Acute LeukemiaNCT02677064
Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
An observational study of Acute Leukemia and Newly Diagnosed, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Leukemia, Newly Diagnosed, Relapsed
- What is being tested?
- assessments
- How many people
- 1,365 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2016to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 14Show fewer
- 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
Who cannot join
- Patients with polycythemia vera (PV) and essential thrombocytosis (ET)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Roni Tamari, MD contact
Sergio Giralt, MD contact
United States3 sites, 2 recruiting
- Active, not recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
- Recruiting
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102
Mark Dailey, MD, (860) 249-6291
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Roni Tamari, MD, ABMTTrials@mskcc.org
Sergio Giralt, MD, ABMTTrials@mskcc.org
About this study
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
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.
Read the 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
- Conditions
- Acute Leukemia, Newly Diagnosed, Relapsed
- Being tested
- assessments
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Identify Barriers, 16-024
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Acute Leukemia (Arm A) | Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible. Receives: Other: assessments | |
| Patients with MDS and MPN (Arm B) | Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible. Receives: Other: assessments | |
| Patients with Acute Leukemia or MDS/MPN who Relapse After First Allografts (Arm C) | Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible. Receives: Other: assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who proceed to transplant
determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roni Tamari, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677064
- Sponsor's protocol ID
- 16-024
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2016
- Last updated
- 24 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02677064
- Acronym / sponsor ID
- 16-024
- Conditions
- Acute Leukemia, Newly Diagnosed, Relapsed
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Identify Barriers, 16-024
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,365 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Acute Leukemia (Arm A) | – | Other: assessmentsFollow 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) | – | Other: assessmentsFollow 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 or MDS/MPN who Relapse After First Allografts (Arm C) | – | Other: assessmentsFollow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with polycythemia vera (PV) and essential thrombocytosis (ET)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessmentsAll 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. | Other | Patients with Acute Leukemia (Arm A), Patients with Acute Leukemia or MDS/MPN who Relapse After First Allografts (Arm C), Patients with MDS and MPN (Arm B) |
Primary outcome
number of patients who proceed to transplant
Time frame: 3 years
determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roni Tamari, MD contact
Sergio Giralt, MD contact
Roni Tamari, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia and Newly Diagnosed, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roni Tamari, MD (ABMTTrials@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients who proceed to transplant (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.