Actively Recruiting

Phase 2
Age: 1Year - 25Years
All Genders
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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-23

27

Participants Needed

1

Research Sites

337 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Year - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric, adolescent, or young adult patients with relapsed or primary refractory B-cell acute lymphoblastic leukemia (B-ALL)
  • Patients must have at least 5% blasts expressing CD19 and CD22 in bone marrow or peripheral blood
  • Patients without CD20 expression can enroll but will not receive rituximab
  • Lansky performance status of 50 or higher for patients 16 years old or younger
  • Karnofsky performance status of 50% or higher for patients older than 16 years
  • Patients with asymptomatic central nervous system leukemia are eligible
  • Age 1 year or older and less than 25 years
  • Total serum bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), or up to 3 times ULN for patients with Gilbert's syndrome
  • Adequate kidney function with estimated glomerular filtration rate of 60 mL/min/1.73 m2 or higher
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels up to 3 times ULN, or 5 times ULN if leukemic liver involvement is suspected
  • Females of childbearing potential must have a negative pregnancy test within 14 days before starting treatment
  • Agree to use effective contraception during the study and for specified times after treatment
  • Males must avoid sperm donation and use condoms during the study and for specified periods after treatment
  • Patients with cardiac disease preventing anthracycline use, including left ventricular ejection fraction below 50% or high cumulative doxorubicin dose
Not Eligible

You will not qualify if you...

  • History of secondary or other primary tumors, except curatively treated non-melanoma skin cancer or solid tumors with no active disease for 2 years
  • Clinically significant uncontrolled central nervous system conditions such as epilepsy or severe brain injuries
  • Cardiovascular disease including congestive heart failure or arrhythmia requiring medication
  • Uncontrolled active infections
  • Known active hepatitis B or C infection or HIV seropositivity
  • Liver cirrhosis, serious active liver disease, or suspected active alcohol abuse
  • Active acute or chronic graft-versus-host disease requiring systemic treatment or recent immunosuppression
  • Not fully recovered from prior chemotherapy, surgery, or radiation before study drugs
  • Pregnant or lactating females
  • Unwillingness to use effective contraception
  • Other severe uncontrolled medical or psychiatric conditions increasing study risk or interfering with results
  • Patients with Trisomy 21 or bone marrow failure syndromes
  • Prior allergic reaction to any study agents
  • Inability or unwillingness to comply with study visits, tests, and procedures
  • Currently enrolled in another clinical trial with investigational products

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

David McCall, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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