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CB-103 + Venetoclax for Lymphoblastic Leukemia
Phase 2
Recruiting
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
Study Summary
This trial will test if two drugs, CB-103 and venetoclax, can help control T-cell acute lymphoblastic leukemia or T-cell lymphoblastic leukemia in young patients.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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) .
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
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
~1990
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,287 Total Patients Enrolled
451 Trials studying Leukemia
31,438 Patients Enrolled for Leukemia
Branko Cuglievan, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
128 Total Patients Enrolled
1 Trials studying Leukemia
58 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned CB-103 for use?
"Our team at Power assigned CB-103 a score of 2 in regards to safety, as there is evidence that it has been proven safe but no clinical data yet demonstrating effectiveness."
Answered by AI
Are the enrollees for this trial restricted to those aged 40 or younger?
"The requirements for enrolment state that potential participants in this trial must be between 12 and 40 years old. Clinical trials involving those aged below 18 encompass 465 studies, while 1163 are available to individuals 65 or older."
Answered by AI
Could I be a participant in this investigation?
"This clinical trial is seeking 30 candidates between the ages of twelve and forty who are battling leukemia. Patients must meet certain conditions to be accepted, such as having a bone marrow biopsy that shows ≥ 5% blasts or unequivocal evidence for the same in peripheral blood. Additionally, leukemic blasts should indicate at least two immunophenotyping markers from CD1a, CD2, CD3, CD4 etc., they must have an ECOG score ≤ 2 if over 16 years old & Lansky Score > 50 if below sixteen; there needs to be assurance of four months life expectancy; and any patients with CNS disease but remain as"
Answered by AI
Is this research endeavor currently recruiting participants?
"According to data hosted on clinicaltrials.gov, the recruitment phase of this medical trial has concluded and is no longer accepting new patients. This study was launched on December 30th 2022 with its last update taking place July 19th 2022. Luckily, 1470 other studies are presently seeking volunteers for participation."
Answered by AI
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