Understanding barriers to stem cell transplantation in acute leukemia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the percentage of patients with newly diagnosed or relapsed acute leukemia who receive allogeneic hematopoietic stem cell transplantation. The researchers will investigate the reasons why some patients undergo transplantation while others do not, including those who choose not to proceed despite recommendations from their physicians. The study will also include patients with myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN) to explore similar barriers. Data will be collected through assessments at participating institutions.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hartford Healthcare Cancer Institute @ Hartford Hospital
  Hartford, Connecticut, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Lehigh Valley Health Network
  Allentown, Pennsylvania, United States Active not recruiting

Study contacts

• Principal investigator: Roni Tamari, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Roni Tamari, MD
• Email: ABMTTrials@mskcc.org

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.