Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
NCT ID: NCT02677064
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1365 participants
OBSERVATIONAL
2016-02-29
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with Acute Leukemia or MDS/MPN who Relapse After First Allografts (Arm C)
Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
assessments
All laboratory assessments performed on this study represent standard of care at our institution. HLA allele typing is performed by the center's HLA laboratory according to standard typing procedures.
Patients with MDS and MPN (Arm B)
Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
assessments
All laboratory assessments performed on this study represent standard of care at our institution. HLA allele typing is performed by the center's HLA laboratory according to standard typing procedures.
Patients with Acute Leukemia (Arm A)
Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
assessments
All laboratory assessments performed on this study represent standard of care at our institution. HLA allele typing is performed by the center's HLA laboratory according to standard typing procedures.
Interventions
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assessments
All laboratory assessments performed on this study represent standard of care at our institution. HLA allele typing is performed by the center's HLA laboratory according to standard typing procedures.
Eligibility Criteria
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Inclusion Criteria
* Patients with diagnosis of MDS, MPN and MDS/MPN overlap who meet any of the following criteria (based on NCCN guidelines):
* Clinically significant cytopenia of at least 2 cell lines affected; Hgb\<10,
* Platelet\<100,000, absolute neutrophil count\<1000
* Bone marrow blasts \>5% and any level of circulating blasts
* Evidence of disease progression or no response to hypomethylating agents/immunosuppressive treatment or a clinical trial.
* IPSS Intermediate-1 and higher
* IPSS-R intermediate and higher
* All cases of therapy related MDS with excess blasts
* In patients with Myelofibrosis: Low risk disease by DIPSS with either refractory, transfusion dependent anemia, circulating blasts cells greater than 2%; or adverse cytogenetics and any patient with DIPSS-intermidiate 1 and higher.
* Patients with acute leukemia or MDS/MPN who relapse after first allografts. Patients with post-transplant relapse will be enrolled to Arm C.
* Patients 18 years of age or older and 80 years of age or younger
* For the purposes of this protocol "relapse" is defined as re-emergence of the initial abnormal myeloid blast population (or blast equivalent) comprising 5% or more of marrow WBC or any amount prompting a therapeutic intervention targeting relapsed disease, including, but not limited to withdrawal of immunosuppression, targeted therapies, chemotherapy, etc.
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Roni Tamari, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Mark Dailey, MD
Role: primary
Roni Tamari, MD
Role: primary
Sergio Giralt, MD
Role: backup
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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16-024
Identifier Type: -
Identifier Source: org_study_id