Phase 2 Study on Obecabtagene Autoleucel for High-Risk B-cell Acute Lymphocytic Leukemia (ALL)
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT07053059
This clinical trial is exploring whether a new treatment called obecabtagene autoleucel (obe-cel) can help control high-risk B-cell Acute Lymphocytic Leukemia (ALL) when used after initial treatment. The study aims to see if this approach can improve outcomes for patients with newly diagnosed high-risk B-cell ALL.
Patient Parameters
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Program Overview
The purpose of this study is to find out if a new treatment, obecabtagene autoleucel (obe-cel), can help manage high-risk B-cell Acute Lymphocytic Leukemia (ALL) when given as a follow-up treatment after the first phase of therapy. This follow-up treatment is known as consolidation therapy and is used to strengthen the initial treatment's effects.
Description
The main goal of this study is to see how effective obecabtagene autoleucel, a type of CAR-T cell therapy, is in helping patients with newly diagnosed high-risk B-cell ALL stay free from cancer for 18 months after treatment. The study will also look at other important outcomes, such as overall survival rates over 24 months, and how well the treatment works in different types of B-cell ALL. For patients with Ph-negative B-cell ALL, the study will check if the cancer remains undetectable at 18 months using specific tests. For those with Ph-positive B-cell ALL, the study will also measure the response using additional tests. The safety of the treatment will be closely monitored throughout the study.
The study will also explore how the CAR-T cells behave in the body over time, how the immune system responds, and other factors that might affect the treatment's success. Participants will have regular check-ups and tests to monitor their health and the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Adults over 18 years old with high-risk B-cell ALL in first remission and less than 5% cancer cells in the bone marrow.
- Must have at least one high-risk feature, such as specific genetic changes or persistent cancer cells after initial treatment.
- Good overall health with a performance status of 0, 1, or 2.
- Adequate organ function, including specific levels for kidney and liver function tests.
- Cancer cells must show CD19 markers before joining the study.
- Patients with controlled leukemia in the central nervous system or other areas outside the bone marrow can participate.
Exclusion Criteria
- Women who are pregnant or breastfeeding cannot participate. Women of childbearing potential must have a negative pregnancy test.
- Patients with a history of Hepatitis B, Hepatitis C, or HIV infections, even if controlled, cannot participate. However, those with only a positive Hepatitis B core antibody test can join if their HBV DNA test is negative.
- Patients with active and uncontrolled diseases or infections, as determined by the doctor, cannot participate.
- Patients who are unable or unwilling to sign the consent form cannot participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | 77030 | Houston | Texas |
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