CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07294677
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capivasertib — DRUG
    Capivasertib taken by mouth, twice daily. Dosing will occur on a 4 days on, 3 day off schedule.
  • Venetoclax — DRUG
    Venetoclax will be taken by mouth, once daily.
  • Rituximab — DRUG
    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.
  • Blinatumomab — DRUG
    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.
  • Nelarabine — DRUG
    Some participants in Cohorts 1 and 2 will receive nelarabine after cycles 2 and 4 at the discretion of their treating physician.
  • mini-hyperCVD — DRUG
    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 Details

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.

Key Dates

Start date
Mar 17, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2032
Completion
Mar 31, 2032

Study Design

Enrollment
104 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 - Dose Escalation (Dose Level 1)
    In this arm, a dose of 320 mg dose of capivasertib will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen.
  • Experimental: Cohort 1 - Dose Escalation (Dose Level 2)
    In this arm, a dose of 400 mg dose of capivasertib will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen.
  • Experimental: Cohort 1 - Dose Escalation (Dose Level -1)
    In this arm, a dose of 200 mg dose of capivasertib will be tested in combination with venetoclax and mini-hyperCVD chemotherapy regimen.
  • Experimental: Cohort 2 (Expansion)
    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.
  • Active Comparator: Cohort 3 -- Arm 1 -- mini-hyperCVD + venetoclax (Randomized)
    Participants randomized to this arm will receive mini-hyperCVD + venetoclax.
  • Experimental: Cohort 3 -- Arm 2 -- mini-hyperCVD + venetoclax + capivasertib (Randomized)
    Participants randomized to this arm will receive mini-hyperCVD + venetoclax and capivasertib.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
[email protected]
855-702-8222
Caner Saygin (PRINCIPAL_INVESTIGATOR)

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By condition
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By research site
University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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