Understanding barriers to stem cell transplantation in acute leukemia patients
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
This study looks at why some patients with acute leukemia, myelodysplastic syndromes, or myeloproliferative neoplasms choose to have or skip stem cell transplants, even when their doctors recommend it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1365 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Hartford, Connecticut and 2 other locations) |
| Trial ID | NCT02677064 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with newly diagnosed or relapsed acute leukemia, as well as those with MDS or MPN meeting specific clinical criteria.
Not a fit: Patients with conditions unrelated to acute leukemia, MDS, or MPN, or those who are not eligible for stem cell transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and strategies to increase the rates of stem cell transplantation in acute leukemia patients.
How similar studies have performed: Other studies have explored barriers to transplantation in hematologic malignancies, suggesting that this approach has been previously validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Hartford, Connecticut and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.