RECRUITING

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

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Conditions

Acute LeukemiaNewly DiagnosedRelapsedAllogeneic Hematopoietic Stem Cell TransplantationIdentify Barriers16-024

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2016-02
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02677064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Patients with diagnosis of MDS, MPN and MDS/MPN overlap who meet any of the following criteria (based on NCCN guidelines):
  3. * Clinically significant cytopenia of at least 2 cell lines affected; Hgb\<10,
  4. * Platelet\<100,000, absolute neutrophil count\<1000
  5. * Bone marrow blasts \>5% and any level of circulating blasts
  6. * Evidence of disease progression or no response to hypomethylating agents/immunosuppressive treatment or a clinical trial.
  7. * IPSS Intermediate-1 and higher
  8. * IPSS-R intermediate and higher
  9. * All cases of therapy related MDS with excess blasts
  10. * 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.
  11. * Patients with acute leukemia or MDS/MPN who relapse after first allografts. Patients with post-transplant relapse will be enrolled to Arm C.
  12. * Patients 18 years of age or older and 80 years of age or younger
  13. * 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.
  1. * Patients with polycythemia vera (PV) and essential thrombocytosis (ET)

Contacts and Locations

Study Contact

Roni Tamari, MD
CONTACT
ABMTTrials@mskcc.org
Sergio Giralt, MD
CONTACT
ABMTTrials@mskcc.org

Principal Investigator

Roni Tamari, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Roni Tamari, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-02
Study Completion Date2025-02

Study Record Updates

Study Start Date2016-02
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Acute Leukemia
  • Newly Diagnosed
  • Relapsed