RecruitingNCT02677064

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

1,365 participants

Start Date

Feb 1, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria13

  • 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-intermidiate 1 and higher.
  • 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.

Exclusion Criteria1

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

Interventions

OTHERassessments

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.


Locations(3)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

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NCT02677064


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