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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05645718
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jul 14, 2023
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Leukemia CNS1 or 2
    Each study block, or cycle, is 28 days. Between every cycle below, Participants will have a 7-day rest period in which no study drug is given.
  • Experimental: Leukemia CNS 3
    Each study block, or cycle, is 28 days. Between every cycle below, Participants will have a 7-day rest period in which no study drug is given.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
David Mc Call, MD
[email protected]
713-792-6604
David Mc Call, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
M D Anderson Cancer Center· Houston, TX

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