Chronic Lymphocytic Leukemia (CLL)Phase 1NCT03400176
VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
A Phase 1 study testing VAY736 and ibrutinib in people with Chronic Lymphocytic Leukemia (CLL), run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a dose expansion part. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL)
- What is being tested?
- VAY736 and ibrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Apr 2018to 29 Sep 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CLL per the WHO classification
- At least 18 years of age
- Lack of a complete response after receiving ibrutinib for > 1 year OR presence of known ibrutinib resistance mutation
- Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)
Who cannot join
- Known history of HIV
- Active hepatitis B or C infection
- Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ohio ST Compr Cancer Ctr James Hosp
Columbus, Ohio, 43210
University of California San Diego - Moores Cancer Center
La Jolla, California, 92093-0658
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
SCRI Oncology Partners
Nashville, Tennessee, 37203
Uni of Utah Huntsman Cancer Inst
Salt Lake City, Utah, 84103
About this study
Official title: Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy
Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a dose expansion part.
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Being tested
- VAY736, ibrutinib
- Keywords
- Ibrutinib, VAY736, Chronic lymphocytic leukemia, CLL, Bruton's Tyrosine Kinase, BTK mutation
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAY736Drug
Experimental
ibrutinibDrug
Also called Imbruvica
Approved medication
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Increasing doses of VAY736 in combination with a fixed dose of ibrutinib. Receives: Drug: VAY736; Drug: ibrutinib |
| Dose expansion | Experimental | Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation. Receives: Drug: VAY736; Drug: ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1 (Escalation Only)
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of treatment with the combination of VAY736 and ibrutinib and meets the criteria defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Measured: 28 days
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.
AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.
All patients were followed for a 30-day safety follow-up period subsequent to completion of VAY736 therapy. No new AEs or SAEs were collected beyond the 30-day safety follow-up or during the efficacy follow up period.
Measured: From first dose of study treatment up to 30 days after the last dose of VAY736, up to approximately 8.8 months
Number of Participants With Dose Reductions and Dose Interruptions of VAY736
For patients who did not tolerate the protocol-specified dosing schedule of the study drugs, dose adjustments could be permitted in order to allow the patient to continue study treatment.
Measured: Up to 7.8 months
Number of Participants With Dose Reductions and Dose Interruptions of Ibrutinib
For patients who did not tolerate the protocol-specified dosing schedule of the study drugs, dose adjustments could be permitted in order to allow the patient to continue study treatment.
Measured: Up to 8.5 months
Dose Intensity of VAY736
Dose intensity of VAY736 was calculated as: Actual Cumulative dose (mg/kg) / (Duration of exposure in weeks/2)
Measured: Up to 7.8 months
Dose Intensity of Ibrutinib
Dose intensity of ibrutinib was calculated as: Actual Cumulative dose (mg) / (Duration of exposure in days)
Measured: Up to 8.5 months
Secondary outcomes (15)
CR or CRi Rate at C9 for Expansion Arm A and Arm B by Investigator Per IWCLL
Percentage of participants with Complete Response (CR) or Complete Response with Incomplete Marrow Recovery (CRi) by investigator assessment per International Working Group - Chronic Lymphocytic Leukemia (IWCLL) response criteria.
Measured: Cycle 9 Day 1 (C9). The duration of each cycle was 28 days.
Posterior Mean of CR or CRi Response Rate at C9 for Expansion Arm A and Arm B (Bayesian Analysis)
The rate of CR/CRi at C9 was analyzed for each expansion arm using a Bayesian modeling approach.
A minimally informative beta distribution was used as prior distribution with parameters a=0.25 and b=1. This assumed, a priori, that the response rate was 20%.
Values estimated from the model at Cycle 9 are presented in the table. Posterior geometric mean for CR/CRi rate and 90% credible intervals in each group are presented.
Measured: Cycle 9 Day 1 (C9). The duration of each cycle was 28 days.
Posterior Probability That the True CR or CRi Response Rate at C9 for Expansion Arm A and Arm B Falls in Pre-defined Activity Intervals (Bayesian Analysis)
The rate of CR/CRi at C9 was analyzed for each expansion arm using a Bayesian modeling approach.
A minimally informative beta distribution was used as prior distribution with parameters a=0.25 and b=1. This assumed, a priori, that the response rate was 20%.
Values estimated from the model at Cycle 9 are presented in the table. The posterior probability that the true CR/CRi rate falls in the activity intervals defined below is presented:
- [0, 20%) - clinically not meaningful
- [20%, 40%) - moderate clinical benefit
- [40%, 100%] - superior clinical benefit
Measured: Cycle 9 Day 1 (C9). The duration of each cycle was 28 days.
Overall Response Rate (ORR) Assessed by Investigator Per IWCLL in the Dose Escalation Part
Efficacy was based on local investigator assessment per International Working Group - Chronic Lymphocytic Leukemia (IWCLL) response criteria.
ORR per IWCLL is defined as the percentage of participants with a best overall response of Complete Response (CR), Complete Response with Incomplete Marrow Recovery (CRi) or Partial Response (PR).
Measured: Up to approximately 2.5 years
Overall Response Rate (ORR) Assessed by Investigator Per IWCLL in the Dose Expansion Part
Efficacy was based on local investigator assessment per International Working Group - Chronic Lymphocytic Leukemia (IWCLL) response criteria.
ORR per IWCLL is defined as the percentage of participants with a best overall response of Complete Response (CR), Complete Response with Incomplete Marrow Recovery (CRi) or Partial Response (PR).
Measured: Up to approximately 2.7 years
Time to Progression (TTP) in the Dose Escalation Part
Efficacy was based on local investigator assessment per International Working Group - Chronic Lymphocytic Leukemia (IWCLL) response criteria.
TTP is defined as the time from start of treatment to date of event which is defined as the first documented progression or death due to underlying cancer.
If a patient had not had an event, TTP was censored at the date of the last adequate disease assessment.
TTP was analyzed using Kaplan-Meier estimates.
Measured: Up to approximately 2.5 years
Time to Progression (TTP) in the Dose Expansion Part
Efficacy was based on local investigator assessment per International Working Group - Chronic Lymphocytic Leukemia (IWCLL) response criteria.
TTP is defined as the time from start of treatment to date of event which is defined as the first documented progression or death due to underlying cancer.
If a patient had not had an event, TTP was censored at the date of the last adequate disease assessment.
TTP was analyzed using Kaplan-Meier estimates.
Measured: Up to approximately 2.7 years
Percentage of Participants With Clearance of Ibrutinib Resistance Mutation During Treatment (up to C9) for Expansion Arm B
Clearance was defined as less than 1% mutation bearing alleles (BTKC481 and/or PLCγ2) during treatment.
Negative mutation is defined as having clearance of the baseline ibrutinib resistance mutation during treatment (up to Cycle 9 (C9)).
Measured: Up to Cycle 9 Day 1. The duration of each cycle was 28 days.
Maximum Observed Serum Concentration (Cmax) of VAY736
Pharmacokinetic (PK) parameters were calculated based on VAY736 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.
Measured: Pre-infusion and 2, 6, 24, 72, 168 and 336 hours after end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was approximately 2 hours. 1 cycle=28 days
Time to Reach Maximum Serum Concentration (Tmax) of VAY736
PK parameters were calculated based on VAY736 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) concentration following a dose. Actual recorded sampling times were considered for the calculations.
Measured: Pre-infusion and 2, 6, 24, 72, 168 and 336 hours after end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was approximately 2 hours. 1 cycle=28 days
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of VAY736
PK parameters were calculated based on VAY7736 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
Measured: Pre-infusion and 2, 6, 24, 72, 168 and 336 hours after end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was approximately 2 hours. 1 cycle=28 days
Maximum Observed Plasma Concentration (Cmax) of Ibrutinib
PK parameters were calculated based on ibrutinib plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.
Measured: Pre-dose and 0.5, 2, 6 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8. 1 cycle=28 days
Time to Reach Maximum Plasma Concentration (Tmax) of Ibrutinib
PK parameters were calculated based on ibrutinib plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) concentration following a dose. Actual recorded sampling times were considered for the calculations.
Measured: Pre-dose and 0.5, 2, 6 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8. 1 cycle=28 days
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Ibrutinib
PK parameters were calculated based on ibrutinib plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.
Measured: Pre-dose and 0.5, 2, 6 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8. 1 cycle=28 days
Number of Participants With Anti-VAY736 Antibodies
VAY736 immunogenicity was evaluated in serum samples. Anti-drug antibodies (ADA) status was defined as follows:
- ADA-negative at baseline: baseline sample where assay is ADA negative
- ADA-positive at baseline: baseline sample where assay is ADA positive
- ADA-negative post-baseline: ADA-negative sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples
- Treatment-induced ADA-positive: ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample
- Treatment-boosted ADA-positive: ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample
- ADA-inconclusive post-baseline: patient who does not qualify for any of the above definitions
Measured: Baseline (before first dose) and post-baseline (assessed throughout the VAY736 treatment, up to 7.8 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start9 Apr 2018
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400176
- Sponsor's protocol ID
- CVAY736Y2102
- Other IDs
- 5R01CA177292-09
- Status last verified
- May 2025
- First submitted
- 9 Jan 2018
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.
PubMed 34398557
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy
- ClinicalTrials.gov ID
- NCT03400176
- Acronym / sponsor ID
- CVAY736Y2102
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Keywords
- Ibrutinib, VAY736, Chronic lymphocytic leukemia, CLL, Bruton's Tyrosine Kinase, BTK mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients enrolled to the study had chronic lymphocytic leukemia (CLL) and received ibrutinib. Patients had either received ibrutinib for one year without having had a complete response or patients developed a resistance mutation to ibrutinib. This study had two parts, a dose escalation part and a dose expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: VAY736, Drug: ibrutinibIncreasing doses of VAY736 in combination with a fixed dose of ibrutinib. |
| Dose expansion | Experimental | Drug: VAY736, Drug: ibrutinibEvaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of CLL per the WHO classification
- At least 18 years of age
- Lack of a complete response after receiving ibrutinib for > 1 year OR presence of known ibrutinib resistance mutation
- Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)
Key exclusion criteria (3 listed)
- Known history of HIV
- Active hepatitis B or C infection
- Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.
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 |
|---|---|---|
| VAY736Experimental | Drug | Dose Escalation, Dose expansion |
| ibrutinibAlso: ImbruvicaApproved medication | Drug | Dose Escalation, Dose expansion |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1 (Escalation Only)
Time frame: 28 days
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of treatment with the combination of VAY736 and ibrutinib and meets the criteria defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study treatment up to 30 days after the last dose of VAY736, up to approximately 8.8 months
Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For CTCAE v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. All patients were followed for a 30-day safety follow-up period subsequent to completion of VAY736 therapy. No new AEs or SAEs were collected beyond the 30-day safety follow-up or during the efficacy follow up period.
Number of Participants With Dose Reductions and Dose Interruptions of VAY736
Time frame: Up to 7.8 months
For patients who did not tolerate the protocol-specified dosing schedule of the study drugs, dose adjustments could be permitted in order to allow the patient to continue study treatment.
Number of Participants With Dose Reductions and Dose Interruptions of Ibrutinib
Time frame: Up to 8.5 months
For patients who did not tolerate the protocol-specified dosing schedule of the study drugs, dose adjustments could be permitted in order to allow the patient to continue study treatment.
Dose Intensity of VAY736
Time frame: Up to 7.8 months
Dose intensity of VAY736 was calculated as: Actual Cumulative dose (mg/kg) / (Duration of exposure in weeks/2)
Dose Intensity of Ibrutinib
Time frame: Up to 8.5 months
Dose intensity of ibrutinib was calculated as: Actual Cumulative dose (mg) / (Duration of exposure in days)
15 secondary outcomes
CR or CRi Rate at C9 for Expansion Arm A and Arm B by Investigator Per IWCLL
Time frame: Cycle 9 Day 1 (C9). The duration of each cycle was 28 days.
Posterior Mean of CR or CRi Response Rate at C9 for Expansion Arm A and Arm B (Bayesian Analysis)
Time frame: Cycle 9 Day 1 (C9). The duration of each cycle was 28 days.
Posterior Probability That the True CR or CRi Response Rate at C9 for Expansion Arm A and Arm B Falls in Pre-defined Activity Intervals (Bayesian Analysis)
Time frame: Cycle 9 Day 1 (C9). The duration of each cycle was 28 days.
Overall Response Rate (ORR) Assessed by Investigator Per IWCLL in the Dose Escalation Part
Time frame: Up to approximately 2.5 years
Overall Response Rate (ORR) Assessed by Investigator Per IWCLL in the Dose Expansion Part
Time frame: Up to approximately 2.7 years
Time to Progression (TTP) in the Dose Escalation Part
Time frame: Up to approximately 2.5 years
Time to Progression (TTP) in the Dose Expansion Part
Time frame: Up to approximately 2.7 years
Percentage of Participants With Clearance of Ibrutinib Resistance Mutation During Treatment (up to C9) for Expansion Arm B
Time frame: Up to Cycle 9 Day 1. The duration of each cycle was 28 days.
Maximum Observed Serum Concentration (Cmax) of VAY736
Time frame: Pre-infusion and 2, 6, 24, 72, 168 and 336 hours after end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was approximately 2 hours. 1 cycle=28 days
Time to Reach Maximum Serum Concentration (Tmax) of VAY736
Time frame: Pre-infusion and 2, 6, 24, 72, 168 and 336 hours after end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was approximately 2 hours. 1 cycle=28 days
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of VAY736
Time frame: Pre-infusion and 2, 6, 24, 72, 168 and 336 hours after end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of the infusion was approximately 2 hours. 1 cycle=28 days
Maximum Observed Plasma Concentration (Cmax) of Ibrutinib
Time frame: Pre-dose and 0.5, 2, 6 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8. 1 cycle=28 days
Time to Reach Maximum Plasma Concentration (Tmax) of Ibrutinib
Time frame: Pre-dose and 0.5, 2, 6 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8. 1 cycle=28 days
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Ibrutinib
Time frame: Pre-dose and 0.5, 2, 6 and 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 8. 1 cycle=28 days
Number of Participants With Anti-VAY736 Antibodies
Time frame: Baseline (before first dose) and post-baseline (assessed throughout the VAY736 treatment, up to 7.8 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34398557Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.
- A Plain Language Trial Summary is available on www.novctrd.comLink 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VAY736 and ibrutinib in people with Chronic Lymphocytic Leukemia (CLL), run by Novartis Pharmaceuticals at 5 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1 (Escalation Only) (time frame: 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400176, which also lists 1 linked publication.
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 May 2025.