NCT02677064 Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
| NCT ID | NCT02677064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Acute Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,365 participants |
| Start Date | 2016-02 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,365 participants in total. It began in 2016-02 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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-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)
Contact & Investigator
Roni Tamari, MD
✉ ABMTTrials@mskcc.orgRoni Tamari, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT02677064 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02677064 currently recruiting?
Yes, NCT02677064 is actively recruiting participants. Contact the research team at ABMTTrials@mskcc.org for enrollment information.
Where is the NCT02677064 trial being conducted?
This trial is being conducted at Hartford, United States, New York, United States, Allentown, United States.
Who is sponsoring the NCT02677064 clinical trial?
NCT02677064 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Roni Tamari, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 1,365 participants.
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