Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
- Conditions
- RelapsedAcute LeukemiaNewly Diagnosed
- Interventions
- Other: assessments
- Registration Number
- NCT02677064
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1365
- 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.
- Patients with polycythemia vera (PV) and essential thrombocytosis (ET)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Acute Leukemia or MDS/MPN who Relapse After First Allografts (Arm C) assessments Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible. Patients with Acute Leukemia (Arm A) assessments Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible. Patients with MDS and MPN (Arm B) assessments Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
- Primary Outcome Measures
Name Time Method number of patients who proceed to transplant 3 years determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Hartford Healthcare Cancer Institute @ Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States