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OncoMatch/Clinical Trials/NCT05645718

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

Is NCT05645718 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for leukemia.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT05645718Data as of Jun 2026

Treatment: Cyclophosphamide · Vincristine · Blinatumomab · Methotrexate · Cytarabine · Mercaptopurine · Prednisone · Pegfilgrastim · Inotuzumab ozogamicin · Rituximab · DexamethasoneTo 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

BlinatumomabRituximab

Targeted therapy

Inotuzumab ozogamicin

Chemotherapy

CyclophosphamideVincristineMethotrexateCytarabineMercaptopurine

Other

PrednisonePegfilgrastimDexamethasone

Biomarker criteria

Required: CD19 expression (≥ 5% blasts)

Required: CD22 expression (≥ 5% blasts)

Allowed: CD20 expression

Demographics

Ages 1–25

Lab requirements

Kidney function

Estimated GFR ≥ 60 mL/min/1.73 m2 based on local institutional practice for age-appropriate determination

Liver function

Total serum bilirubin ≤1.5x ULN (≤3x ULN if Gilbert's syndrome); ALT/AST ≤3x ULN (≤5x ULN if suspected leukemic liver involvement)

Cardiac function

Left ventricular ejection fraction (EF) < 50% (as determined by the Biplane Simpson method) (but not per exclusion criteria 3.2.3.1), or who have received >450mg/m2 of doxorubicin and cannot receive anthracyclines

Total serum bilirubin ≤1.5x ULN. Patients with known Gilbert's syndrome may have a total bilirubin up to ≤3 x ULN. ALT/AST ≤3 x ULN; ≤5 x ULN in case of suspected leukemic liver involvement. Estimated GFR ≥ 60 mL/min/1.73 m2. Left ventricular ejection fraction (EF) < 50% (as determined by the Biplane Simpson method) (but not per exclusion criteria 3.2.3.1), or who have received >450mg/m2 of doxorubicin and cannot receive anthracyclines.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • M D Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05645718 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require CD19?

Yes, CD19 expression is a required biomarker for enrollment.

Does this trial require CD22?

Yes, CD22 expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 25 years or younger and at least 1 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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