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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Acute Leukemia; Newly Diagnosed; Relapsed

Treatments: Other: assessments

Study type: Observational

Funder types: Other

Identifiers

NCT02677064

16-024

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,365 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,365 participants in 3 patient groups

Patients with Acute Leukemia (Arm A)

Description:

Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.

Treatment:

Other: assessments

Patients with MDS and MPN (Arm B)

Description:

Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.

Treatment:

Other: assessments

Patients with Acute Leukemia or MDS/MPN who Relapse After First Allografts (Arm C)

Description:

Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.

Treatment:

Other: assessments