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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
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) .
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CB-103+VenetoclaxExperimental Treatment2 Interventions
Control T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic leukemia (T-LBL) in adolescent and young adult patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2240
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,806 Total Patients Enrolled
464 Trials studying Leukemia
31,793 Patients Enrolled for Leukemia
Branko Cuglievan, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
154 Total Patients Enrolled
3 Trials studying Leukemia
84 Patients Enrolled for Leukemia
Miriam Garcia, DOPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well according to recent tests.I am aged 12-60 with relapsed or refractory T-cell leukemia or lymphoma.I have another cancer that is not in remission and hasn't been fully treated.I am on long-term steroids for another health issue.I have a serious brain condition that is not under control.I have not had chemotherapy, radiotherapy, or experimental treatments recently.I have a history of heart disease.My heart's pumping ability is below 50% or has dropped by 15% or more.I still experience nausea, vomiting, or diarrhea from past treatments.I am not pregnant and agree to use birth control.I have brain involvement from my cancer but no symptoms.I have an active hepatitis B or C infection or I am HIV positive.I do not have severe liver disease or a history of heavy alcohol use.My leukemia is of mixed type, not just T-ALL with myeloid markers.I am physically active and can carry out daily activities.My bone marrow has ≥ 5% blasts, or less with an extramedullary relapse.I have ongoing or returning stomach or intestine problems.I am unwilling to use birth control.I have a digestive condition that affects how medicines work in my body.I do not have any ongoing, untreated infections.I do not have any severe, uncontrolled health or mental health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: CB-103+Venetoclax
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.