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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02677064
Other study ID # 16-024
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2016
Est. completion date February 2025

Study information

Verified date November 2023
Source Memorial Sloan Kettering Cancer Center
Contact Boglarka Gyurkocza, MD
Email ABMTTrials@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators are doing this research study to assess the percentage of patients receiving stem cell transplantation for the type of blood cancer you have. They want to know how many patients get a transplant and why some patients do get a transplant while others do not. Also they want to explore why some patients elect not to undergo stem cell transplantation, when it is recommended by their physicians.


Description:

Additional Arms have been added for MSK patients only. Patients with MDS and MPN Patients with Post-transplant Relapse of Acute Leukemia, MDS or MPN


Recruitment information / eligibility

Status Recruiting
Enrollment 1365
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients with newly diagnosed or relapsed acute leukemia. Patients undergoing reinduction due to primary induction failure are also eligible. Patients with acute leukemia will be enrolled to Arm A - 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: - Patients with polycythemia vera (PV) and essential thrombocytosis (ET)

Study Design


Intervention

Other:
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.

Locations

Country Name City State
United States Lehigh Valley Health Network Allentown Pennsylvania
United States Hartford Healthcare Cancer Institute @ Hartford Hospital Hartford Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of patients who proceed to transplant determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines. 3 years
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