RecruitingPhase 2NCT05645718

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

Phase II 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


Sponsor

M.D. Anderson Cancer Center

Enrollment

27 participants

Start Date

Jul 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 YearMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of targeted drugs — including rituximab, inotuzumab ozogamicin, and blinatumomab — as a chemotherapy-light regimen (called Pedi-cRIB) for children, teenagers, and young adults with relapsed or treatment-resistant B-cell acute lymphocytic leukemia (B-ALL) who cannot tolerate certain standard chemotherapy agents. **You may be eligible if...** - You are a child, adolescent, or young adult with B-cell ALL that has relapsed or not responded to initial treatment - Your leukemia cells express CD19 and CD22 proteins (confirmed by lab testing) - You are unable to receive anthracycline chemotherapy OR have an intolerance to PEG-asparaginase - Your general health is adequate (Lansky ≥ 50 for patients under 16; Karnofsky ≥ 50% for older patients) **You may NOT be eligible if...** - Your leukemia cells do not express CD19 or CD22 (CD20 absence is acceptable) - Your general health is too poor - You have uncontrolled serious organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Given by (IV) vein

DRUGVincristine

Given by (IV) vein

DRUGBlinatumomab

Given by (IV) vein

DRUGMethotrexate

Given by (IV) vein

DRUGCytarabine

Given by (IV) vein

DRUGMercaptopurine

Given by (IV) vein

DRUGPrednisone

Given by PO

DRUGPegfilgrastim

Given by (IV) vein

DRUGInotuzumab ozogamicin

Given by (IV) vein

DRUGRituximab

Given by (IV) vein

DRUGDexamethasone

Given by (IV) vein


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05645718


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