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

Recruiting now Phase 2 Last updated 7 October 2025

What this trial tests

Phase 2 trial testing Cyclophosphamide in Leukemia in 27 participants. Currently enrolling.

Timeline

14 July 2023

Primary endpoint
31 December 2027

31 December 2029

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	14 July 2023
Primary completion	31 December 2027
Estimated completion	31 December 2029
Sites	1 location across United States

Drugs / interventions tested

• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Vincristine
• Blinatumomab
• Methotrexate
• Cytarabine — full drug profile →
• Mercaptopurine
• Prednisone (prednisone) — full drug profile →
• Pegfilgrastim
• Inotuzumab ozogamicin — full drug profile →
• Rituximab
• Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

• Leukemia — all drugs for Leukemia →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 1 to 25, any sex, with Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glycosylation Targeting: A Paradigm Shift in Cancer Immunotherapy.
   Ren X, Lin S, Guan F, Kang H. · · 2024 · cited 30× · PMID 38725856 · DOI 10.7150/ijbs.93806
2. Combination therapies for the optimisation of Bispecific T-cell Engagers in cancer treatment.
   Zhu WM, Middleton MR. · · 2023 · cited 23× · PMID 37599903 · DOI 10.1093/immadv/ltad013
3. Dose-Dense Mini-Hyper-CVD, Inotuzumab Ozogamicin and Blinatumomab Achieves Rapid MRD-Negativity in Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia.
   Short NJ, Jabbour E, Jamison T, Paul S, et al · · 2024 · cited 17× · PMID 38212207 · DOI 10.1016/j.clml.2023.12.016
4. Inotuzumab ozogamicin combined with chemotherapy in pediatric B-cell precursor CD22⁺ acute lymphoblastic leukemia: results of the phase IB ITCC-059 trial.
   Pennesi E, Brivio E, Ammerlaan ACJ, Jiang Y, et al · · 2024 · cited 15× · PMID 38186333 · DOI 10.3324/haematol.2023.284409
5. Immune Microenvironment in Childhood Cancers: Characteristics and Therapeutic Challenges.
   Pathania AS. · · 2024 · cited 9× · PMID 38927907 · DOI 10.3390/cancers16122201
6. Naked antibodies and antibody-drug conjugates: targeted therapy for childhood acute lymphoblastic leukemia.
   Brivio E, Bautista F, Zwaan CM. · · 2024 · cited 9× · PMID 38832425 · DOI 10.3324/haematol.2023.283815
7. Efficacy and safety of blinatumomab combination therapy in high-risk B-cell acute lymphoblastic leukemia: A systematic review and meta-analysis.
   Wang M, Yu X, Zou Z, He Y, et al · · 2026 · PMID 41947896 · DOI 10.3892/ol.2026.15552
8. Immune-related toxicity profile after haematopoietic stem cell transplantation in patients with B-ALL given combination immunotherapy with rituximab, inotuzumab and blinatumomab.
   Okeleji O, McCall D, Cuglievan B, Gibson A, et al · · 2026 · PMID 41582414 · DOI 10.1111/bjh.70350