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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Leukemia; Newly Diagnosed; Relapsed
• Intervention / Treatment: Other: assessments

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 1365

Contacts and Locations

• Study Contact: Name: Roni Tamari, MD; Email: ABMTTrials@mskcc.org
• Study Contact Backup: Name: Sergio Giralt, MD; Email: ABMTTrials@mskcc.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Healthcare Cancer Institute @ Hartford Hospital
      • Contact: Mark Dailey, MD; Phone Number: (860) 249-6291
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Roni Tamari, MD; Email: ABMTTrials@mskcc.org
      • Contact: Sergio Giralt, MD; Email: ABMTTrials@mskcc.org
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Active, not recruiting
      • Lehigh Valley Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute leukemia and MDS or MPN who are treated inpatient or outpatient by the Leukemia Service for induction or re-induction therapy (acute leukemia) or initiation of therapy (for MDS or MPN) will be seen by the Adult BMT Service.

Description

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-intermediate 1 and higher. For patients with post-PV and post-ET myelofibrosis, any patient with MYSEC-PM Intermediate-1 risk or higher is eligible.
• 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.
• Patients previously enrolled in Arm A or Arm B who experience post-transplant relapse are also eligible for enrollment onto Arm C

Exclusion Criteria:

• Patients with polycythemia vera (PV) and essential thrombocytosis (ET)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Roni Tamari, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimated): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Allogeneic Hematopoietic Stem Cell Transplantation; Identify Barriers; 16-024
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: 16-024 (HMR Protocol Code)