Chronic Lymphocytic LeukemiaPhase 1/2NCT03534323
Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS
A Phase 1/2 study testing Duvelisib and Venetoclax in people with Chronic Lymphocytic Leukemia and Richter Syndrome, run by Dana-Farber Cancer Institute at 7 sites in United States.
Trial summary
This research study is assessing a new drug, duvelisib, in combination with a drug that is already FDA approved, venetoclax, as a possible treatment for participants with CLL or those with Richter's Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Richter Syndrome
- What is being tested?
- Duvelisib and Venetoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Jul 2018to 1 Jul 2026
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma requiring therapy, as per IW-CLL 2008 criteria OR Biopsy proven transformation to diffuse large B cell lymphoma (DLBCL), consistent with Richter's Syndrome
- Disease that has progressed during or relapsed after at least one previous CLL/SLL therapy - If Richter's Syndrome, this criterion is not applicable
- Age greater to or equal to 18 years
- ECOG performance status ≤2 (Karnofsky ≥60%)
- Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement of CLL confirmed on biopsy:
- Absolute neutrophil count ≥500 cells/mm3 (0.5 x 109/L). Growth factor is allowed in order to achieve this
Show all 13Show fewer
- Platelet count ≥25,000 cells/mm3 (25 x 109/L) independent of transfusion within 7 days of screening
- Adequate hepatic function defined as:
- --Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
- Adequate renal function as defined as:
- --Serum creatinine ≤1.5 times the upper limit of normal or creatinine clearance ≥ 50 mL/min using a 24-hour urine collection
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method or abstinence) prior to study entry and for the duration of study participation
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Previous treatment with venetoclax or duvelisib
- Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery within 2 weeks of Cycle 1/Day 1 with the following exceptions:
- For patients on targeted therapies, a washout of least five half lives is required
- Patients who experience clinical deterioration may start therapy after a shorter washout period with prior approval by the PI
- Corticosteroid therapy (prednisone or equivalent <20 mg daily) is allowed
- Confirmed central nervous system involvement
Show all 24Show fewer
- Allogeneic hematologic stem cell transplant within 6 months of starting study treatment or active graft vs. host disease (GVHD) requiring treatment or prophylaxis
- History of active malignancy requiring therapy with the exception of hormonal therapy
- Any active systemic infection requiring IV antibiotics or uncontrolled, active infections
- Known history of human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
- Major surgery within 4 weeks of first dose of study drug
- Currently active gastrointestinal disease, including colitis, inflammatory bowel disease and diarrhea requiring therapy
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
- Use of Coumadin for anticoagulation (other anticoagulants permitted)
- Lactating or pregnant
- Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A (see Appendix D) . The concomitant use of drugs or foods that are strong or moderate inhibitors or inducers of CYP3A are not allowed beginning 1 week prior to the first dose of duvelisib.
- Patients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medications
- Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction resulting in malabsorption or chronic diarrhea
- Active abuse of alcohol
- History of chronic liver disease or veno-occlusive disease/sinusoidal obstruction syndrome
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
- Known hypersensitivity to duvelisib and/or its excipients
- History of tuberculosis treatment within the 2 years prior to initiation of therapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northern Light Eastern Maine Medical Center
Brewer, Maine, 04412
University of Miami- Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Berkshire Medical Center
Pittsfield, Massachusetts, 01201
About this study
Official title: A Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma or Patients With Richter's Syndrome
This research study is assessing a new drug, duvelisib, in combination with a drug that is already FDA approved, venetoclax, as a possible treatment for participants with CLL or those with Richter's Syndrome
Read the detailed description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drugs and also tries to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied together for the first time.
This phase I study tests the safety of the drug duvelisib when used in combination with the drug venetoclax. Duvelisib is still being studied, but the FDA (the U.S. Food and Drug Administration) has approved the use of Duvelisib in patients with CLL/SLL with relapsed or refractory CLL after having received 2 or more prior therapies.
Duvelisib is a drug that is given in capsule form and taken by mouth. This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells. In laboratory studies and in other clinical trials that included participants with CLL, duvelisib was effective at killing CLL cells.
Venetoclax is a tablet that is taken by mouth. Venetoclax targets a protein called BCL-2, which helps cancer cells survive. Venetoclax is an effective treatment for many participants with CLL who do not respond to chemotherapy or other approved drugs or who have relapsed after prior therapy.Venetoclax is FDA approved for participants with CLL who have never had therapy before or whose CLL has worsened after prior therapy.
In the phase I portion of this study, the investigators are looking to determine the dose of venetoclax that is safe to give with duvelisib and to see what the side effects are of this combination.
In the phase II portion of this study, we are looking to determine how effective thecombination of duvelisib and venetoclax is for patients with CLL or Richter's Syndrome
- Conditions
- Chronic Lymphocytic Leukemia, Richter Syndrome
- Being tested
- Duvelisib, Venetoclax
- Keywords
- chronic lymphocytic leukemia (CLL), Richter's Syndrome, Richter's Transformation
- 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.
DuvelisibDrug
Also called IPI-145
This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells.
VenetoclaxDrug
Also called Venclexta
Venetoclax targets a protein called BCL-2, which helps cancer cells survive.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Level 1: 100 mg Venetoclax (daily) + 25 mg Duvelisib (BID) | Experimental | Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
* Duvelisib will be administered orally twice daily of 25mg
* Venetoclax will be administered orally daily of 100mg
* All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation Receives: Drug: Duvelisib; Drug: Venetoclax |
| Phase 1 Level 2: 200 mg Venetoclax (daily) + 25 mg Duvelisib (BID) | Experimental | * Duvelisib will be administered orally twice daily of 25mg
* Venetoclax will be administered orally daily of 200mg
* All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation Receives: Drug: Duvelisib; Drug: Venetoclax |
| Phase 1 Level 3: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID) | Experimental | * Duvelisib will be administered orally twice daily of 25mg
* Venetoclax will be administered orally daily of 400mg
* All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation Receives: Drug: Duvelisib; Drug: Venetoclax |
| Phase 2: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID) | Experimental | * Duvelisib will be administered orally twice daily of 25mg
* Venetoclax will be administered orally daily of 400mg Receives: Drug: Duvelisib; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CRR)
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) based on IWCLL 2008 and Lugano 2014 criteria for RS.
Measured: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.
Overall Response Rate (ORR)
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on IWCLL 2008 and Lugano 2014 criteria for RS.
Measured: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.
Secondary outcomes (3)
12-month Progression-Free Survival (PFS) Rate
Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last disease assessment.
Measured: Relevant to this endpoint is at 12 month.
1-year Overall Survival (OS)
1-year OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive.
Measured: Relevant to this endpoint is 1 year.
1-year MRD Negativity Rate
Defined by the proportion of participants achieved the MRD negative CR in bone marrow.
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start12 Jul 2018
- Primary completion1 Dec 2024
- Study completion1 Jul 2026
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 LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Secura Bio, Inc.
- Responsible party
- Principal investigator, Matthew S. Davids, MD, Dana-Farber Cancer Institute
- Investigators
- Matthew S Davids, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534323
- Sponsor's protocol ID
- 18-089
- Status last verified
- Oct 2026
- First submitted
- 2 May 2018
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crombie JL, Ryan CE, Ren Y, Tyekucheva S, Carey C, Zou A, Normilus S, Montegaard J, Bhandari S, Alencar A, Soumerai JD, Arnason JE, Kim AI, Parry EM, Armand P, Fisher DC, Brown JR, Davids MS. A phase 1/2 study of duvelisib plus venetoclax in patients with relapsed/refractory CLL/SLL or Richter transformation. Blood Adv. 2026 Jun 9;10(11):3811-3819. doi: 10.1182/bloodadvances.2025018878.
PubMed 41886642
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma or Patients With Richter's Syndrome
- ClinicalTrials.gov ID
- NCT03534323
- Acronym / sponsor ID
- 18-089
- Conditions
- Chronic Lymphocytic Leukemia, Richter Syndrome
- Keywords
- chronic lymphocytic leukemia (CLL), Richter's Syndrome, Richter's Transformation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Secura Bio, Inc.
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is assessing a new drug, duvelisib, in combination with a drug that is already FDA approved, venetoclax, as a possible treatment for participants with CLL or those with Richter's Syndrome
Detailed description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drugs and also tries to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied together for the first time.
This phase I study tests the safety of the drug duvelisib when used in combination with the drug venetoclax. Duvelisib is still being studied, but the FDA (the U.S. Food and Drug Administration) has approved the use of Duvelisib in patients with CLL/SLL with relapsed or refractory CLL after having received 2 or more prior therapies.
Duvelisib is a drug that is given in capsule form and taken by mouth. This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells. In laboratory studies and in other clinical trials that included participants with CLL, duvelisib was effective at killing CLL cells.
Venetoclax is a tablet that is taken by mouth. Venetoclax targets a protein called BCL-2, which helps cancer cells survive. Venetoclax is an effective treatment for many participants with CLL who do not respond to chemotherapy or other approved drugs or who have relapsed after prior therapy.Venetoclax is FDA approved for participants with CLL who have never had therapy before or whose CLL has worsened after prior therapy.
In the phase I portion of this study, the investigators are looking to determine the dose of venetoclax that is safe to give with duvelisib and to see what the side effects are of this combination.
In the phase II portion of this study, we are looking to determine how effective thecombination of duvelisib and venetoclax is for patients with CLL or Richter's Syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Level 1: 100 mg Venetoclax (daily) + 25 mg Duvelisib (BID) | Experimental | Drug: Duvelisib, Drug: VenetoclaxDuvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added. * Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 100mg * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation |
| Phase 1 Level 2: 200 mg Venetoclax (daily) + 25 mg Duvelisib (BID) | Experimental | Drug: Duvelisib, Drug: Venetoclax* Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 200mg * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation |
| Phase 1 Level 3: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID) | Experimental | Drug: Duvelisib, Drug: Venetoclax* Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 400mg * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation |
| Phase 2: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID) | Experimental | Drug: Duvelisib, Drug: Venetoclax* Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 400mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma requiring therapy, as per IW-CLL 2008 criteria OR Biopsy proven transformation to diffuse large B cell lymphoma (DLBCL), consistent with Richter's Syndrome
- Disease that has progressed during or relapsed after at least one previous CLL/SLL therapy - If Richter's Syndrome, this criterion is not applicable
- Age greater to or equal to 18 years
- ECOG performance status ≤2 (Karnofsky ≥60%)
- Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement of CLL confirmed on biopsy:
Key exclusion criteria (24 listed)
- Previous treatment with venetoclax or duvelisib
- Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery within 2 weeks of Cycle 1/Day 1 with the following exceptions:
- Confirmed central nervous system involvement
- Allogeneic hematologic stem cell transplant within 6 months of starting study treatment or active graft vs. host disease (GVHD) requiring treatment or prophylaxis
- History of active malignancy requiring therapy with the exception of hormonal therapy
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 |
|---|---|---|
| DuvelisibAlso: IPI-145This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells. | Drug | Phase 1 Level 1: 100 mg Venetoclax (daily) + 25 mg Duvelisib (BID), Phase 1 Level 2: 200 mg Venetoclax (daily) + 25 mg Duvelisib (BID), Phase 1 Level 3: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID), Phase 2: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID) |
| VenetoclaxAlso: VenclextaVenetoclax targets a protein called BCL-2, which helps cancer cells survive. | Drug | Phase 1 Level 1: 100 mg Venetoclax (daily) + 25 mg Duvelisib (BID), Phase 1 Level 2: 200 mg Venetoclax (daily) + 25 mg Duvelisib (BID), Phase 1 Level 3: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID), Phase 2: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID) |
Primary outcome
Complete Response Rate (CRR)
Time frame: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) based on IWCLL 2008 and Lugano 2014 criteria for RS.
Overall Response Rate (ORR)
Time frame: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on IWCLL 2008 and Lugano 2014 criteria for RS.
3 secondary outcomes
12-month Progression-Free Survival (PFS) Rate
Time frame: Relevant to this endpoint is at 12 month.
1-year Overall Survival (OS)
Time frame: Relevant to this endpoint is 1 year.
1-year MRD Negativity Rate
Time frame: At 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41886642Crombie JL, Ryan CE, Ren Y, Tyekucheva S, Carey C, Zou A, Normilus S, Montegaard J, Bhandari S, Alencar A, Soumerai JD, Arnason JE, Kim AI, Parry EM, Armand P, Fisher DC, Brown JR, Davids MS. A phase 1/2 study of duvelisib plus venetoclax in patients with relapsed/refractory CLL/SLL or Richter transformation. Blood Adv. 2026 Jun 9;10(11):3811-3819. doi: 10.1182/bloodadvances.2025018878.
- 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.
Matthew S Davids, MD principal investigator
Dana-Farber Cancer Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Duvelisib and Venetoclax in people with Chronic Lymphocytic Leukemia and Richter Syndrome, run by Dana-Farber Cancer Institute at 7 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 13 inclusion and 24 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 23 Mar 2026). 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?
Complete Response Rate (CRR) (time frame: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.). The study lists 2 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 NCT03534323, 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 28 Oct 2026.