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Recruiting NCT02677064

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

— Observational Acute Leukemia Newly Diagnosed Relapsed

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: assessments.
Who it may be relevant to
Registry conditions: Acute Leukemia, Newly Diagnosed, Relapsed. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other assessments
    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.

Primary outcome measures

  • number of patients who proceed to transplant [Time frame: 3 years]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • Hartford Healthcare Cancer Institute @ Hartford Hospital — Hartford
  • Memorial Sloan Kettering Cancer Center — New York
  • Lehigh Valley Health Network — Allentown

Identifiers

NCT: NCT02677064 · 16-024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗