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Phase II Study to Evaluate Safety and Efficacy of CB-103 With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-ALL or T-LBL | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Phase II Study to Evaluate Safety and Efficacy of CB-103 With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-ALL or T-LBL

A Phase II Study to Evaluate Safety and Efficacy of CB-103 in Combination With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)

NCT05464836•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

To learn if the combination of 2 study drugs, CB-103 and venetoclax, can help to control T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic leukemia (T-LBL) in adolescent and young adult patients

Detailed Description

Primary Objectives: * To characterize the safety and tolerability of CB-103 in combination with Venetoclax in adolescent (12 to 18 years) and adult (19 to 60 years) patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). * To assess the efficacy of CB-103 in combination with venetoclax by the overall response rate (ORR), defined as complete remission (CR), plus CR with incomplete blood count recovery (CRi) \[1\] plus partial remission (PR) \[2\], in adolescent, and young adult patients with relapsed/refractory T-ALL/T-LBL. Secondary Objectives: * To assess whether the ORR to CB-103 in combination with Venetoclax is dependent on pre-treatment expression of Notch and/or BCL2 pathway. * To determine the preliminary assessment of CB-103 in combination with Venetoclax by other efficacy parameters such as minimal residual disease (MRD), duration of response (DoR), overall survival (OS) and event-free survival (EFS) in adolescent and young adult patients with relapsed/refractory T-ALL/T-LBL. Exploratory Objectives: * To explore potential correlations of ORR to treatment and additional pharmacodynamic (PD) markers, i.e., other oncogenic pathway activations that may co-occur at the start of treatment. * To evaluate how many patients are able to transition to Hematopoietic Stem Cell Transplant (HSCT): * Either in the patients achieving CR after the induction and reinduction cycles; * Or in the patients with PR or stable disease (SD) after the induction and reinduction.

Eligibility

Age

12 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adolescent (12 to 18 years) and adult (19 to 60 years) participants who have relapsed or refractory T-cell lymphoblastic leukemia (T-ALL) or T-Cell lymphoblastic lymphoma (T-LBL) according to 2017 WHO classification \[29\] and NCCN v1 2021 \[30\]:
•Participants must have ≥ 5% blasts in the bone marrow as assessed by morphology on standard bone marrow biopsy and aspirate or less than 5% blasts in the bone marrow in presence of extramedullary relapse, excluding isolated central nervous system (CNS) relapse. However, if an adequate bone marrow sample cannot be obtained, participants may be enrolled if there is unequivocal evidence of leukemia with ≥ 5% blasts in the peripheral blood.
•Participants are eligible independently of Notch pathway activation in the leukemic blasts:
•however, a fresh marrow/blood sample must be obtained before starting the study treatment to classify the participants as being either Notch positive or negative.
•Leukemic blasts must express of at least 2 of the following immune phenotyping: CD1a, CD2, CD3, CD4, CD5, CD7, CD8, CD34, TCRαβ, TCRγδ, cyCD3
•Participants have adequate performance status (ECOG ≤2) for participants ≥16 years old, Lansky score \>50 for patients \<16 years old.
•Participants must be 12 to 60 years of age inclusive when signing the informed consent. For participants \< 18 years of age, parent or legally authorized representative (LAR) should be willing and able to give informed consent. Non-English speaking participants are eligible for whom consent process will follow institutional guidelines.
•Participants with asymptomatic CNS disease are eligible
•Participants must have adequate organ function and laboratory results (obtained within 14 days of enrollment):
•* Direct bilirubin ≤2 x upper limit of normal (ULN).
+8 more criteria

Exclusion Criteria

•Mixed phenotype leukemia (excluding T-ALL with myeloid antigen expression)
•History of another primary invasive malignancy that has not been definitively treated and in remission. Participants with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).
•Presence of clinically significant uncontrolled CNS pathology such as epilepsy, childhood seizure, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis.
•Participants with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 50% or with a history of absolute decrease in LVEF of ≥ 15 absolute percentage points are excluded.
•Medical history of cardiovascular disease such as
•* Clinically significant cardiac disease including congestive heart failure (NYHA class III or IV), arrhythmia or conduction abnormality requiring medication, or cardiomyopathy
•* Clinically uncontrolled hypertension Age Blood Pressure 12 to 13 = \>120/80mmHg \>13 = \>140/90mmHg
•* Complete left bundle branch block
•* Right bundle branch block + left anterior hemiblock
•* Congenital long QT syndrome
+22 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

April 6, 2023

Primary Completion Date

August 12, 2024

Completion Date

August 12, 2024

Last Updated

November 26, 2025

Enrollment

ACTUAL participants

Conditions

Leukemia, LymphoblasticLeukemia

Interventions

CB-103

DRUG

Venetoclax

DRUG

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

NCT06311227

Recurrent Hairy Cell LeukemiaRecurrent Hairy Cell Leukemia Variant

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RECRUITING

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

NCT00106925

Graft-versus-leukemiaGraft vs Host Disease+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Study to Evaluate Safety and Efficacy of CB-103 With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-ALL or T-LBL

Inclusion Criteria

Exclusion Criteria

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

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