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New treatment option for Leukemia
Official title CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL
ClinicalTrials.gov ID: NCT07294677
What this study is testing
What is Capivasertib?
Capivasertib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for leukemia.
Also referred to as TRUQAP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- COHORT 1 Patients with acute leukemia with lymphoid lineage (B-ALL, T-ALL, ETP-ALL, mixed phenotype or bi-phenotypic) or lymphoblastic lymphoma (B-...
- Bone marrow or peripheral blood involvement with ≥5% leukemic blasts. Patients with isolated extramedullary disease that is measurable by CT scan are...
- 18 years or older
- ECOG performance status 0-2
- Adequate organ function meeting protocol criteria
You likely can't join if
- 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...
- Major surgery or radiation therapy within 2 weeks prior to the first study dose
- Symptomatic central nervous system (CNS) disease or spinal cord compression
See the full eligibility criteria
Who can join
- COHORT 1 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Patients who cannot discontinue strong CYP3A inducers, grapefruit, grapefruit products, Seville oranges, or star fruit within the 3 days prior to starting venetoclax. Inclusion criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.