Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT02677064

Conditions

Acute Leukemia

Newly Diagnosed

Relapsed

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

assessments

Study Details

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.

Conditions

Acute Leukemia

Newly Diagnosed

Relapsed

Study ID

NCT02677064

Start date

Feb, 2016

Status verified date

Jul, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

1365 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

assessments

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.

Primary outcome measure

  • number of patients who proceed to transplant [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Roni Tamari, MD

ABMTTrials@mskcc.org

Sergio Giralt, MD

ABMTTrials@mskcc.org

Locations

Hartford Healthcare Cancer Institute @ Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Mark Dailey, MD

(860) 249-6291

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Roni Tamari, MD

ABMTTrials@mskcc.org

Sergio Giralt, MD

ABMTTrials@mskcc.org

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Identify Barriers
  • 16-024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-24.