Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia

To learn if cyclophosphamide, vincristine, and dexamethasone (called mini hyper-CVD) in combination with intrathecal (delivered into the spine) chemotherapy (methotrexate, hydrocortisone, cytarabine) and compressed rituximab, blinatumomab, and inotuzumab ozogamicin (called cRIB) can help to control the disease.

Trial Details

NCT ID

NCT05645718

Phase

PHASE2

Sponsor

M.D. Anderson Cancer Center

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Cyclophosphamide
Vincristine
Blinatumomab
Methotrexate
Cytarabine
Mercaptopurine

Locations (sample)

Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

Pediatric, adolescent, or young adult patients with B-ALL as per NCCN v2.2021 and WHO classification in relapse or primary refractory and, either/b…
For leukemia: Patients must have ≥ 5% blasts expressing CD19 and CD22 in the bone marrow as assessed by morphology or flow cytometry. However, if a…
If patient does not have CD20, they can still be enrolled but will not receive rituximab.
Performance status: Lansky ≥ 50 for patients who are ≤ 16 years old and Karnofsky ≥ 50% for patients who are \> 16 years old.

For full eligibility, visit ClinicalTrials.gov.

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