RECRUITING

A Study of BGB-11417 in Participants With Myeloid Malignancies

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 study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

Official Title

A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies

Quick Facts

Study Start:2021-05-24
Study Completion:2028-02-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04771130

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
  2. * AML, nonacute promyelocytic leukemia
  3. * MDS
  4. * MDS/MPN
  5. 2. Eastern Cooperative Oncology Group performance status of 0 to 2.
  6. 3. Adequate organ function defined as:
  7. * Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)
  8. * Adequate liver function
  9. 4. Life expectancy of \> 12 weeks.
  10. 5. Ability to comply with the requirements of the study.
  1. 1. A diagnosis of acute promyelocytic leukemia.
  2. 2. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)
  3. 3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
  4. 4. Prior therapy with a B-cell lymphoma-2 inhibitor
  5. 5. Known central nervous system involvement by leukemia.

Contacts and Locations

Study Contact

BeiGene
CONTACT
1.877.828.5568
clinicaltrials@beigene.com

Study Locations (Sites)

City of Hope National Medical Center
Duarte, California, 91010
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Maryland Oncology Hematology, Pa
Columbia, Maryland, 21044
United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, 15232
United States
Md Anderson Cancer Center
Houston, Texas, 77030
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: BeiGene

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 Date2021-05-24
Study Completion Date2028-02-08

Study Record Updates

Study Start Date2021-05-24
Study Completion Date2028-02-08

Terms related to this study

Keywords Provided by Researchers

  • BGB-11417
  • Azacitidine
  • Posaconazole
  • AML
  • MDS
  • MDS/MPN

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasm