Actively Recruiting
CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL
Led by University of Chicago · Updated on 2026-03-04
104
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Diagnosis of relapsed or refractory acute lymphoid leukemia or lymphoblastic lymphoma with at least 5% leukemic blasts or measurable extramedullary disease
- ECOG performance status between 0 and 2
- Adequate organ function as defined by the protocol
- At least 2 weeks since major surgery or radiation therapy
- Recovery from any significant side effects of previous investigational treatments
- Signed informed consent
- Use of effective contraception by females of childbearing potential during and for 8 months after treatment, and by males with female partners of reproductive potential during and for 5 months after treatment
You will not qualify if you...
- Presence of Philadelphia chromosome-positive ALL or Burkitt's leukemia/lymphoma
- Pregnant or breastfeeding
- Uncontrolled infections or infections not controlled for at least 7 days
- Active hepatitis B or C infection, or uncontrolled HIV infection
- Major surgery or radiation therapy within 2 weeks before starting study treatment
- Symptomatic central nervous system disease or spinal cord compression
- Concurrent active cancer requiring treatment that might affect study outcomes, with some exceptions
- Uncontrolled heart disease
- Uncontrolled diabetes mellitus (fasting blood glucose >160 mg/dL or random >250 mg/dL), type 1 diabetes, or insulin-dependent diabetes
- Other severe medical, psychiatric, or laboratory conditions that increase risk or interfere with study participation
- Inability to stop strong CYP3A inducers or certain fruit products within 3 days before starting venetoclax
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Clinical Trials Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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