CLLPhase 2CORALNCT05209308
Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL
A Phase 2 study testing Zandelisib, Rituximab and Venetoclax in people with CLL, run by MEI Pharma, Inc. at 4 sites in United States.
Trial summary
A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory CLL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL
- What is being tested?
- Zandelisib, Rituximab and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Nov 2022to 15 Mar 2023
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥18 years
- Histologically confirmed relapsed/refractory CLL who received ≥1 lines of prior therapy
- At least one bi-dimensionally measurable nodal lesion >1.5 cm
- Adequate renal, hepatic function
- Adequate hematologic parameters at screening
Who cannot join
- Subjects who relapsed or progressed on BCL-2 inhibitor
- Relapsed within 2 years of discontinuation of prior PI3K inhibitor (PI3Ki) therapy or disease progression on PI3Ki therapy
- History or currently active HBV, HCV; any uncontrolled active infection, HIV infection; HIV-related lymphoma
- History of Richter's transformation or prolymphocytic leukemia
- Known allergies to both xanthine oxidase inhibitors and rasburicase, or any excipients of the drug products
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure
- Pregnant women
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, 99208
Stony Brook University
Stony Brook, New York, 11794
About this study
Official title: A Phase 2 Single-Arm, Open-Label Study to Assess the Safety and Efficacy of Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - The CORAL Study
A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory CLL.
Read the detailed description
This is an open label Phase 2 clinical study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with R/R CLL.
VEN and R will be administered per standard of care.
Subjects must have histologically confirmed relapsed/refractory CLL and received ≥1 lines of prior therapy
A total 42 subjects will be enrolled and treated with zandelisib in combination with VEN + R.
- Conditions
- CLL
- Being tested
- Zandelisib, Rituximab, Venetoclax
- Keywords
- Leukemia
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZandelisibDrug
Also called ME-401
Zandelisib taken orally for 7 days of each 28 day cycle
RituximabDrug
Also called Rituxan, MabThera
Rituximab IV for 6 cycles
VenetoclaxDrug
Also called Venclexta
Orally - Ramp up weeks 1-5
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Ven "low dose" + Rituximab + Zandelisib Receives: Drug: Zandelisib; Drug: Rituximab; Drug: Venetoclax |
| Cohort B | Experimental | Ven "standard dose" + Rituximab + Zandelisib Receives: Drug: Zandelisib; Drug: Rituximab; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the uMRD rate in PB and BM by flow cytometry
measured by 8-color flow cytometry with a quantitative lower limit of detection of at least 10-4 (1 in 10,000 cells).
Measured: 2 year
Secondary outcomes (2)
ORR
The ORR will be measured by the proportion of subjects having achieved a CR/CRi (CR with incomplete recovery in BM) or partial response (PR) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (2018)
Measured: 2 years
Progression Free Survival
PFS will be measured as the time from first dose date until progression according the iwCLL criteria or death from any cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start22 Nov 2022
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Why it stopped: Discontinuation of zandelisib development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLLStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This open label study is composed of 2 cohorts: A safety run-in Cohort A followed by Cohort B. Both cohorts will follow the same dosing schedule and subjects will receive Zandelisib, however in Cohort A, VEN will be administered at a different dose then Cohort B.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEI Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209308
- Sponsor's protocol ID
- ME-401-008
- Acronym
- CORAL
- Status last verified
- Mar 2023
- First submitted
- 12 Jan 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Single-Arm, Open-Label Study to Assess the Safety and Efficacy of Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - The CORAL Study
- ClinicalTrials.gov ID
- NCT05209308
- Acronym / sponsor ID
- CORAL / ME-401-008
- Conditions
- CLL
- Keywords
- Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Discontinuation of zandelisib development
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MEI Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Kirin, Inc.
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 26 Jan 2022 (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 Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory CLL.
Detailed description
This is an open label Phase 2 clinical study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with R/R CLL.
VEN and R will be administered per standard of care.
Subjects must have histologically confirmed relapsed/refractory CLL and received ≥1 lines of prior therapy
A total 42 subjects will be enrolled and treated with zandelisib in combination with VEN + R.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This open label study is composed of 2 cohorts: A safety run-in Cohort A followed by Cohort B. Both cohorts will follow the same dosing schedule and subjects will receive Zandelisib, however in Cohort A, VEN will be administered at a different dose then Cohort B.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Zandelisib, Drug: Rituximab, Drug: VenetoclaxVen "low dose" + Rituximab + Zandelisib |
| Cohort B | Experimental | Drug: Zandelisib, Drug: Rituximab, Drug: VenetoclaxVen "standard dose" + Rituximab + Zandelisib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females ≥18 years
- Histologically confirmed relapsed/refractory CLL who received ≥1 lines of prior therapy
- At least one bi-dimensionally measurable nodal lesion >1.5 cm
- Adequate renal, hepatic function
- Adequate hematologic parameters at screening
Key exclusion criteria (7 listed)
- Subjects who relapsed or progressed on BCL-2 inhibitor
- Relapsed within 2 years of discontinuation of prior PI3K inhibitor (PI3Ki) therapy or disease progression on PI3Ki therapy
- History or currently active HBV, HCV; any uncontrolled active infection, HIV infection; HIV-related lymphoma
- History of Richter's transformation or prolymphocytic leukemia
- Known allergies to both xanthine oxidase inhibitors and rasburicase, or any excipients of the drug products
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 |
|---|---|---|
| ZandelisibAlso: ME-401Zandelisib taken orally for 7 days of each 28 day cycle | Drug | Cohort A, Cohort B |
| RituximabAlso: Rituxan, MabTheraRituximab IV for 6 cycles | Drug | Cohort A, Cohort B |
| VenetoclaxAlso: VenclextaOrally - Ramp up weeks 1-5 | Drug | Cohort A, Cohort B |
Primary outcome
To determine the uMRD rate in PB and BM by flow cytometry
Time frame: 2 year
measured by 8-color flow cytometry with a quantitative lower limit of detection of at least 10-4 (1 in 10,000 cells).
2 secondary outcomes
ORR
Time frame: 2 years
Progression Free Survival
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zandelisib, Rituximab and Venetoclax in people with CLL, run by MEI Pharma, Inc. at 4 sites in United States.
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 7 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: withdrawn, as of the sponsor's last update on 16 Mar 2023. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the uMRD rate in PB and BM by flow cytometry (time frame: 2 year). 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 16 Mar 2023.