Clofarabine, Cytarabine, and Thymoglobulin for Allogeneic Transplantation
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ClinicalTrials.gov Identifier: NCT00593645 |
Recruitment Status :
Terminated
(toxicities were worse than expected)
First Posted : January 15, 2008
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
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Condition or disease | Intervention/treatment | Phase |
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Myelodysplastic Syndromes Acute Myeloid Leukemia | Drug: Clofarabine Drug: Cytarabine Drug: Thymoglobulin Procedure: Stem cell infusion | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Non-Myeloablative Conditioning Regimen for Allogeneic Transplantation With Clofarabine, Cytarabine, and Thymoglobulin for Myelodysplastic Syndrome and Acute Myeloid Leukemia |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
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Experimental: Arm 1: Non-myeloablative conditioning regimen
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Drug: Clofarabine
Other Name: Clolar Drug: Cytarabine Other Names:
Drug: Thymoglobulin Other Name: Anti-thymocyte globulin Procedure: Stem cell infusion Other Names:
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- Six-month Treatment Related Mortality [ Time Frame: 6 months ]
- Disease Specific Response Rates [ Time Frame: One, three, six and twelve months. ]Disease-specific partial response and complete response.
- Engraftment as Measured by Percent Donor Chimerism [ Time Frame: Day +30 ]
- Engraftment as Measured by Percent Donor Chimerism [ Time Frame: Day +40-+60 ]
- Engraftment as Measured by Percent Donor Chimerism [ Time Frame: Day +80-+90 ]
- Overall Survival [ Time Frame: 5 years from time of restaging ]
- Disease-free Survival [ Time Frame: 5 years from time of restaging ]Disease-free survival is defined as the length of time after treatment ends that the participant survives without any signs or symptoms of that cancer.
- Rate of Acute Graft-versus-host Disease (GVHD) [ Time Frame: Up to 100 days after transplant ]Acute GVHD occurs within 100 days of transplant.
- Rate of Chronic Graft-versus-host Disease (GVHD) [ Time Frame: 100 days-1 year after transplant ]
- Use Conventional STR-PCR Method for Monitoring Engraftment [ Time Frame: Up to 1 year after transplant ]Includes assessment of mixed chimerism in the whole blood, myeloid cells, T cells, and B cells.
- Median Time to Progression [ Time Frame: 5 years from time of restaging ]Time to progression is defined as the length of time from the start of treatment until the disease starts to get worse or spread to other parts of the body.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Patient):
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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:
- Patients may be in any CR
- No more than 2 cycles of consolidation. Any consolidation regimen may be used.
- No more than 6 months from documented CR to transplant.
- Age 18 years or older.
- ECOG performance status <=2
- Identification of suitable donor
- DLCO >=40% with no symptomatic pulmonary disease
- LVEF by MUGA >= 30%
- 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).
- Bilirubin <=2 times the upper limit of normal
- AST <=3 times the upper limit of normal
Donor criteria:
- 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.
- Matched Unrelated Donor: An acceptable match per NMDP standards based on high resolution molecular typing.
- The donor must be healthy and must be an acceptable donor as per institutional standards for stem cell collection.
- The donor must have no significant cardiopulmonary, renal, endocrine, or hepatic disease.
- There is no upper age restriction for donors, but they must be at least 18 years of age.
- Syngeneic donors are not eligible.
- No known HIV.
Exclusion Criteria:
- Pregnant or nursing.
- Active systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- 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.
- Known HIV disease.
- 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.
- Active disease at the time of transplant.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593645
United States, Missouri | |
Ravi Vij, M.D. | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Ravi Vij, M.D. | Washington Universtiy of St. Louis |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00593645 |
Other Study ID Numbers: |
07-0702 No grant number |
First Posted: | January 15, 2008 Key Record Dates |
Results First Posted: | September 12, 2014 |
Last Update Posted: | September 12, 2014 |
Last Verified: | September 2014 |
Conditioning regimens Stem Cell Transplantation Hematopoietic Stem Cell Transplantation Allogeneic Stem Cell Transplantation |
Nonmyeloablative conditioning Clofarabine Cytarabine Anti-thymocyte globulin |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Cytarabine Clofarabine |
Thymoglobulin Antilymphocyte Serum Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |