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

ConditionLeukemia

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age1-25

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric, adolescent, or young adult patients with B-ALL as per NCCN v2.2021 and WHO classification in relapse or primary refractory and, either/both of the following: • Unable to receive anthracyclines (see section 3.1.8) or is PEG-asparaginase intolerant.

For leukemia: Patients must have ≥ 5% blasts expressing CD19 and CD22 in the bone marrow as assessed by morphology or flow cytometry. However, if an adequate bone marrow sample cannot be obtained, patients may be enrolled if there is unequivocal evidence of leukemia with ≥ 5% blasts in the peripheral blood.

If patient does not have CD20, they can still be enrolled but will not receive rituximab.

Performance status: Lansky ≥ 50 for patients who are ≤ 16 years old and Karnofsky ≥ 50% for patients who are > 16 years old.

Disqualifiers

Curatively treated non-melanomatous skin cancer

Other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 2 years

Presence of clinically significant uncontrolled CNS pathology such as epilepsy, childhood seizure, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis. Presence of the following are allowed: headaches, vomiting, nerve palsy

Patients with uncontrolled, active infections (viral, bacterial, or fungal). Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable.

Trial design

Design model

Parallel

Treatments tested in this trial

Cyclophosphamide
Drug
Given by (IV) vein
Vincristine
Drug
Given by (IV) vein
Blinatumomab
Drug
Given by (IV) vein
Methotrexate
Drug
Given by (IV) vein
Cytarabine
Drug
Given by (IV) vein
Mercaptopurine
Drug
Given by (IV) vein
Prednisone
Drug
Given by PO
Pegfilgrastim
Drug
Given by (IV) vein
Inotuzumab ozogamicin
Drug
Given by (IV) vein
Rituximab
Drug
Given by (IV) vein
Dexamethasone
Drug
Given by (IV) vein

Treatment groups

27 Participants

are divided into 2 treatment groups

Group A: Leukemia CNS1 or 2Experimental treatment 11 interventions

Group B: Leukemia CNS 3Experimental treatment 11 interventions

Trial outcomes

Primary outcomes

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

through study completion; an average of 1 year.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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