CB-103 + Venetoclax for Lymphoblastic Leukemia

Phase 2

Waitlist Available

Led By Branko Cuglievan, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of study or average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, CB-103 and venetoclax, in adolescents and young adults with certain blood cancers that have not responded to other treatments. The drugs work together to stop cancer cell growth and make the cells die more easily. Venetoclax is used in treating various leukemias and lymphomas, known for its effectiveness but also for severe side effects like tumor lysis syndrome and neutropenia.

Who is the study for?

This trial is for adolescents and young adults aged 12-40 with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). Participants need a certain level of blasts in their bone marrow, must not have mixed phenotype leukemia, uncontrolled CNS pathology, active infections, severe liver disease, or be pregnant. They should have an ECOG performance status ≤2 if over 16 years old or Lansky score >50 if under.

What is being tested?

The study tests the combination of CB-103 and Venetoclax to see if they can control T-ALL/T-LBL in young patients. It's a phase II trial which means it focuses on the treatment's efficacy and safety. Patients will be classified as Notch positive or negative before starting treatment based on a fresh blood sample.

What are the potential side effects?

Potential side effects are not specified here but generally could include immune system suppression leading to increased infection risk, gastrointestinal issues affecting absorption of drugs like nausea and vomiting, potential liver toxicity, and possibly effects related to central nervous system involvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of study or average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of study or average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study or average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The efficacy of CB-103 in combination with venetoclax will be determined by studying the overall response rate (ORR) of the participants

The safety and tolerability of CB-103 in combination with Venetoclax in adolescent and young adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) .