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

Recruiting now

Conditions studied: Acute Leukemia, Newly Diagnosed, Relapsed

In brief

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.

Key facts

Study ID

NCT02677064

Run by

Memorial Sloan Kettering Cancer Center

People needed

1365

Starts

2016-02-01

Expected to finish

2027-02-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Hartford Healthcare Cancer Institute @ Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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