Hematologic MalignanciesPhase 1NCT03557619
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
A Phase 1 study testing Venetoclax and ethinyl estradiol/levonorgestrel in people with Hematologic Malignancies, run by AbbVie at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Venetoclax and ethinyl estradiol/levonorgestrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Jul 2019to 21 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
- Completed
Gabrail Cancer Center Research /ID# 207039
Canton, Ohio, 44718
- Completed
Duplicate_Henry Ford Health System /ID# 209090
Detroit, Michigan, 48202
- Completed
Dartmouth-Hitchcock Medical Center /ID# 169097
Lebanon, New Hampshire, 03756
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre-East Melbourne /ID# 225247
East Melbourne, Victoria, 3002
About this study
Official title: A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies
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.
- Conditions
- Hematologic Malignancies
- Being tested
- Venetoclax, ethinyl estradiol/levonorgestrel
- Keywords
- Cancer, Hematologic Malignancies, venetoclax, ethinyl estradiol, relapsed or refractory non-Hodgkin's lymphoma, non-Hodgkin's lymphoma
- Medical subject headings
- Hematologic Neoplasms, Neoplasms, Recurrence, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called ABT-199, GDC-0199, Venclexta
tablet; oral
ethinyl estradiol/levonorgestrelDrug
Also called Levora
tablet; oral
| Study group | Role | What they receive |
|---|---|---|
| Ethinyl estradiol/Levonorgestrel and Venetoclax | Experimental | 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. Receives: Drug: Venetoclax; Drug: ethinyl estradiol/levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax of Venetoclax
Time to maximum plasma concentration (Tmax) of Venetoclax.
Measured: Up to approximately 59 days after initial study drug dose
Tmax of (ethinyl estradiol) EE/Levonorgestrel
Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel
Measured: Up to approximately 59 days after initial study drug dose
Cmax of Venetoclax
Maximum plasma concentration (Cmax) of Venetoclax
Measured: Up to approximately 59 days after initial study drug dose
Cmax of EE/Levonorgestrel
Maximum plasma concentration (Cmax) of EE/Levonorgestrel
Measured: Up to approximately 59 days after initial study drug dose
t1/2 of Venetoclax
Terminal phase elimination half-life (t1/2) of Venetoclax.
Measured: Up to approximately 59 days after initial study drug dose
t1/2 of EE/Levonorgestrel
Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel
Measured: Up to approximately 59 days after initial study drug dose
AUCt of Venetoclax
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of Venetoclax
Measured: Up to approximately 59 days after initial study drug dose
AUCt of EE/Levonorgestrel
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of EE/Levonorgestrel
Measured: Up to approximately 59 days after initial study drug dose
AUCinf of EE/Levonorgestrel
AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel.
Measured: Up to approximately 59 days after initial study drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start30 Jul 2019
- Primary completion21 Mar 2026 (estimated)
- Study completion21 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557619
- Sponsor's protocol ID
- M16-185
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2018
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT03557619
- Acronym / sponsor ID
- M16-185
- Conditions
- Hematologic Malignancies
- Keywords
- Cancer, Hematologic Malignancies, venetoclax, ethinyl estradiol, relapsed or refractory non-Hodgkin's lymphoma, non-Hodgkin's lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 21 Mar 2026 (estimated)
- Study completion
- 21 Mar 2026 (estimated)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ethinyl estradiol/Levonorgestrel and Venetoclax | Experimental | Drug: Venetoclax, Drug: ethinyl estradiol/levonorgestrelEthinyl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxAlso: ABT-199, GDC-0199, Venclextatablet; oral | Drug | Ethinyl estradiol/Levonorgestrel and Venetoclax |
| ethinyl estradiol/levonorgestrelAlso: Levoratablet; oral | Drug | Ethinyl estradiol/Levonorgestrel and Venetoclax |
Primary outcome
Tmax of Venetoclax
Time frame: Up to approximately 59 days after initial study drug dose
Time to maximum plasma concentration (Tmax) of Venetoclax.
Tmax of (ethinyl estradiol) EE/Levonorgestrel
Time frame: Up to approximately 59 days after initial study drug dose
Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel
Cmax of Venetoclax
Time frame: Up to approximately 59 days after initial study drug dose
Maximum plasma concentration (Cmax) of Venetoclax
Cmax of EE/Levonorgestrel
Time frame: Up to approximately 59 days after initial study drug dose
Maximum plasma concentration (Cmax) of EE/Levonorgestrel
t1/2 of Venetoclax
Time frame: Up to approximately 59 days after initial study drug dose
Terminal phase elimination half-life (t1/2) of Venetoclax.
t1/2 of EE/Levonorgestrel
Time frame: Up to approximately 59 days after initial study drug dose
Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel
AUCt of Venetoclax
Time frame: Up to approximately 59 days after initial study drug dose
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of Venetoclax
AUCt of EE/Levonorgestrel
Time frame: Up to approximately 59 days after initial study drug dose
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of EE/Levonorgestrel
AUCinf of EE/Levonorgestrel
Time frame: Up to approximately 59 days after initial study drug dose
AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venetoclax and ethinyl estradiol/levonorgestrel in people with Hematologic Malignancies, run by AbbVie at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tmax of Venetoclax (time frame: Up to approximately 59 days after initial study drug dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.