Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT02750254|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2016
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphocytic Leukemia||Drug: Fludarabine Radiation: Fractionated total body irradiation Drug: Busulfan Drug: Cyclophosphamide Radiation: Single dose total body irradiation Drug: Melphalan Drug: Granulocyte-colony stimulating factor Procedure: Stem cell transplant Drug: Azacitidine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation|
|Actual Study Start Date :||June 27, 2016|
|Actual Primary Completion Date :||May 24, 2017|
|Estimated Study Completion Date :||October 14, 2020|
Experimental: Arm 1: Azacitidine
Radiation: Fractionated total body irradiation
Radiation: Single dose total body irradiation
Drug: Granulocyte-colony stimulating factor
Procedure: Stem cell transplant
- Safety of azacitidine (Phase I only) as measured by frequency and grade of adverse events [ Time Frame: Up to Day 35 ]The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
- Maximum tolerated dose of azacitidine (Phase I only) [ Time Frame: Estimated to be 3-4 months (completion of all Phase I patients through Day 35) ]
- Grade II-IV acute GvHD rate of azacitidine (Phase II only) [ Time Frame: Up to Day 100 ]
- Event-free survival (EFS) [ Time Frame: Up to 48 months ]EFS is defined as the time from date of first dose of the preparative regimen until failure to engraft, treatment failure, disease progression/relapse, or death from any cause (whichever occurs first).
- Overall survival (OS) [ Time Frame: Up to 48 months ]OS is defined as the time from the date of Day 0 until death from any cause.
- Disease-free survival (DFS) [ Time Frame: Up to 48 months ]
- Non-relapse mortality (NRM) [ Time Frame: Up to Day 100 ]NRM is defined as death that results from a transplant procedure-related complication (e.g. infection, organ failure, hemorrhage, GvHD) rather than from relapse of the underlying disease prior to Day +100 visit.
- Time to neutrophil engraftment [ Time Frame: Up to 12 months ]Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen-induced nadir.
- Time to platelet engraftment [ Time Frame: Up to 12 months ]Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 20,000/ul without platelet transfusion support for 7 days.
- Rate of acute GvHD [ Time Frame: Up to Day 100 ]Incidence and severity of acute GvHD will be assessed based on the modified Glucksberg criteria and Seattle criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
- Rate of chronic GvHD [ Time Frame: Day 100 through Day 365 ]Incidence and severity of chronic GvHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
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): NCT02750254
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Mark Schroeder, M.D.||Washington University School of Medicine|