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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how many patients with certain blood cancers get a stem cell transplant from a donor. It explores why some patients get a transplant and others do not, including why some choose not to have one when their doctor recommends it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 80 years old.
  • Have acute leukemia, a fast-growing blood cancer, that is newly diagnosed or has come back. Patients getting treatment again because their first treatment did not work may also join.
  • Have MDS, MPN, or an overlap of these bone marrow diseases and meet at least one of the study’s disease rules described below.
  • For MDS or MPN: have low counts in at least two blood cell types—hemoglobin below 10, platelets below 100,000, or neutrophils (infection-fighting cells) below 1,000.
  • Other qualifying MDS or MPN findings include more than 5% blasts (immature blood cells) in bone marrow with blasts in the blood; worsening disease; or no response to the listed medicines or a clinical trial.
  • Other qualifying MDS findings include an IPSS risk score of intermediate-1 or higher, an IPSS-R score of intermediate or higher, or MDS caused by prior treatment with excess immature blood cells.
  • For myelofibrosis, a disease that scars bone marrow: have a DIPSS risk score of intermediate-1 or higher, or low-risk disease with hard-to-treat anemia needing blood transfusions, more than 2% immature cells in the blood, or harmful chromosome changes. If it developed after PV or ET, have a MYSEC-PM risk score of intermediate-1 or higher.
  • Patients whose acute leukemia or MDS/MPN came back after their first donor transplant may join Arm C. This includes patients previously in Arm A or B. Return of disease means at least 5% abnormal immature cells in the bone marrow, or any amount that leads to treatment for the returning disease.

Who can't join

  • Have polycythemia vera (PV), which causes too many red blood cells, or essential thrombocytosis (ET), which causes too many platelets.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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)

Study sites (3)

CT

NY

PA