RECRUITING

A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological 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

A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study.

Official Title

A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies

Quick Facts

Study Start:2019-07-30
Study Completion:2026-03-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03557619

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must have relapsed or refractory non-Hodgkin's lymphoma (NHL).
  2. * Participant must have histologically documented diagnosis of one of the following NHL subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), T-cell prolymphocytic lymphoma (T-PLL), Waldenström's macroglobulinemia (WM)
  3. * Has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to two.
  4. * Must have adequate bone marrow, coagulation, renal and hepatic function as described in the protocol.
  5. * A female of non-childbearing potential as described in the protocol.
  1. * History of currently active, clinically significant cardiovascular disease.
  2. * If the participant has had prior stem cell transplantation, it must have been more than 100 days prior to start of study drug, with no graft versus host disease, and no immunosuppression therapy.
  3. * evidence of transformation of the lymphoma immediately prior to study entry.
  4. * Evidence of central nervous system involvement by lymphoma.

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Duplicate_Henry Ford Health System /ID# 209090
Detroit, Michigan, 48202
United States
Dartmouth-Hitchcock Medical Center /ID# 169097
Lebanon, New Hampshire, 03756
United States
Gabrail Cancer Center Research /ID# 207039
Canton, Ohio, 44718
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

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 Date2019-07-30
Study Completion Date2026-03-21

Study Record Updates

Study Start Date2019-07-30
Study Completion Date2026-03-21

Terms related to this study

Keywords Provided by Researchers

  • Cancer
  • Hematologic Malignancies, venetoclax
  • ethinyl estradiol
  • relapsed or refractory non-Hodgkin's lymphoma
  • non-Hodgkin's lymphoma

Additional Relevant MeSH Terms

  • Hematologic Malignancies