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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03557619




Registration number
NCT03557619
Ethics application status
Date submitted
5/06/2018
Date registered
15/06/2018
Date last updated
18/11/2023

Titles & IDs
Public title
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
Scientific title
A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies
Secondary ID [1] 0 0
M16-185
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematologic Malignancies 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Venetoclax
Treatment: Drugs - ethinyl estradiol/levonorgestrel

Experimental: Ethinyl estradiol/Levonorgestrel and Venetoclax - Ethinyl estradiol/levonorgestrel is administered on Period 1 Day 1 and then again on Period 3 Day 1. Venetoclax is administered on Period 2 Day 1 and then daily thereafter.


Treatment: Drugs: Venetoclax
tablet; oral

Treatment: Drugs: ethinyl estradiol/levonorgestrel
tablet; oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tmax of Venetoclax
Timepoint [1] 0 0
Up to approximately 59 days after initial study drug dose
Primary outcome [2] 0 0
Tmax of (ethinyl estradiol) EE/Levonorgestrel
Timepoint [2] 0 0
Up to approximately 59 days after initial study drug dose
Primary outcome [3] 0 0
Cmax of Venetoclax
Timepoint [3] 0 0
Up to approximately 59 days after initial study drug dose
Primary outcome [4] 0 0
Cmax of EE/Levonorgestrel
Timepoint [4] 0 0
Up to approximately 59 days after initial study drug dose
Primary outcome [5] 0 0
t1/2 of Venetoclax
Timepoint [5] 0 0
Up to approximately 59 days after initial study drug dose
Primary outcome [6] 0 0
t1/2 of EE/Levonorgestrel
Timepoint [6] 0 0
Up to approximately 59 days after initial study drug dose
Primary outcome [7] 0 0
AUCt of Venetoclax
Timepoint [7] 0 0
Up to approximately 59 days after initial study drug dose
Primary outcome [8] 0 0
AUCt of EE/Levonorgestrel
Timepoint [8] 0 0
Up to approximately 59 days after initial study drug dose
Primary outcome [9] 0 0
AUCinf of EE/Levonorgestrel
Timepoint [9] 0 0
Up to approximately 59 days after initial study drug dose

Eligibility
Key inclusion criteria
- Participant must have relapsed or refractory non-Hodgkin's lymphoma (NHL).

- 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)

- Has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or
equal to two.

- Must have adequate bone marrow, coagulation, renal and hepatic function as described
in the protocol.

- A female of non-childbearing potential as described in the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of currently active, clinically significant cardiovascular disease.

- 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.

- evidence of transformation of the lymphoma immediately prior to study entry.

- Evidence of central nervous system involvement by lymphoma.

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/03/2024
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre-East Melbourne /ID# 225247 - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
New Hampshire
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03557619
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03557619