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New treatment option for Leukemia
Official title 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
ClinicalTrials.gov ID: NCT05645718
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for leukemia.
Also referred to as Cytoxan®, Neosar®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- Pediatric, adolescent, or young adult patients with B-ALL as per NCCN v2.2021 and WHO classification in relapse or primary refractory and...
- 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...
- 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.)
You likely can't join if
- 3.2.3.1), or who have received \>450mg/m2 of doxorubicin and cannot receive anthracyclines. Exclusion Criteria:
- 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...
- Medical history of cardiovascular disease such as: ° Clinically significant cardiac disease including congestive heart failure (NYHA class III or IV)...
See the full eligibility criteria
Who can 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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
What rules you out
- 3.2.3.1), or who have received \>450mg/m2 of doxorubicin and cannot receive anthracyclines. Exclusion Criteria:
- 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...
- 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
- 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...
- 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...
- Females who are pregnant or lactating.
- Male or female people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.