Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.
Kara L Davis, Catherine C Yao, Jessica A O Zimmerman...
https://pubmed.ncbi.nlm.nih.gov/41671463Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04747912
A Phase II Study of a Chemotherapy-Free Induction Regimen for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Incorporating Inotuzumab Ozogamicin
Led by University of Chicago · Updated on 2026-06-05
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the addition of an anti-cancer drug called inotuzumab ozogamicin (InO) to the treatment for adults newly diagnosed with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The goal is to find out if adding InO to standard induction treatment can help patients achieve quicker and complete molecular remission, meaning the disease is undetectable even with very sensitive tests. This is a Phase II clinical trial aiming to gather information on the effectiveness of InO in patients who have not yet received treatment for Ph+ ALL. All participants will receive the same initial 60-day induction and consolidation treatment, including dasatinib, dexamethasone, inotuzumab ozogamicin, and intrathecal methotrexate. After this phase, further treatment depends on each participant's response. Those in complete molecular remission (CMR) will receive dasatinib combined with POMP chemotherapy and intrathecal methotrexate, while those not in CMR will receive ponatinib with POMP chemotherapy and intrathecal methotrexate. Some participants may receive an additional cycle of inotuzumab after maintenance treatment if remission is not achieved. Participants will undergo regular assessments during the study, including monitoring for remission status and side effects. Researchers will measure outcomes such as the number of participants entering complete clinical remission at 60 days, overall survival, duration of response, progression-free survival, and the number achieving complete molecular remission at 180 days. Safety will also be monitored, especially for liver-related complications. The study is expected to continue until March 2028, and participants must follow scheduled visits and tests throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Newly diagnosed and untreated patient with Philadelphia chromosome-positive B-cell Acute Lymphoblastic Leukemia and CD22 expression on 20% or more of blasts.
- 18 years old or older.
- Bone marrow involvement with 20% or more lymphoblasts and confirmation of BCR-ABL1 gene via FISH or PCR testing.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate organ function confirmed by medical evaluation.
- At least 2 weeks since major surgery, radiation therapy, or participation in other investigational trials, with recovery from related toxicities.
- Voluntary informed consent signed before any study procedures.
- Females of childbearing potential must use effective contraception during treatment and for at least 8 months after last dose; males with female partners of reproductive potential must use contraception during treatment and for at least 5 months after last dose.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and study procedures.
You will not qualify if you...
- Isolated extramedullary disease.
- Burkitt's or mixed-lineage leukemia.
- Active central nervous system leukemia.
- Prior therapy for ALL except limited corticosteroids or hydroxyurea use and a single dose of intrathecal therapy.
- Current or chronic hepatitis B or C infection, or known HIV infection unless viral load is undetectable.
- Major surgery within 2 weeks before randomization.
- Unstable or severe uncontrolled medical conditions such as cardiac or pulmonary issues.
- Concurrent active malignancy other than certain skin, cervical, or prostate cancers.
- Uncontrolled cardiac disease or QTcF longer than 500 msec.
- History of chronic liver disease or hepatic veno-occlusive disease.
- Serious active infections or recent deep tissue infections.
- Use of medications that increase risk of Torsades de Pointes during treatment.
- Pregnant or breastfeeding females, or those not using effective contraception.
- Investigational site staff members or relatives and Pfizer employees involved in the trial.
- Participation in other investigational studies during active treatment phase.
- Other severe medical, psychiatric, or laboratory conditions judged unsuitable for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 60 days
Participants receive a chemotherapy-free induction and consolidation treatment regimen combining inotuzumab ozogamicin with other anti-cancer drugs including dasatinib, dexamethasone, and methotrexate over 60 days.
Multiple visits during 2 months for treatment administration and assessments
Maintenance
Duration - Up to 36 months
Participants receive maintenance treatment based on their response to induction therapy. This includes different drug combinations such as dasatinib or ponatinib with chemotherapy agents and intrathecal methotrexate, with additional inotuzumab cycles if remission is not achieved.
Regular visits for treatment and monitoring during maintenance phase
Trial Site Locations
Total: 1 location
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60615
Actively Recruiting
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Research Team
C
Cancer Clinical Trials Office
W
Wendy Stock, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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