Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
Recruiting
Observational Study
Acute LeukemiaNewly DiagnosedRelapsed
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Observational
Participants needed
1,365 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for patients with newly diagnosed or relapsed acute leukemia. It aims to understand the reasons some patients receive stem cell transplants while others do not.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with newly diagnosed or relapsed acute leukemia.
I am 18 to 80 years old.
I have undergone reinduction due to primary induction failure.
I have evidence of disease progression or no response to previous treatments.
I am experiencing a relapse after my first allograft.
You may not be able to join if
I have polycythemia vera.
I have essential thrombocytosis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Eligibility 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 fo…
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)
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