ADCT-602 for B-Cell ALL
Trial Summary
Will I have to stop taking my current medications?
The trial requires that certain medications be stopped before starting the study. Specifically, any chemotherapy, systemic therapy (except for some like steroids and hydroxyurea), or radiotherapy should be stopped at least 14 days before starting the trial. Some maintenance treatments like mercaptopurine, oral methotrexate, vincristine, and tyrosine kinase inhibitors should be stopped at least 48 hours before the study begins.
What data supports the effectiveness of the drug ADCT-602 for B-Cell ALL?
Research shows that epratuzumab, a component of ADCT-602, has been effective in increasing remission rates in patients with relapsed acute lymphoblastic leukemia (ALL) when added to chemotherapy. In one study, the response rate increased from 17% to 52% with the addition of epratuzumab, suggesting it may enhance the effectiveness of treatment for B-Cell ALL.12345
What makes the drug ADCT-602 unique for treating B-Cell ALL?
ADCT-602 is unique because it combines epratuzumab, a monoclonal antibody that targets CD22 on B-cells, with a potent drug that can kill cancer cells. This approach specifically targets and disrupts B-cell function, potentially leading to better outcomes in B-Cell ALL compared to traditional chemotherapy alone.13467
What is the purpose of this trial?
This phase I/II trial studies the side effects and best dose of ADCT-602 in treating patients with B-cell lymphoblastic leukemia that has come back or does not respond to treatment. Monoclonal antibodies, such as ADCT-602, may interfere with the ability of tumor cells to grow and spread.
Research Team
Nitin Jain, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for patients with B-cell acute lymphoblastic leukemia that has returned or isn't responding to treatment. Eligible participants must have a certain level of marrow blast count, normal liver and heart function, not be pregnant or breastfeeding, agree to use effective contraception, and cannot have had a recent transplant or other cancer treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Phase I)
Evaluate the safety and determine the maximum tolerated dose (MTD) of ADCT-602 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia
Treatment (Phase II)
Determine the recommended dose of ADCT-602 and evaluate efficacy in terms of complete response (CR) with incomplete marrow recovery (CR/CRi) rate
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ADCT-602
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
ADC Therapeutics S.A.
Industry Sponsor