the hospital. The following will be performed at each visit:

Physical exam to monitor your health and check for signs of GVHD, infections and any side
effects you may be having; Blood draw for routine blood tests to measure your blood cell
count and chemistry; Blood tests to see if the transplanted stem cells are being accepted
and are growing in the body (engraftment); Bone marrow biopsy to see the status of the
underlying disease (to be done around 100 days after the stem cell transplant).

You will be asked to return to the clinic, at a minimum, for follow-up visits at 6 months, 9
months, 12 months, 18 months and 24 months after your stem cell transplant.

Inclusion Criteria:

- Must have well-matched adult donor willing to donate peripheral blood stem cells with
well-matched defined as 8/8 matched related or unrelated donor

- Adequate organ functioning

Exclusion Criteria:

- Pregnant or breastfeeding

- Psychiatric disease severely impairing the compliance of the patient to participate
in the study and/or give informed consent

- Evidence of prior exposure to HIV or HCV

Type of Study:


Study Design:

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

Outcome Measure:

Assessment of donor stem cell engraftment: ANC count

Outcome Description:

ANC at least 500/uL and at least 75% of hematopoietic elements are donor-derived as determined by chimerism assays from peripheral blood prior to day +40 after Busulfan/Clofarabine (BuClo) reduced intensity allogeneic stem cell transplantation

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Yi-Bin Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

July 2015

Related Keywords:

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



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617