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AzTrials

LeukemiaPhase 2NCT05645718

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

A Phase 2 study testing Cyclophosphamide, Vincristine and Blinatumomab in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 25 years
Conditions the study is for
Leukemia
What is being tested?
Cyclophosphamide, Vincristine and Blinatumomab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
14 Jul 2023to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
  • Patients with asymptomatic CNS leukemia are eligible (see also Exclusion Criterion 3.2.2.)
  • Age > = 1 years of age and less than 25 years of age.
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  • The following baseline laboratory data:
  • Total serum bilirubin ≤1.5x upper limit of normal (ULN). Patients with known Gilbert's syndrome may have a total bilirubin up to ≤3 x ULN.
  • Adequate renal function per age51 unless related to the disease. Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 based on local institutional practice for age-appropriate determination (eg, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤3 x ULN; ≤5 x ULN in case of suspected leukemic liver involvement
  • Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and 30 days after the last treatment and 8 months after the last dose of inotuzumab and 12 months after the last dose of rituximab. Effective methods of birth control include:
  • Birth control pills, shots, implants (placed under the skin by a health care provider) or patches (placed on the skin)
  • Intrauterine devices (IUDs)
  • Condom or occlusive cap (diaphragm or cervical/vault caps) used with Spermicide
  • Abstinence
  • Males need to inform the doctor right away if the partner becomes pregnant or suspects pregnancy. While in this study and for 30 days after the last treatment the patient should not donate sperm for the purposes of reproduction. He will need to use a condom while in this study and for 30 days after the last treatment and 5 months after the last dose of inotuzumab.
  • Patients with cardiac disease, include but not limited to: (Left ventricular ejection fraction (EF) < 50% (as determined by the Biplane Simpson method) (but not per exclusion criteria 3.2.3.1), or who have received >450mg/m2 of doxorubicin and cannot receive anthracyclines.

Who cannot join

  • Past or current history of a secondary or other primary tumor or a chronic myeloid leukemia (CML) blast crisis with exception of:
  • 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
  • Medical history of cardiovascular disease such as:
  • ° Clinically significant cardiac disease including congestive heart failure (NYHA class III or IV) or arrhythmia or conduction abnormality requiring medication
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  • 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.
  • Known active hepatitis B or C infection or known seropositivity for HIV.
  • Patients with liver cirrhosis or other serious active liver disease or with suspected active alcohol abuse.
  • Active acute/chronic Graft-versus-Host Disease (GvHD) requiring systemic treatment; or receiving immunosuppression for GvHD prophylaxis within 2 weeks from the start of study therapy.
  • If patient has not recovered (as deemed by the investigator) from previous chemotherapy, surgery, radiation before the start of study drugs.
  • ° To reduce the circulating blast count or palliation, the following are allowed prior to starting: Single dose intravenous cytarabine, steroids or hydroxyurea. No washout necessary for these agents.
  • Females who are pregnant or lactating.
  • Male or female subjects of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with institution's standards.
  • Other severe, uncontrolled acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated Protocol 2022-0312 V3 Dated 11/9/2023 Property of Leukemia at MD Anderson 17 with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study.
  • Patients with Trisomy 21, or bone marrow failure syndromes are not eligible.
  • Prior history of allergic reaction to any of the agents.
  • Patients who are unable or unwilling to comply with all study requirements for clinical visits, examinations, tests, and procedures.
  • Patients may be excluded if they are currently enrolled in another ongoing clinical trial with investigational products

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David McCall, MD contact

(713) 792-6604

dmccall1@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    David Mc Call, MD, 713-792-6604, dmccall1@mdanderson.org

    David Mc Call, MD

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the 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
Medical subject headings
Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    Also called Cytoxan®, Neosar®

    Given by (IV) vein

  • VincristineDrug

    Given by (IV) vein

  • BlinatumomabDrug

    Given by (IV) vein

  • MethotrexateDrug

    Given by (IV) vein

  • CytarabineDrug

    Also called Ara-C, Cytosar®, DepoCyt™, Cytosine arabinosine hydrochloride

    Given by (IV) vein

  • MercaptopurineDrug

    Also called 6-mercaptopurine, Purinethol®, 6-MP

    Given by (IV) vein

  • PrednisoneDrug

    Given by PO

  • PegfilgrastimDrug

    Also called NeulastaTM, PEG-G-CSF

    Given by (IV) vein

  • Inotuzumab ozogamicinDrug

    Also called CMC-544

    Given by (IV) vein

  • RituximabDrug

    Also called Rituxan

    Given by (IV) vein

  • DexamethasoneDrug

    Also called Decadron

    Given by (IV) vein

Study groups in NCT05645718
Study groupRoleWhat they receive
Leukemia CNS1 or 2ExperimentalEach 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.
Receives: Drug: Cyclophosphamide; Drug: Vincristine; Drug: Blinatumomab; Drug: Methotrexate; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Prednisone; Drug: Pegfilgrastim; Drug: Inotuzumab ozogamicin; Drug: Rituximab; Drug: Dexamethasone
Leukemia CNS 3ExperimentalEach 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.
Receives: Drug: Cyclophosphamide; Drug: Vincristine; Drug: Blinatumomab; Drug: Methotrexate; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Prednisone; Drug: Pegfilgrastim; Drug: Inotuzumab ozogamicin; Drug: Rituximab; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: through study completion; an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start14 Jul 2023
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05645718
Sponsor's protocol ID
2022-0312
Other IDs
NCI-2022-10168
Status last verified
Sep 2026
First submitted
29 Nov 2022
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.

    PubMed 41671463

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide, Vincristine and Blinatumomab in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David McCall, MD ((713) 792-6604, dmccall1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05645718, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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