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NCT Number: NCT02677064

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford, Connecticut, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Assessments

Other

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 outcomes

  1. number of patients who proceed to transplant

    Time frame: 3 years

    determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines.

Study contacts

Contact information is provided by the study sponsor or research team.

Roni Tamari, MD

CONTACT

[email protected]

Sergio Giralt, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2016
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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