LeukemiaPhase 1/2CAVALRYNCT07294677
CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL
A Phase 1/2 study testing Capivasertib, Venetoclax and Rituximab in people with Leukemia and Lymphoma, run by University of Chicago at 1 site in United States.
Trial summary
This is a 3-part study to assess the safety of adding capivasertib to a standard of care treatment regimen consisting of venetoclax and low-intensity chemotherapy. This chemotherapy regimen called mini-hyperCVD consists of the chemotherapy drugs, cyclophosphamide, vincristine, dexamethasone; (part A) alternating with… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Capivasertib, Venetoclax and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2026to Mar 2032
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
- COHORT 2 Inclusion criteria
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Caner Saygin
About this study
This is a 3-part study to assess the safety of adding capivasertib to a standard of care treatment regimen consisting of venetoclax and low-intensity chemotherapy. This chemotherapy regimen called mini-hyperCVD consists of the chemotherapy drugs, cyclophosphamide, vincristine, dexamethasone; (part A) alternating with high-dose methotrexate and cytarabine (part B) administered approximately every 28 days.
In the first part of the study (Cohort 1), the study seeks to determine the recommended dose of capivasertib that can be safely given with venetoclax and chemotherapy. Several doses of capivasertib may be tested in small groups of subjects in this part of the study. The dose tested will be increased or lowered depending on types and frequency of side effects seen until the best, safe dose is found.
Read more
Once the recommended, safe dose of capivasertib is found, the study will move on to the second part (Cohort 2) and will treat additional participants to learn more about the safety of giving these drugs together.
If the combination is determined to be safe overall, the study will move on to the third part (Cohort 3). In this part of the study, participants will be randomized to receive the mini-hyperCVD and venetoclax alone or with capivasertib.
- Being tested
- Capivasertib, Venetoclax, Rituximab, Blinatumomab, Nelarabine
- Keywords
- Chemotherapy
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapivasertibDrug
Also called TRUQAP
Capivasertib taken by mouth, twice daily. Dosing will occur on a 4 days on, 3 day off schedule.
VenetoclaxDrug
Also called VENCLEXTA
Venetoclax will be taken by mouth, once daily.
RituximabDrug
Also called RITUXAN
Some participants will receive rituximab by IV infusion, two doses per cycle during the first four cycles. Whether or not this will be given to participants with leukemia cells that express a protein called CD20.
BlinatumomabDrug
Also called BLINCYTO
Some participants will receive cycles of blinatumomab by IV continuous infusion after the initial venetoclax plus chemotherapy phase for a 42-day cycle. Each cycle includes 28 days of blinatumomab dosing followed by a 14-day rest period. This will be given to participants that have a certain type of leukemia call CD19+ B-lineage ALL and who experience a complete remission.
NelarabineDrug
Also called ARRANON
Some participants in Cohorts 1 and 2 will receive nelarabine after cycles 2 and 4 at the discretion of their treating physician.
mini-hyperCVDDrug
Participants will receive 8 cycles of chemotherapy consisting of the following drugs.
They will receive the part A regimen and part B regimen in alternating cycles.
Part A: cyclophosphamide, vincristine, dexamethasone
Part B: high dose methotrexate and cytarabine.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Dose Escalation (Dose Level 1) | Experimental | In this arm, a dose of 320 mg dose of capivasertib will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen. Receives: Drug: Capivasertib; Drug: Venetoclax; Drug: Rituximab; Drug: Blinatumomab; Drug: Nelarabine; Drug: mini-hyperCVD |
| Cohort 1 - Dose Escalation (Dose Level 2) | Experimental | In this arm, a dose of 400 mg dose of capivasertib will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen. Receives: Drug: Capivasertib; Drug: Venetoclax; Drug: Rituximab; Drug: Blinatumomab; Drug: Nelarabine; Drug: mini-hyperCVD |
| Cohort 1 - Dose Escalation (Dose Level -1) | Experimental | In this arm, a dose of 200 mg dose of capivasertib will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen. Receives: Drug: Capivasertib; Drug: Venetoclax; Drug: Rituximab; Drug: Blinatumomab; Drug: Nelarabine; Drug: mini-hyperCVD |
| Cohort 2 (Expansion) | Experimental | In this arm, the best, safe dose of capivasertib found after completion of enrollment to dose escalation (cohort 1) arms, will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen. Receives: Drug: Capivasertib; Drug: Venetoclax; Drug: Rituximab; Drug: Blinatumomab; Drug: Nelarabine; Drug: mini-hyperCVD |
| Cohort 3 -- Arm 1 -- mini-hyperCVD + venetoclax (Randomized) | Active comparator | Participants randomized to this arm will receive mini-hyperCVD + venetoclax. Receives: Drug: Venetoclax; Drug: Rituximab; Drug: Blinatumomab; Drug: Nelarabine; Drug: mini-hyperCVD |
| Cohort 3 -- Arm 2 -- mini-hyperCVD + venetoclax + capivasertib (Randomized) | Experimental | Participants randomized to this arm will receive mini-hyperCVD + venetoclax and capivasertib. Receives: Drug: Capivasertib; Drug: Venetoclax; Drug: Rituximab; Drug: Blinatumomab; Drug: Nelarabine; Drug: mini-hyperCVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the combination of mini-hyperCVD and venetoclax plus capivasertib [Cohort 1]
Summary of dose limiting toxicities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: After all cohort 1 participants have completed 2 28-day cycles of study treatment
Recommended Phase 2 Dose (RP2D) of capivasertib in combination with mini-hyperCVD and venetoclax [Cohort 1]
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.
Measured: This will be assessed after all cohort 1 participants have completed 2 28-day cycles of study treatment
Efficacy of capivasertib in combination with mini-hyperCVD and venetoclax [Cohort 2 and 3]
Number of participants with complete remission (CR) with measurable residual disease (MRD) negativity
Measured: This will be assessed after all participants have completed treatment (an average of about 8 months)
Secondary outcomes (6)
Rate of clinical remission (CR) [Cohort 1]
Measured: This will be assessed after all participants have completed treatment (an average of about 8 months)
Rate of clinical remission with incomplete count recovering (CRi) [Cohort 1]
Measured: This will be assessed after all participants have completed treatment (an average of about 8 months)
Rate of CR with measurable residual disease (MRD) negativity [Cohort 1]
Measured: This will be assessed after all participants have completed treatment (an average of about 8 months)
Progression free survival [All Cohorts]
Measured: up to 10 years after treatment completion
Overall survival [Cohort 2 and 3]
Measured: up to 10 years after treatment completion
Side effects of the combination of mini-hyperCVD and venetoclax plus capivasertib [Cohort 2 and 3]
Summary of dose limiting toxicities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: This will be assessed after all participants have completed treatment (an average of about 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start17 Mar 2026 (estimated)
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caner Saygin, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294677
- Sponsor's protocol ID
- IRB25-1773
- Acronym
- CAVALRY
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL
- ClinicalTrials.gov ID
- NCT07294677
- Acronym / sponsor ID
- CAVALRY / IRB25-1773
- Keywords
- Chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 17 Mar 2026 (estimated)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 19 Dec 2025 (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 is a 3-part study to assess the safety of adding capivasertib to a standard of care treatment regimen consisting of venetoclax and low-intensity chemotherapy. This chemotherapy regimen called mini-hyperCVD consists of the chemotherapy drugs, cyclophosphamide, vincristine, dexamethasone; (part A) alternating with high-dose methotrexate and cytarabine (part B) administered approximately every 28 days.
In the first part of the study (Cohort 1), the study seeks to determine the recommended dose of capivasertib that can be safely given with venetoclax and chemotherapy. Several doses of capivasertib may be tested in small groups of subjects in this part of the study. The dose tested will be increased or lowered depending on types and frequency of side effects seen until the best, safe dose is found.
Once the recommended, safe dose of capivasertib is found, the study will move on to the second part (Cohort 2) and will treat additional participants to learn more about the safety of giving these drugs together.
If the combination is determined to be safe overall, the study will move on to the third part (Cohort 3). In this part of the study, participants will be randomized to receive the mini-hyperCVD and venetoclax alone or with capivasertib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Dose Escalation (Dose Level 1) | Experimental | Drug: Capivasertib, Drug: Venetoclax, Drug: Rituximab, Drug: Blinatumomab, Drug: Nelarabine, Drug: mini-hyperCVDIn this arm, a dose of 320 mg dose of capivasertib will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen. |
| Cohort 1 - Dose Escalation (Dose Level 2) | Experimental | Drug: Capivasertib, Drug: Venetoclax, Drug: Rituximab, Drug: Blinatumomab, Drug: Nelarabine, Drug: mini-hyperCVDIn this arm, a dose of 400 mg dose of capivasertib will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen. |
| Cohort 1 - Dose Escalation (Dose Level -1) | Experimental | Drug: Capivasertib, Drug: Venetoclax, Drug: Rituximab, Drug: Blinatumomab, Drug: Nelarabine, Drug: mini-hyperCVDIn this arm, a dose of 200 mg dose of capivasertib will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen. |
| Cohort 2 (Expansion) | Experimental | Drug: Capivasertib, Drug: Venetoclax, Drug: Rituximab, Drug: Blinatumomab, Drug: Nelarabine, Drug: mini-hyperCVDIn this arm, the best, safe dose of capivasertib found after completion of enrollment to dose escalation (cohort 1) arms, will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen. |
| Cohort 3 -- Arm 1 -- mini-hyperCVD + venetoclax (Randomized) | Active comparator | Drug: Venetoclax, Drug: Rituximab, Drug: Blinatumomab, Drug: Nelarabine, Drug: mini-hyperCVDParticipants randomized to this arm will receive mini-hyperCVD + venetoclax. |
| Cohort 3 -- Arm 2 -- mini-hyperCVD + venetoclax + capivasertib (Randomized) | Experimental | Drug: Capivasertib, Drug: Venetoclax, Drug: Rituximab, Drug: Blinatumomab, Drug: Nelarabine, Drug: mini-hyperCVDParticipants randomized to this arm will receive mini-hyperCVD + venetoclax and capivasertib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
- 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.
Key exclusion criteria (43 listed)
- 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
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 |
|---|---|---|
| CapivasertibAlso: TRUQAPCapivasertib taken by mouth, twice daily. Dosing will occur on a 4 days on, 3 day off schedule. | Drug | Cohort 1 - Dose Escalation (Dose Level -1), Cohort 1 - Dose Escalation (Dose Level 1), Cohort 1 - Dose Escalation (Dose Level 2), Cohort 2 (Expansion), Cohort 3 -- Arm 2 -- mini-hyperCVD + venetoclax + capivasertib (Randomized) |
| VenetoclaxAlso: VENCLEXTAVenetoclax will be taken by mouth, once daily. | Drug | Cohort 1 - Dose Escalation (Dose Level -1), Cohort 1 - Dose Escalation (Dose Level 1), Cohort 1 - Dose Escalation (Dose Level 2), Cohort 2 (Expansion), Cohort 3 -- Arm 1 -- mini-hyperCVD + venetoclax (Randomized), Cohort 3 -- Arm 2 -- mini-hyperCVD + venetoclax + capivasertib (Randomized) |
| RituximabAlso: RITUXANSome participants will receive rituximab by IV infusion, two doses per cycle during the first four cycles. Whether or not this will be given to participants with leukemia cells that express a protein called CD20. | Drug | Cohort 1 - Dose Escalation (Dose Level -1), Cohort 1 - Dose Escalation (Dose Level 1), Cohort 1 - Dose Escalation (Dose Level 2), Cohort 2 (Expansion), Cohort 3 -- Arm 1 -- mini-hyperCVD + venetoclax (Randomized), Cohort 3 -- Arm 2 -- mini-hyperCVD + venetoclax + capivasertib (Randomized) |
| BlinatumomabAlso: BLINCYTOSome participants will receive cycles of blinatumomab by IV continuous infusion after the initial venetoclax plus chemotherapy phase for a 42-day cycle. Each cycle includes 28 days of blinatumomab dosing followed by a 14-day rest period. This will be given to participants that have a certain type of leukemia call CD19+ B-lineage ALL and who experience a complete remission. | Drug | Cohort 1 - Dose Escalation (Dose Level -1), Cohort 1 - Dose Escalation (Dose Level 1), Cohort 1 - Dose Escalation (Dose Level 2), Cohort 2 (Expansion), Cohort 3 -- Arm 1 -- mini-hyperCVD + venetoclax (Randomized), Cohort 3 -- Arm 2 -- mini-hyperCVD + venetoclax + capivasertib (Randomized) |
| NelarabineAlso: ARRANONSome participants in Cohorts 1 and 2 will receive nelarabine after cycles 2 and 4 at the discretion of their treating physician. | Drug | Cohort 1 - Dose Escalation (Dose Level -1), Cohort 1 - Dose Escalation (Dose Level 1), Cohort 1 - Dose Escalation (Dose Level 2), Cohort 2 (Expansion), Cohort 3 -- Arm 1 -- mini-hyperCVD + venetoclax (Randomized), Cohort 3 -- Arm 2 -- mini-hyperCVD + venetoclax + capivasertib (Randomized) |
| mini-hyperCVDParticipants will receive 8 cycles of chemotherapy consisting of the following drugs. They will receive the part A regimen and part B regimen in alternating cycles. Part A: cyclophosphamide, vincristine, dexamethasone Part B: high dose methotrexate and cytarabine. | Drug | Cohort 1 - Dose Escalation (Dose Level -1), Cohort 1 - Dose Escalation (Dose Level 1), Cohort 1 - Dose Escalation (Dose Level 2), Cohort 2 (Expansion), Cohort 3 -- Arm 1 -- mini-hyperCVD + venetoclax (Randomized), Cohort 3 -- Arm 2 -- mini-hyperCVD + venetoclax + capivasertib (Randomized) |
Primary outcome
Safety of the combination of mini-hyperCVD and venetoclax plus capivasertib [Cohort 1]
Time frame: 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]
Time frame: 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]
Time frame: 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
6 secondary outcomes
Rate of clinical remission (CR) [Cohort 1]
Time frame: This will be assessed after all participants have completed treatment (an average of about 8 months)
Rate of clinical remission with incomplete count recovering (CRi) [Cohort 1]
Time frame: This will be assessed after all participants have completed treatment (an average of about 8 months)
Rate of CR with measurable residual disease (MRD) negativity [Cohort 1]
Time frame: This will be assessed after all participants have completed treatment (an average of about 8 months)
Progression free survival [All Cohorts]
Time frame: up to 10 years after treatment completion
Overall survival [Cohort 2 and 3]
Time frame: up to 10 years after treatment completion
Side effects of the combination of mini-hyperCVD and venetoclax plus capivasertib [Cohort 2 and 3]
Time frame: This will be assessed after all participants have completed treatment (an average of about 8 months)
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 4 Mar 2026.
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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.
Caner Saygin study chair
University of Chicago
1 site 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 Capivasertib, Venetoclax and Rituximab in people with Leukemia and Lymphoma, run by University of Chicago at 1 site 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 9 inclusion and 43 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Clinical Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the combination of mini-hyperCVD and venetoclax plus capivasertib [Cohort 1] (time frame: After all cohort 1 participants have completed 2 28-day cycles of study treatment). The study lists 3 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 4 Mar 2026.