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Monoclonal Antibodies
cRIB Protocol for Pediatric Leukemia
Phase 2
Recruiting
Led By David McCall, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial tests if a combo of drugs can help control blood cancer.
Who is the study for?
This trial is for pediatric to young adult patients (1-25 years old) with relapsed or refractory B-cell lineage acute lymphocytic leukemia. They must have a certain level of physical ability, proper liver and kidney function, and not be pregnant or breastfeeding. Participants need to use effective contraception and cannot have uncontrolled infections, HIV, hepatitis B/C, severe heart conditions, active GvHD requiring treatment, or other serious medical issues.Check my eligibility
What is being tested?
The study tests mini hyper-CVD chemotherapy combined with intrathecal chemo and condensed doses of rituximab, blinatumomab, inotuzumab ozogamicin (cRIB). It aims to see if this regimen can control the disease better in those who can't receive standard treatments due to intolerance or risk factors.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site; bone marrow suppression leading to low blood cell counts; increased risk of infections; nausea; vomiting; hair loss; mouth sores; liver toxicity which may affect organ function; allergic reactions to medication components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: Leukemia CNS1 or 2Experimental Treatment11 Interventions
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.
Group II: Leukemia CNS 3Experimental Treatment11 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Vincristine
2003
Completed Phase 4
~2910
Blinatumomab
2014
Completed Phase 3
~1210
Cyclophosphamide
1995
Completed Phase 3
~3770
Pegfilgrastim
2013
Completed Phase 3
~4410
Mercaptopurine
2012
Completed Phase 4
~12330
Prednisone
2014
Completed Phase 4
~2370
Methotrexate
2013
Completed Phase 4
~3800
Cytarabine
2016
Completed Phase 3
~3310
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,447 Total Patients Enrolled
451 Trials studying Leukemia
31,491 Patients Enrolled for Leukemia
David McCall, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am still recovering from my last cancer treatment.I have Down syndrome or a bone marrow failure condition.I have leukemia in my brain but don't feel any symptoms.I am currently experiencing symptoms of Graft-versus-Host Disease.I am between 1 and 24 years old.I have a history of certain types of cancer or leukemia.I am a young patient with relapsed or treatment-resistant B-ALL and cannot take anthracyclines or PEG-asparaginase.I can do most activities but need help with some, regardless of my age.I do not have any ongoing, untreated infections.I have a specified heart condition.I have a history of heart disease.I have an active hepatitis B or C infection or I am HIV positive.I am not willing to use birth control.I have a serious brain condition that is not under control.I am not pregnant and agree to use birth control.I am willing and able to follow the study's requirements.I have liver cirrhosis, active liver disease, or I actively abuse alcohol.My blood or bone marrow has cells that are CD19 and CD22 positive.
Research Study Groups:
This trial has the following groups:- Group 1: Leukemia CNS1 or 2
- Group 2: Leukemia CNS 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are geriatric candidates being considered for enrollment in this trial?
"This research is searching for participants between the age of 1 and 25 years."
Answered by AI
Has Leukemia CNS 3 been cleared for market access by the FDA?
"Considering the Phase 2 nature of this trial, our team at Power concluded that Leukemia CNS 3 is likely safe based on existing data, scoring it a 2."
Answered by AI
Are additional individuals being sought for enrollment in this study?
"Sadly, as reported on clinicaltrials.gov this medical research effort is not currently accepting patients into the trial. The study first appeared on April 30th 2023 and was last updated on December 1st 2022. Even though it isn't recruiting at this time, there are still an abundance of studies actively looking for participants with 1502 open investigations available today."
Answered by AI
Who is eligible to take part in this research initiative?
"This medical trial has room for 27 individuals between infancy and 25 years of age who suffer from leukemia. To be considered, participants must meet the following conditions: they cannot have received anthracyclines or had an intolerant reaction to PEG-asparaginase; if applicable, 5%+ blasts in bone marrow/peripheral blood expressing CD19 and CD22; Lansky ≥ 50 (for those under 16) or Karnofsky ≥50 (above); patients with asymptomatic CNS leukaemia can still participate; serum bilirubin ≤1.5xULN (up to 3xUL"
Answered by AI
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