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A Non-Myeloablative Conditioning Regimen for Allogeneic Transplantation With Clofarabine, Cytarabine, and Thymoglobulin for Myelodysplastic Syndrome and Acute Myeloid Leukemia

Phase 2
18 Years
Not Enrolling
Myelodysplastic Syndromes, Acute Myeloid Leukemia

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Trial Information

A Non-Myeloablative Conditioning Regimen for Allogeneic Transplantation With Clofarabine, Cytarabine, and Thymoglobulin for Myelodysplastic Syndrome and Acute Myeloid Leukemia

Current reduced intensity conditioning regimens have been able to decrease TRM (treatment
related mortality) but suffer from increased rates of disease relapse. Disease burden at
transplantation, as measured by percent myeloblasts, predicts relapse. Current regimens
employ fludarabine and busulfan with various adjutants, but these agents are not part of the
usual armamentarium used versus leukemia and have questionable anti-leukemic activity. By
substituting clofarabine and cytarabine, a combination with proven anti-leukemic activity in
the relapsed and refractory setting as well as activity versus MDS, as the back bone of the
regimen we hope overcome residual disease and improve post-transplant relapse rates.
Furthermore the principal toxicity of this regimen is myelosuppression, which should be
abrogated by the infusion of stem cells. Thymoglobulin is included due to its minimal
contribution to toxicity but significant benefits in engraftment, and controlling acute and
chronic GVHD, which are major contributors to TRM and disease specific activity in MDS.

Inclusion Criteria

Inclusion Criteria (Patient):

1. Myelodysplastic Syndrome (MDS), as defined by the World Health Organization criteria,
OR Chronic Myelomonocytic Leukemia (CMML) as defined by the French American British
classification OR Acute Myeloid Leukemia (AML) in complete remission [excluding
FAB-M3] diagnosed by standard criteria and meet the criteria below:

1. Patients may be in any CR

2. No more than 2 cycles of consolidation. Any consolidation regimen may be used.

3. No more than 6 months from documented CR to transplant.

2. Age 18 years or older.

3. ECOG performance status <=2

4. Identification of suitable donor

5. DLCO >=40% with no symptomatic pulmonary disease

6. LVEF by MUGA >= 30%

7. Serum creatinine <=1.0 mg/dL; if serum creatinine >1.0 mg/dL, then the estimated
glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the
Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2)
= 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is
female) x (1.212 if patient is black).

8. Bilirubin <=2 times the upper limit of normal

9. AST <=3 times the upper limit of normal

Donor criteria:

1. HLA-Matched Sibling: The donor must be an adequate HLA match as determined by
serologic typing for class (A, B) and low resolution molecular typing for class II
(DRB1) as defined by institutional standards.

2. Matched Unrelated Donor: An acceptable match per NMDP standards based on high
resolution molecular typing.

3. The donor must be healthy and must be an acceptable donor as per institutional
standards for stem cell collection.

4. The donor must have no significant cardiopulmonary, renal, endocrine, or hepatic

5. There is no upper age restriction for donors, but they must be at least 18 years of

6. Syngeneic donors are not eligible.

7. No known HIV.

Exclusion Criteria:

1. Pregnant or nursing.

2. Active systemic infection considered opportunistic, life threatening or clinically
significant at the time of treatment.

3. Severe concurrent disease, including severe insulin-dependent diabetes, uncontrolled
hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery
disease, or symptomatic CNS involvement or psychiatric illness/social situations that
would limit compliance with study requirements.

4. Known HIV disease.

5. History of other malignancy except for basal cell or squamous cell carcinoma of the
skin or carcinoma in situ of the cervix or breast unless the subject has been off
treatment and free from disease for > 3 years.

6. Active disease at the time of transplant.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the six-month treatment related mortality for a conditioning regimen composed of clofarabine, cytarabine, and thymoglobulin for allogeneic transplantation of myelodysplastic syndromes and acute myeloid leukemia.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Ravi Vij, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington Universtiy of St. Louis


United States: Institutional Review Board

Study ID:




Start Date:

November 2007

Completion Date:

July 2009

Related Keywords:

  • Myelodysplastic Syndromes
  • Acute Myeloid Leukemia
  • Conditioning regimens
  • Stem Cell Transplantation
  • Hematopoietic Stem Cell Transplantation
  • Allogeneic Stem Cell Transplantation
  • Nonmyeloablative conditioning
  • Clofarabine
  • Cytarabine
  • Anti-thymocyte globulin
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



Ravi Vij, M.D. St. Louis, Missouri  63110