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MDM2 Inhibitor
Idasanutlin + Chemotherapy/Venetoclax for Leukemia and Solid Cancers
Phase 1 & 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Additional Inclusion Criteria for Patients with Leukemia: Bone marrow with ≥5% lymphoblasts by morphologic assessment at screening
Adequate performance status: Participants <16 years of age: Lansky greater than or equal to (≥)50%; Patients ≥16 years of age: Karnofsky ≥50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of study drug to first documented occurrence of m3 marrow after cycle 1, failure to achieve cr/crp/cri after cycle 2, disease progression, relapse after achieving cr/crp/cri, or death from any cause, whichever occurs first (about 1 year)
Awards & highlights
Study Summary
This trial is studying idasanutlin, given alone or with other drugs, as a possible treatment for pediatric and young adult participants with solid tumors or leukemias.
Who is the study for?
This trial is for young individuals under 30 years old with relapsed or refractory acute leukemias or solid tumors, including neuroblastoma. They must have adequate organ function and agree to use contraception if of childbearing potential. Those with certain genetic syndromes, unstable brain metastases, recent anticancer therapies, or major surgeries are excluded.Check my eligibility
What is being tested?
The study tests Idasanutlin alone or combined with chemotherapy (Topotecan, Cytarabine) or Venetoclax in three parts: dose escalation to find the safest dose; safety run-in cohorts for neuroblastoma, AML & ALL; and expansion phases for further response assessment.See study design
What are the potential side effects?
Potential side effects include typical chemotherapy-related issues like nausea, fatigue, low blood cell counts leading to increased infection risk and bleeding problems. Idasanutlin may also cause unique side effects that will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia involves more than 5% lymphoblasts in my bone marrow.
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I am under 16 with a Lansky score ≥50% or 16 and older with a Karnofsky score ≥50%.
Select...
My cancer has come back after treatment.
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I have at least one tumor that can be measured or seen on scans.
Select...
I am under 16 with a Lansky score above 50% or 16 and older with a Karnofsky score above 50%.
Select...
I am under 18 for part 1a, and under 30 for parts 1b, 2, and 3.
Select...
My cancer (neuroblastoma, AML, or precursor-B ALL) has not responded to standard treatments.
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My cancer has returned or worsened despite treatment, and there's no other therapy that can improve my life quality.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from initiation of study drug to first documented occurrence of m3 marrow after cycle 1, failure to achieve cr/crp/cri after cycle 2, disease progression, relapse after achieving cr/crp/cri, or death from any cause, whichever occurs first (about 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of study drug to first documented occurrence of m3 marrow after cycle 1, failure to achieve cr/crp/cri after cycle 2, disease progression, relapse after achieving cr/crp/cri, or death from any cause, whichever occurs first (about 1 year)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Dose-Limiting Toxicities (DLTs)
Number of Participants with at Least One Adverse Event, Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Parts 2 and 3: Complete Remission Rate Within 2 Cycles of Study Treatment in Participants with TP53 WT Leukemia
+2 moreSecondary outcome measures
Clinical Benefit Rate (CBR) in Participants with Solid Tumors (Including Neuroblastoma)
Complete Remission Rate in Participants with Leukemia Irrespective of TP53 Mutation Status
Duration of Objective Response in Participants with Leukemia
+9 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Neuroblastoma: Idasanutlin + VenetoclaxExperimental Treatment2 Interventions
Group II: Neuroblastoma: Idasanutlin + Cyclophosphamide + TopotecanExperimental Treatment3 Interventions
Group III: Dose Escalation: Solid Tumors: Idasanutlin Single AgentExperimental Treatment1 Intervention
Group IV: AML: Idasanutlin + VenetoclaxExperimental Treatment3 Interventions
Group V: AML: Idasanutlin + Fludarabine + CytarabineExperimental Treatment4 Interventions
Group VI: ALL: Idasanutlin + VenetoclaxExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
2017
Completed Phase 3
~2400
Cytarabine
2016
Completed Phase 3
~3310
Idasanutlin
2018
Completed Phase 2
~380
Venetoclax
2019
Completed Phase 3
~1990
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,089,016 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,464 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia has spread to my brain and spinal fluid.My blood and organs are functioning well.My leukemia involves more than 5% lymphoblasts in my bone marrow.I had major surgery less than 3 weeks ago or might need one during the study.I am not on medications that affect CYP2C8, CYP3A4, OATP1B1/B3, or P-gp.I am under 16 with a Lansky score ≥50% or 16 and older with a Karnofsky score ≥50%.I have Down syndrome, Li-Fraumeni syndrome, severe aplastic anemia, or a known bone marrow failure syndrome.I have been diagnosed with Burkitt-type acute lymphoblastic leukemia.I haven't taken blood thinners within 7 days or 5 half-lives before starting the study treatment.My cancer has come back after treatment.My cancer originated in the brain or spinal cord.I agree to use contraception or remain abstinent and not donate sperm during and after treatment.I have at least one tumor that can be measured or seen on scans.I have T-cell lymphoblastic leukemia.I have been diagnosed with acute promyelocytic leukemia.I am under 16 with a Lansky score above 50% or 16 and older with a Karnofsky score above 50%.I am under 18 for part 1a, and under 30 for parts 1b, 2, and 3.My organs are functioning well.I have previously been treated with venetoclax.I have not had MIBG therapy in the last 6 weeks.I have not had radiotherapy in the last 3 weeks.I haven't taken immunosuppressants for graft-versus-host disease in the last 2 weeks.I've had a stem cell transplant within the last 100 days.I have been treated with a MDM2 antagonist before.I do not have any infections that are uncontrolled or pose a risk.I haven't had cancer treatment in the last 28 days or 5 half-lives, whichever is shorter.I haven't had any cancer treatments like monoclonal antibodies within the last 30 days.My brain metastases are causing symptoms and need more treatment to manage.My cancer (neuroblastoma, AML, or precursor-B ALL) has not responded to standard treatments.My cancer has returned or worsened despite treatment, and there's no other therapy that can improve my life quality.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation: Solid Tumors: Idasanutlin Single Agent
- Group 2: ALL: Idasanutlin + Venetoclax
- Group 3: Neuroblastoma: Idasanutlin + Cyclophosphamide + Topotecan
- Group 4: AML: Idasanutlin + Venetoclax
- Group 5: AML: Idasanutlin + Fludarabine + Cytarabine
- Group 6: Neuroblastoma: Idasanutlin + Venetoclax
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.
Has Idasanutlin been investigated in past research projects?
"At present, there are 1258 ongoing clinical trials investigating Idasanutlin. Of those studies, 224 have reached the final stage of their research. While Philadelphia is a hub for this treatment's development, 41731 locations across America and around the world offer these tests as well."
Answered by AI
What conditions are typically treated with Idasanutlin?
"Idasanutlin can be employed to address a range of malignancies including lung cancer, multiple sclerosis and myelocytic acute leukemia."
Answered by AI
What is the participant count for this clinical experiment?
"This medical trial necessitates the involvement of 183 patients that satisfy the criteria for inclusion. Those interested in taking part can apply at either Alberta Children's Hospital, located in Calgary, or Phoenix Children's Hospital, stationed in Arizona."
Answered by AI
Is the age threshold for enrollment in this experiment limited to those under fifty?
"This research project has specific criteria for entry, which limits the age of participants from newborn to 30 years old."
Answered by AI
Is enrollment currently open for this clinical investigation?
"That is correct. According to clinicaltrials.gov, this medical trial commenced on January 27th 2020 and most recently updated its information on November 19th 2022. The study desires 183 participants across 10 different sites."
Answered by AI
How many healthcare facilities are currently involved in this clinical experiment?
"10 clinical trial sites are actively enrolling participants, such as Alberta Children'S Hospital in Calgary, Phoenix Children's Hospital in Phoenix and Arkansas Children's Hospital Research Institute in Little Rock. Additionally, there are other 7 locations involved with the study."
Answered by AI
Who is eligible to participate in this clinical research?
"This clinical trial requires participants to be between 0 and 30 years old, with histologically confirmed neuroblastoma, AML or precursor-B ALL. Depending on the age of the participant additional criteria must also met including performance status (Karnofsky ≥50% for those over 16) and end organ function. For females of childbearing potential they must agree to remain abstinent, use contraception and refrain from donating eggs while males are required to do likewise as well as using a condom if their partner is pregnant or has a female partner of child bearing potential. Additionally patients participating in this study must have at least one evaluable radiological site"
Answered by AI
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