Improving treatment for infants with acute lymphoblastic leukemia
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
PHASE1; PHASE2 · Stanford University · NCT05848687
This study is testing a new treatment using immunotherapy and several medications to see if it can help infants with acute lymphoblastic leukemia feel better and improve their chances of recovery.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | N/A to 1 Year |
| Sex | All |
| Sponsor | Stanford University (other) |
| Drugs / interventions | chemotherapy, blinatumomab, immunotherapy |
| Locations | 24 sites (Phoenix, Arizona and 23 other locations) |
| Trial ID | NCT05848687 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the treatment protocol for infants diagnosed with acute lymphoblastic leukemia (ALL) by testing the effectiveness of an immunotherapy called blinatumomab, which targets CD19 on leukemia cells. The study will involve a combination of medications including dexamethasone, mitoxantrone, PEG asparaginase, bortezomib, and vorinostat. It is designed for infants aged 365 days or younger with newly diagnosed CD19 positive ALL or acute undifferentiated leukemia, with limited prior therapy. The goal is to clear persistent leukemia and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 365 days or younger with newly diagnosed CD19 positive acute lymphoblastic leukemia or acute undifferentiated leukemia.
Not a fit: Patients with prior therapy beyond specified limits, mature B-cell ALL without a KMT2A rearrangement, acute myelogenous leukemia, T-cell ALL, or Down syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and outcomes for infants with acute lymphoblastic leukemia.
How similar studies have performed: Other studies utilizing immunotherapy approaches for leukemia have shown promising results, indicating potential success for this novel treatment strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is ≤ 365 days of age at the time of diagnosis. * Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia. Subjects with bilineage or biphenotypic acute leukemia are eligible provided they express CD19. Patients with CD19 positive mature B-cell ALL who carry a KMT2A rearrangement are eligible. * Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less, one dose of vincristine, and one dose of intrathecal chemotherapy. * Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines. Exclusion Criteria: * Patients with prior therapy, other than therapy specified in inclusion criteria. * Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL. * Patients with Down syndrome. * Inability or unwillingness of legal guardian/representative to give written informed consent
Where this trial is running
Phoenix, Arizona and 23 other locations
- Phoenix Children's Hospital — Phoenix, Arizona, United States (RECRUITING)
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (RECRUITING)
- Children's Hospital Los Angeles — Los Angeles, California, United States (RECRUITING)
- Valley Children's Hospital — Madera, California, United States (RECRUITING)
- Children's Hospital of Orange County — Orange, California, United States (RECRUITING)
- Stanford University — Palo Alto, California, United States (RECRUITING)
- Rady Children's Hospital San Diego — San Diego, California, United States (NOT_YET_RECRUITING)
- Arnold Palmer Hospital for Children — Orlando, Florida, United States (RECRUITING)
- Children's Hospital of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- Novant Health - Hemby Children's Hospital — Charlotte, North Carolina, United States (NOT_YET_RECRUITING)
- Doernbecher Children's Hospital — Portland, Oregon, United States (RECRUITING)
- Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States (NOT_YET_RECRUITING)
- MD Anderson — Houston, Texas, United States (RECRUITING)
- University of Texas Health Science Center San Antonio — San Antonio, Texas, United States (RECRUITING)
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (NOT_YET_RECRUITING)
- Children's Hospital of The King's Daughters — Norfolk, Virginia, United States (RECRUITING)
- Alberta Children's Hospital — Calgary, Alberta, Canada (NOT_YET_RECRUITING)
- Stollery Children's Hospital — Edmonton, Alberta, Canada (NOT_YET_RECRUITING)
- BC Children's Hospital — Vancouver, British Columbia, Canada (NOT_YET_RECRUITING)
- McMaster Children's Hospital — Hamilton, Ontario, Canada (NOT_YET_RECRUITING)
- CHU Sainte-Justine — Montreal, Quebec, Canada (NOT_YET_RECRUITING)
- Montreal Children's Hospital — Montreal, Quebec, Canada (NOT_YET_RECRUITING)
- Chu De Quebec — Québec, Quebec, Canada (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Tanja A Gruber, MD, PhD — Stanford University
- Study coordinator: Tanja A Gruber, MD, PhD
- Email: tagruber@stanford.edu
- Phone: 650 723 5535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphoblastic Leukemia