RECRUITING

Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study

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Conditions

Acute Myeloid Leukemia

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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 purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy.

Official Title

Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot

Quick Facts

Study Start:2024-05-02
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06323590

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 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult male or female, age ≥18
  2. 2. Patients with newly diagnosed AML (de novo or secondary), treated with intensive induction chemotherapy (7+3+/-3rd agent). The 3rd agent will be midostaurin for FLT3-mutant AML or gemtuzumab ozogamicin for core-binding factor AML. Patients on clinical trial with an investigational agent added to 7+3, may be enrolled on the protocol after discussion between the investigators and medical monitors.
  3. 3. Prior use of hypomethylating agents, lenalidomide, erythropoiesis stimulating agents and growth factors as allowed for treatment of myelodysplastic syndrome. Prior treatment for AML is not allowed.
  4. 4. Cardiac function: Ejection fraction \>50-55%
  5. 5. Adequate organ function for receipt for induction chemotherapy
  6. 6. Patients with HIV and Hepatitis B or C should have controlled disease.
  7. 7. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment.
  1. 1. Any other active malignancy requiring treatment or with expected survival ≤1 year.
  2. 2. Recipients of prior allogeneic stem cell transplant.
  3. 3. Patients with psychiatric illness or social situation that would limit compliance with the study requirements.
  4. 4. Patients with active CNS disease
  5. 5. Patients with APL
  6. 6. Received any investigational drugs within the 14 days prior to the first day of induction
  7. 7. Pregnant and/or breastfeeding

Contacts and Locations

Study Contact

Omer Jamy, MD
CONTACT
2059342721
omerjamy@uabmc.edu
Omer Jamy
CONTACT
2059342721
omerjamy@uabmc.edu

Principal Investigator

Omer Jamy
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Omer Jamy, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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 Date2024-05-02
Study Completion Date2028-05

Study Record Updates

Study Start Date2024-05-02
Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia