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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 1 Year – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: --To evaluate the clinical efficacy of the sequential combination of mini-hyper-CVD with inotuzumab ozogamicin and blinatumomab and rituximab in relapsed B-cell acute lymphoblastic leukemia (ALL) patients, based upon the complete response rate (CR). Secondary Objectives: * To summarize efficacy per response rate, overall survival (OS), event free survival (EFS), and minimal residual disease (MRD) negativity rate. * To evaluate the safety of this combination. Exploratory Objectives: --To summarize associations between genomic alterations in ALL (current biomarker expression of the disease) with relation to the incidence of transition to HSCT in patients with PR or stable disease (SD) after the induction cycle(s).

Conditions

• Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-14
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2022-12-09
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study