CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL
This study is testing a new combination of treatments for adults with leukemia (ALL/LBL) or lymphoblastic lymphoma that has come back or not responded to previous treatments. It combines capivasertib, venetoclax, and a low-intensity chemotherapy called mini-hyperCVD. Some participants may also receive rituximab, blinatumomab, or nelarabine. The first part of the study will find the safest dose of capivasertib to use with the other drugs. Later parts will look at how well this combination works. The study aims to enroll 104 participants aged 18 and older who have at least 5% leukemia cells in their bone marrow or blood, or measurable disease outside the bone marrow.
- Study design
- This is a three-part interventional study with an estimated 104 participants. The first part focuses on finding a safe dose of capivasertib when combined with other treatments.
- What's involved
- Participants will take capivasertib and venetoclax by mouth. Some may receive rituximab, blinatumomab, or nelarabine through an IV. Treatment cycles are approximately every 28 days, with some treatments given on a 4-days-on, 3-days-off schedule.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess efficacy after all participants have completed treatment, which is expected to be an average of about 8 months.
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NCT07294677
CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of ChicagoInvestigator-initiated
~104 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:CapivasertibVenetoclaxRituximabBlinatumomabNelarabinemini-hyperCVD
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of the combination of mini-hyperCVD and venetoclax plus capivasertib [Cohort 1]
Measured over After all cohort 1 participants have completed 2 28-day cycles of study treatment
+2 more outcomes measured
Conditions
NCT07294677
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinoisstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Caner Saygin · STUDY_CHAIR · University of Chicago
Who to contact
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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients with acute leukemia with lymphoid lineage (B-ALL, T-ALL, ETP-ALL, mixed phenotype or bi-phenotypic) or lymphoblastic lymphoma (B- or T-lineage) that is relapsed or refractory
Bone marrow or peripheral blood involvement with ≥5% leukemic blasts. Patients with isolated extramedullary disease that is measurable by CT scan are also eligible.
18 years or older
ECOG performance status 0-2
Adequate organ function meeting protocol criteria
Patients must be at least 2 weeks from major surgery or radiation therapy. A wash-out period of 5 half-lives is required for patients who participated in other investigational trials. These patients must have recovered from clinically significant toxicities related to these prior treatments.
Patients must voluntarily sign and date an informed consent prior to the initiation of any screening or study-specific procedures.
Females of childbearing potential will use effective contraception during protocol treatment and for at least 8 months after the last dose. Males with female partners of reproductive potential will use effective contraception during protocol treatment and for at least 5 months after the last dose.
Relapsed or refractory patients with acute leukemia with lymphoid lineage (B-ALL, T-ALL, ETP-ALL, mixed phenotype or bi-phenotypic) or lymphoblastic lymphoma (B- or T-lineage)
Bone marrow or peripheral blood involvement with ≥5% leukemic blasts. Patients with isolated extramedullary disease that is measurable by CT scan are also eligible.
18 years or older
ECOG performance status 0-2
Adequate organ function meeting protocol criteria
Patients must be at least 2 weeks from major surgery or radiation therapy. A wash-out period of 5 half-lives is required for patients who participated in other investigational trials. These patients must have recovered from clinically significant toxicities related to these prior treatments.
Patients must voluntarily sign and date an informed consent prior to the initiation of any screening or study-specific procedures.
Females of childbearing potential will use effective contraception during protocol treatment and for at least 8 months after the last dose. Males with female partners of reproductive potential will use effective contraception during protocol treatment and for at least 5 months after the last dose.
Previously untreated patients with acute leukemia with lymphoid lineage (B-ALL, T-ALL, ETP-ALL, mixed phenotype or bi-phenotypic) or lymphoblastic lymphoma (B- or T-lineage)
Bone marrow or peripheral blood involvement with ≥20% leukemic blasts. Patients with isolated extramedullary disease that is measurable by CT scan are also eligible.
Previous therapy with dexamethasone or hydroxyurea given for cytoreductive purposes is allowed.
40 years old or older
ECOG performance status 0-2
Adequate organ function per protocol criteria
Patients must be at least 2 weeks from major surgery.
Patients must voluntarily sign and date an informed consent prior to the initiation of any screening or study-specific procedures.
Females of childbearing potential will use effective contraception during protocol treatment and for at least 8 months after the last dose. Males with female partners of reproductive potential will use effective contraception during protocol treatment and for at least 5 months after the last dose.
Exclusion
Ph-positive ALL, Burkitt's leukemia/lymphoma
Patient is pregnant or breastfeeding
Patients with uncontrolled infection.
Known active hepatitis B or C infection, or uncontrolled human immunodeficiency virus (HIV) infection. Patients with HIV infection, whose disease is controlled with anti-retroviral therapy are eligible, but their highly active antiretroviral therapy (HAART) should be modified to minimize drug interactions. Due to the increased risk of hepatitis B reactivation, all patients with active, previously treated or resolved hepatitis B infection will not be eligible for rituximab treatment if their leukemia expresses \>1% CD20.
Major surgery or radiation therapy within 2 weeks prior to the first study dose
Symptomatic central nervous system (CNS) disease or spinal cord compression
Concurrent active malignancy requiring treatment with potential to influence the endpoint of the clinical trial. Patients with non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, past history of malignancy that has been definitively treated, and patients treated with hormonal therapies for solid tumors are eligible. Patients with history of multiple myeloma that does not need active treatment are also eligible.
Uncontrolled cardiac disease
Uncontrolled diabetes mellitus, defined as fasting blood glucose \>160 mg/dL or random blood glucose \>250 mg/dL. Patients with type 1 diabetes mellitus or insulin-dependent diabetes are also excluded. A1c measurements are less reliable in leukemia patients due to anemia and/or need for red cell transfusions. Patients with well-controlled, non-insulin-dependent diabetes are eligible, but their blood glucose must be monitored closely during the study period in consultation with Diabetes specialists.
Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the treating physician, would make the patient inappropriate for entry into this study.
Patients who cannot discontinue strong CYP3A inducers, grapefruit, grapefruit products, Seville oranges, or star fruit within the 3 days prior to starting venetoclax.
Ph-positive ALL, Burkitt's leukemia/lymphoma
Patient is pregnant or breastfeeding
Patients with uncontrolled infection. Patients with infections that have been controlled for ≥7 days will be eligible.
Known active hepatitis B or C infection, or uncontrolled human immunodeficiency virus (HIV) infection. Patients with HIV infection, whose disease is controlled with anti-retroviral therapy are eligible, but their highly active antiretroviral therapy (HAART) should be modified to minimize drug interactions. Due to the increased risk of hepatitis B reactivation, all patients with active, previously treated or resolved hepatitis B infection will not be eligible for rituximab treatment if their leukemia expresses \>1% CD20.
Major surgery or radiation therapy within 2 weeks prior to the first study dose
Symptomatic central nervous system (CNS) disease or spinal cord compression
Concurrent active malignancy requiring treatment with potential to influence the endpoint of the clinical trial. Patients with non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, past history of malignancy that has been definitively treated, and patients treated with hormonal therapies for solid tumors are eligible. Patients with history of multiple myeloma that does not need active treatment are also eligible.
Uncontrolled cardiac disease
Uncontrolled diabetes mellitus, defined as fasting blood glucose \>160 mg/dL or random blood glucose \>250 mg/dL. Patients with type 1 diabetes mellitus or insulin-dependent diabetes are also excluded. A1c measurements are less reliable in leukemia patients due to anemia and/or need for red cell transfusions. Patients with well-controlled, non-insulin-dependent diabetes are eligible, but their blood glucose must be monitored closely during the study period in consultation with Diabetes specialists.
Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the treating physician, would make the patient inappropriate for entry into this study.
Patients who cannot discontinue strong CYP3A inducers, grapefruit, grapefruit products, Seville oranges, or star fruit within the 3 days prior to starting venetoclax.
Ph-positive ALL, Burkitt's leukemia/lymphoma
Patient is pregnant or breastfeeding
Patients with uncontrolled infection. Patients with infections that have been controlled for ≥7 days will be eligible.
Known active hepatitis B or C infection, or uncontrolled human immunodeficiency virus (HIV) infection. Patients with HIV infection, whose disease is controlled with anti-retroviral therapy are eligible, but their highly active antiretroviral therapy (HAART) should be modified to minimize drug interactions. Due to the increased risk of hepatitis B reactivation, all patients with active, previously treated or resolved hepatitis B infection will not be eligible for rituximab treatment if their leukemia expresses \>1% CD20.
Major surgery or radiation therapy within 2 weeks prior to the first study dose
Symptomatic central nervous system (CNS) disease or spinal cord compression
Concurrent active malignancy requiring treatment with potential to influence the endpoint of the clinical trial. Patients with non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, past history of malignancy that has been definitively treated, and patients treated with hormonal therapies for solid tumors are eligible. Patients with history of multiple myeloma that does not need active treatment are also eligible.
Uncontrolled cardiac disease
Uncontrolled diabetes mellitus, defined as fasting blood glucose \>160 mg/dL or random blood glucose \>250 mg/dL. Patients with type 1 diabetes mellitus or insulin-dependent diabetes are also excluded. A1c measurements are less reliable in leukemia patients due to anemia and/or need for red cell transfusions. Patients with well-controlled, non-insulin-dependent diabetes are eligible, but their blood glucose must be monitored closely during the study period in consultation with Diabetes specialists.
Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the treating physician, would make the patient inappropriate for entry into this study.
Any prior systemic chemotherapy or radiotherapy for treatment of ALL/LBL is an exclusion with the exception of hydroxyurea, steroids, ATRA and/or intrathecal chemotherapy. No more than 2 weeks of steroids is permitted.
Patients who cannot discontinue strong CYP3A inducers, grapefruit, grapefruit products, Seville oranges, or star fruit within the 3 days prior to starting venetoclax.
What this trial measures
- Safety of the combination of mini-hyperCVD and venetoclax plus capivasertib [Cohort 1]After all cohort 1 participants have completed 2 28-day cycles of study treatment
Summary of dose limiting toxicities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.
- Recommended Phase 2 Dose (RP2D) of capivasertib in combination with mini-hyperCVD and venetoclax [Cohort 1]This will be assessed after all cohort 1 participants have completed 2 28-day cycles of study treatment
The dose that dose not cause dose limiting toxicities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5 will be identified as the RP2D.
- Efficacy of capivasertib in combination with mini-hyperCVD and venetoclax [Cohort 2 and 3]This will be assessed after all participants have completed treatment (an average of about 8 months)
Number of participants with complete remission (CR) with measurable residual disease (MRD) negativity