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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 up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2650
Vincristine
2003
Completed Phase 4
~2970
Blinatumomab
2014
Completed Phase 3
~1230
Cyclophosphamide
2010
Completed Phase 4
~2310
Pegfilgrastim
2013
Completed Phase 3
~4440
Mercaptopurine
2012
Completed Phase 4
~12550
Prednisone
2014
Completed Phase 4
~2500
Methotrexate
2019
Completed Phase 4
~4400
Cytarabine
2016
Completed Phase 3
~3330
Rituximab
1999
Completed Phase 4
~2990
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,197 Total Patients Enrolled
464 Trials studying Leukemia
31,772 Patients Enrolled for Leukemia
David McCall, MDPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
90 Total Patients Enrolled
3 Trials studying Leukemia
66 Patients Enrolled for Leukemia
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.
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