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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02677064
Enrollment
1365
Registered
2016-02-09
Start date
2016-02-01
Completion date
2027-02-01
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Newly Diagnosed, Relapsed

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation, Identify Barriers, 16-024

Brief 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.

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

Interventions

OTHERassessments

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
number of patients who proceed to transplant3 yearsdetermine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines.

Countries

United States

Contacts

CONTACTRoni Tamari, MD
ABMTTrials@mskcc.org
CONTACTSergio Giralt, MD
ABMTTrials@mskcc.org
PRINCIPAL_INVESTIGATORRoni Tamari, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026