Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Observational Study to Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia, Myelodysplastic Syndrome and Myelproliferative Neoplasms

Conditions
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Acute Leukemia, Newly Diagnosed, Relapsed

Intervention / Treatment
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* Other: assessments


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Acute Leukemia (Arm A)<br>Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible. | Other: assessments<br>* 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.<br>|
| Patients with MDS and MPN (Arm B)<br>Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible. | Other: assessments<br>* 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.<br>|
| Patients with Acute Leukemia or MDS/MPN who Relapse After First Allografts (Arm C)<br>Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible. | Other: assessments<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allogeneic Hematopoietic Stem Cell Transplantation, Identify Barriers, 16-024