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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

NCT05645718 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cyclophosphamide

Given by (IV) vein

DRUG

Vincristine

Given by (IV) vein

DRUG

Blinatumomab

Given by (IV) vein

DRUG

Methotrexate

Given by (IV) vein

DRUG

Cytarabine

Given by (IV) vein

DRUG

Mercaptopurine

Given by (IV) vein

DRUG

Prednisone

Given by PO

DRUG

Pegfilgrastim

Given by (IV) vein

DRUG

Inotuzumab ozogamicin

Given by (IV) vein

DRUG

Rituximab

Given by (IV) vein

DRUG

Dexamethasone

Given by (IV) vein

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David McCall, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05645718 on ClinicalTrials.gov