Leukemia, MyeloidPhase 1GAVELNCT07439211
Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia
A Phase 1 study testing Eganelisib, Azacitidine and Venetoclax in people with Leukemia, Myeloid and Leukemia, run by Jacqueline Garcia, MD at 2 sites in United States.
Trial summary
This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Leukemia, Myeloid, Leukemia, Acute Myeloid Leukemia
- What is being tested?
- Eganelisib, Azacitidine 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
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Apr 2026to 1 Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically confirmed AML that meets one of these categories of disease:
- Group A: Relapsed or Refractory: Subjects with relapsed or refractory AML or relapsed/refractory AML, who are not recommended for any approved targeted therapy must meet any one of the following criteria: (1) morphologic relapse (at least 5% blasts), or (2) refractory to intensive chemotherapy (at least one cycle of cytarabine and anthracycline-based intensive regimen) or at least 2 cycles of prior HMA/venetoclax-based therapy (without CR/CRh/CRi). No limit to prior lines of AML therapy. OR
- (Expansion only) Group B: Untreated AML with ELN 2022 adverse risk disease: Subjects with newly diagnosed or previously untreated AML must be ineligible for intensive chemotherapy based on Ferrara criteria (age ≥75 years or presence of co- morbidity).
- Evidence of marrow involved AML.
- Age 18-90 years. Because no dosing or adverse event data are currently available on the use of eganelisib in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- Eastern Cooperative Oncology Group performance status ≤ 3 if 18 to 74 years of age or ECOG 0-2 if ≥ 75 years of age.
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- Subjects must meet the following organ and marrow function as defined below:
- total serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or
- ≤ 3 x ULN in case of Gilbert's disease
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x × institutional ULN
- Creatinine clearance (CrCl) ≥ 30 L/min (Cockcroft-Gault formula)
- Prior history of CNS leukemia that has been treated, asymptomatic and controlled are eligible. CNS evaluation is not required for screening if asymptomatic.
- Subjects with a prior or concurrent malignancy (other than MDS, MPN, MDS/MPN, or AML) whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Treatment must be at least 12 months from last dose of chemotherapy or immunotherapy (except no window is required for palliative radiation or supportive or hormonal therapies). Concurrent malignancy must be considered not active or requiring therapy.
- Male subjects and female subjects/women of childbearing potential (WCBP) must agree to the following: The effects of eganelisib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. When eganelisib is being used alone, the duration of contraception after the last dose should be 3 months for both males and females of childbearing potential. When eganelisib is being used with azacitidine + venetoclax, according to the USPI for azacitidine, females of reproductive potential should use effective contraception during treatment with azacitidine and for 6 months after the last dose and males with female partners of reproductive potential should use effective contraception during treatment with azacitidine and for 3 months after the last dose. WCBP must have negative serum beta human chorionic gonadotropin test measured within 7 days prior to the first dose of eganelisib and consent to ongoing pregnancy testing during the study.
- Willingness to practice adequate sun protection (i.e. use of sunscreen or sun-protective clothing, limitation of sun and artificial ultraviolet [UV] exposure) for the study duration and for 30 days after the last dose of eganelisib.
- Agree to the protocol-required bone marrow biopsies.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior systemic cancer therapy is allowed as long as >14 days prior to study treatment start. Hormonal therapy may be allowed if approved by Sponsor-Investigator.
- Major surgery within 28 days prior to study treatment start.
- Allogeneic stem cell transplant within 100 days prior to study treatment start.
- Active graft-versus-host disease (GVHD) after allogeneic stem cell transplantation or chronic GVHD requiring systemic steroid administration. Topical therapies are allowed for controlled GVHD.
- Receiving systemic immunosuppressive therapy such as steroids or calcineurin inhibitors.
- Participants who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia.
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- Participants who are receiving any other investigational AML directed-agents for this condition.
- White blood cell count > 25x109/L prior to first dose of study treatment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to eganelisib, venetoclax, or azacitidine.
- Participants receiving any medications or substances within 14 days prior to first dose of study drug and for duration of the study:
- Moderate or strong inhibitors or inducers of CYP2C8 and CYP3A4, including grapefruit, grapefruit juice, Seville oranges, St. John's wort and herbal supplements, except for antibiotics, antifungals, or antivirals that are moderate or strong inhibitors of CYP3A (preference for moderate CYP3A inhibitors if antifungal therapy is recommended when clinically acceptable).
- P-glycoprotein (P-gp) inhibitors except for azole antifungals.
- Breast cancer resistance protein (BCRP) inhibitors.
- Administration of any of the following as of Cycle 1 Day 1 and for the study duration: Substrates with a narrow therapeutic index for P-gp, or Warfarin, phenytoin, or other substrates with a narrow therapeutic index for CYP2C8 or CYP2C9
- Pregnant women are excluded from this study because eganelisib is an agent without known fertility and developmental toxicity studies. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with eganelisib, breastfeeding should be discontinued if the mother is treated with eganelisib. These potential risks may also apply to other agents used in this study.
- History or current evidence of any acute or chronic condition, therapy, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or might confound the results of the trial, interfere with participation for the full duration of the trial, or render trial participation not compatible with the participant's best interest, in the opinion of the Investigator.
- Participant must be able to swallow pills and not have any known gastrointestinal abnormality that would affect drug absorption (examples include gastric bypass, gastrectomy, chronic diarrhea).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jacqueline S Garcia, MD, 617-632-6577, jacqueline_garcia@dfci.harvard.edu
Jacqueline Garcia, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Jacqueline S Garcia, MD, 617-632-6577, Jacqueline_garcia@dfci.harvard.edu
Jacqueline Garcia, MD
About this study
Official title: Safety of Targeting PI3Kgamma Signaling With Azacitidine, Venetoclax and Eganelisib in Acute Myeloid Leukemia: A Phase 1 Study (GAVEL)
This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML).
The names of the study drugs involved in this research study are:
- Venetoclax (a type of BCL-2 inhibitor)
- Azacitidine (a type of Demethylating Agent)
- Eganelisib (a type of PI3K-gamma inhibitor)
Read the detailed description
This phase 1 clinical trial is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML).
The dose-escalation portion of the trial will aim to establish the maximum tolerated dose of the drug, eganelisib, for the recommended phase 2 dose. The dose-expansion portion of the trial will aim to confirm the recommended phase 2 dose of the drug, eganelisib.
The U.S. Food and Drug Administration (FDA) has not approved eganelisib as a treatment for acute myeloid leukemia.
The FDA has approved azacitidine and venetoclax as a treatment option for AML. However, the combination of these two drugs with eganelisib (three drug or triplet regimen) has not been FDA approved.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, electrocardiograms (ECGs), and bone marrow biopsies and aspirations.
It is expected that up to 48 people will take part in this research study. Stelexis BioSciences, Inc. is supporting this study by providing funding and the study drug, eganelisib.
- Being tested
- Eganelisib, Azacitidine, Venetoclax
- Keywords
- Leukemia, Myeloid, Leukemia, Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, AML
- Medical subject headings
- Leukemia, Myeloid, Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EganelisibDrug
Also called IPI-549
PI3K-gamma inhibitor, capsule taken orally per protocol.
AzacitidineDrug
Demethylating Agent, single use vial, via subcutaneous (under the skin) injection or intravenous (into the vein) infusion per standard of care.
VenetoclaxDrug
Also called C45H50ClN7O7S
BCL-2 inhibitor, tablet taken orally per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Dose-Escalation Eganelisib | Experimental | Dose-Escalation with triplet azacitidine D1-7, venetoclax D1-28 and eganelisib D1-28 (dose-escalated)
* Baseline visit
* Treatment in 28 day cycles
* End of treatment visit
* Follow up every 4 months for up to 1 year after end of treatment (for survival). Receives: Drug: Eganelisib; Drug: Azacitidine; Drug: Venetoclax |
| Dose-Expansion Eganelisib | Experimental | Dose-Escalation with triplet azacitidine D1-7, venetoclax D1-28 and eganelisib D1-28 (dose-expansion at MTD/RP2D)
* Baseline visit
* Treatment in 28 day cycles
* End of treatment visit
* Follow up every 4 months for up to 1 year after end of treatment (for survival). Receives: Drug: Eganelisib; Drug: Azacitidine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eganelisib Recommended Phase 2 Dose (RP2D)
The eganelisib (daily) RP2D in combination with azacitidine 75 mg/m^2/day on days 1-7 and venetoclax 400 mg daily (28 days) is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The RP2D is based on the Bayesian optimal interval design (BOIN). The RP2D may also be based on available pharmacokinetic (PK) and pharmacodynamic (PD) data.
Measured: 1 cycle=28 days
Recommended Phase 2 Dose (RP2D)
Number of Participants experiencing protocol-defined DLT
Measured: 1 cycle=28 days
Secondary outcomes (9)
Treatment-Related Grade 3-4 Adverse Event (AE) Rate
Percentage of participants who experience an AE of grade 3 or 4 with treatment attribution of possible, probable or definite per Common Toxicity Adverse Event Criteria (CTCAE) version 5.
Measured: through study completion, an average of 2 years
Eganelisib Feasibility Rate
Percentage of participants completing >/= 75% of planned doses of eganelisib.
Measured: First 28 days
Eganelisib Area Under the Plasma Concentration versus Time Curve (AUC)
Eganelisib AUC exposure is quantified by the integral of the plasma drug concentration-time curve over a specified time interval associated with pharmacokinetic sampling.
Measured: Up to 4 months
Complete Remission (CR) Rate
Percentage of participants achieving CR on treatment per established criteria for adult acute myeloid leukemia: European Leukemia Network (ELN) 2022
Measured: Up to 4 months
CR with Partial Hematologic Recovery (CRh) Rate
Percentage of participants achieving CRh on treatment per established criteria for adult acute myeloid leukemia: European Leukemia Network (ELN) 2022
Measured: Up to 4 months
CR with incomplete count recovery (CRi) with Minimal Residual Disease (MRD) Negative Rate
Percentage of participants achieving CRi on treatment per established criteria for adult acute myeloid leukemia: European Leukemia Network (ELN) 2022 as well as MRD negativity per ELN 2021 criteria
Measured: Up to 4 months
Partial Remission (PR) Rate
Percentage of participants achieving PR on treatment per established criteria for adult acute myeloid leukemia: European Leukemia Network (ELN) 2022
Measured: Up to 4 months
Duration of Remission (DOR)
DOR estimated with the Kaplan-Meier method is defined as the time from CR until disease relapse per established criteria for adult acute myeloid leukemia: European Leukemia Network (ELN) 2022. Participants not experiencing disease relapse are censored at the date disease-free or end of follow-up.
Measured: through study completion, an average of 2 years
Subsequent Allogeneic Stem-Cell Transplant Rate
The proportion of participants who initiate allogeneic stem cell transplant as next line of therapy.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start13 Apr 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, MyeloidStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- dose-escalation followed by expansion
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacqueline Garcia, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Stelexis BioSciences, Inc.
- Responsible party
- Sponsor-investigator, Jacqueline Garcia, MD, Dana-Farber Cancer Institute
- Investigators
- Jacqueline Garcia, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439211
- Sponsor's protocol ID
- DFCI 25-820
- Acronym
- GAVEL
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Targeting PI3Kgamma Signaling With Azacitidine, Venetoclax and Eganelisib in Acute Myeloid Leukemia: A Phase 1 Study (GAVEL)
- ClinicalTrials.gov ID
- NCT07439211
- Acronym / sponsor ID
- GAVEL / DFCI 25-820
- Keywords
- Leukemia, Myeloid, Leukemia, Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jacqueline Garcia, MDUniversity, hospital or other
- Collaborators
- Stelexis BioSciences, Inc.
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 27 Feb 2026 (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.
This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML).
The names of the study drugs involved in this research study are:
- Venetoclax (a type of BCL-2 inhibitor)
- Azacitidine (a type of Demethylating Agent)
- Eganelisib (a type of PI3K-gamma inhibitor)
Detailed description
This phase 1 clinical trial is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML).
The dose-escalation portion of the trial will aim to establish the maximum tolerated dose of the drug, eganelisib, for the recommended phase 2 dose. The dose-expansion portion of the trial will aim to confirm the recommended phase 2 dose of the drug, eganelisib.
The U.S. Food and Drug Administration (FDA) has not approved eganelisib as a treatment for acute myeloid leukemia.
The FDA has approved azacitidine and venetoclax as a treatment option for AML. However, the combination of these two drugs with eganelisib (three drug or triplet regimen) has not been FDA approved.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, electrocardiograms (ECGs), and bone marrow biopsies and aspirations.
It is expected that up to 48 people will take part in this research study. Stelexis BioSciences, Inc. is supporting this study by providing funding and the study drug, eganelisib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- dose-escalation followed by expansion
| Arm | Type | Receives |
|---|---|---|
| Dose-Escalation Eganelisib | Experimental | Drug: Eganelisib, Drug: Azacitidine, Drug: VenetoclaxDose-Escalation with triplet azacitidine D1-7, venetoclax D1-28 and eganelisib D1-28 (dose-escalated) * Baseline visit * Treatment in 28 day cycles * End of treatment visit * Follow up every 4 months for up to 1 year after end of treatment (for survival). |
| Dose-Expansion Eganelisib | Experimental | Drug: Eganelisib, Drug: Azacitidine, Drug: VenetoclaxDose-Escalation with triplet azacitidine D1-7, venetoclax D1-28 and eganelisib D1-28 (dose-expansion at MTD/RP2D) * Baseline visit * Treatment in 28 day cycles * End of treatment visit * Follow up every 4 months for up to 1 year after end of treatment (for survival). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects must have histologically confirmed AML that meets one of these categories of disease:
- Evidence of marrow involved AML.
- Age 18-90 years. Because no dosing or adverse event data are currently available on the use of eganelisib in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- Eastern Cooperative Oncology Group performance status ≤ 3 if 18 to 74 years of age or ECOG 0-2 if ≥ 75 years of age.
- Subjects must meet the following organ and marrow function as defined below:
Key exclusion criteria (17 listed)
- Prior systemic cancer therapy is allowed as long as >14 days prior to study treatment start. Hormonal therapy may be allowed if approved by Sponsor-Investigator.
- Major surgery within 28 days prior to study treatment start.
- Allogeneic stem cell transplant within 100 days prior to study treatment start.
- Active graft-versus-host disease (GVHD) after allogeneic stem cell transplantation or chronic GVHD requiring systemic steroid administration. Topical therapies are allowed for controlled GVHD.
- Receiving systemic immunosuppressive therapy such as steroids or calcineurin inhibitors.
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 |
|---|---|---|
| EganelisibAlso: IPI-549PI3K-gamma inhibitor, capsule taken orally per protocol. | Drug | Dose-Escalation Eganelisib, Dose-Expansion Eganelisib |
| AzacitidineDemethylating Agent, single use vial, via subcutaneous (under the skin) injection or intravenous (into the vein) infusion per standard of care. | Drug | Dose-Escalation Eganelisib, Dose-Expansion Eganelisib |
| VenetoclaxAlso: C45H50ClN7O7SBCL-2 inhibitor, tablet taken orally per standard of care. | Drug | Dose-Escalation Eganelisib, Dose-Expansion Eganelisib |
Primary outcome
Eganelisib Recommended Phase 2 Dose (RP2D)
Time frame: 1 cycle=28 days
The eganelisib (daily) RP2D in combination with azacitidine 75 mg/m^2/day on days 1-7 and venetoclax 400 mg daily (28 days) is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The RP2D is based on the Bayesian optimal interval design (BOIN). The RP2D may also be based on available pharmacokinetic (PK) and pharmacodynamic (PD) data.
Recommended Phase 2 Dose (RP2D)
Time frame: 1 cycle=28 days
Number of Participants experiencing protocol-defined DLT
9 secondary outcomes
Treatment-Related Grade 3-4 Adverse Event (AE) Rate
Time frame: through study completion, an average of 2 years
Eganelisib Feasibility Rate
Time frame: First 28 days
Eganelisib Area Under the Plasma Concentration versus Time Curve (AUC)
Time frame: Up to 4 months
Complete Remission (CR) Rate
Time frame: Up to 4 months
CR with Partial Hematologic Recovery (CRh) Rate
Time frame: Up to 4 months
CR with incomplete count recovery (CRi) with Minimal Residual Disease (MRD) Negative Rate
Time frame: Up to 4 months
Partial Remission (PR) Rate
Time frame: Up to 4 months
Duration of Remission (DOR)
Time frame: through study completion, an average of 2 years
Subsequent Allogeneic Stem-Cell Transplant Rate
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Jacqueline Garcia, MD principal investigator
Dana-Farber Cancer Institute
2 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 Eganelisib, Azacitidine and Venetoclax in people with Leukemia, Myeloid and Leukemia, run by Jacqueline Garcia, MD at 2 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 17 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaqueline Garcia, MD (617-632-6577, jacqueline_garcia@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eganelisib Recommended Phase 2 Dose (RP2D) (time frame: 1 cycle=28 days). 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?
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 26 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.