Clinical trial NCT02677064: Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Leukemia
Newly Diagnosed
Relapsed
Keywords: Allogeneic Hematopoietic Stem Cell Transplantation
Identify Barriers
16-024
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 1365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute leukemia and MDS or MPN who are treated inpatient or outpatient by the Leukemia Service for induction or re-induction therapy (acute leukemia) or initiation of therapy (for MDS or MPN) will be seen by the Adult BMT Service.

Brief 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.

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

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-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 Criteria:

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

Primary outcomes:
measure: number of patients who proceed to transplant
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare Cancer Institute @ Hartford Hospital
state: Connecticut
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Roni Tamari, MD
role: PRINCIPAL_INVESTIGATOR
References: