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B-cell lymphoma-2 (BCL-2) inhibitor
Venetoclax + Chemotherapy for Acute Myeloid Leukemia
Phase 3
Recruiting
Led By Seth Karol, MD
Research Sponsored by LLS PedAL Initiative, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment.
-- Normal serum creatinine based on age/sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing if adding venetoclax to standard chemotherapy can improve survival in young patients with AML who have relapsed and cannot receive additional anthracyclines.
Who is the study for?
This trial is for children and young adults aged up to 21 with relapsed Acute Myeloid Leukemia (AML) who can't receive more anthracyclines or are in their second relapse. They should be generally fit, have recovered from previous cancer treatments, not have certain conditions like Down syndrome or active infections, and must not be on medications that could interfere with the study drugs.Check my eligibility
What is being tested?
The trial tests if adding venetoclax to a chemo mix of fludarabine/cytarabine/gemtuzumab ozogamicin improves survival in young AML patients at first or second relapse. It's randomized, meaning participants are put into groups by chance to compare different treatment combinations.See study design
What are the potential side effects?
Possible side effects include low blood counts leading to increased infection risk, bleeding problems, liver issues due to drug interactions, allergic reactions to medication components, and potential heart complications. The severity of side effects can vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
It has been over 21 days since I last received interleukins, interferons, or cytokines treatment.
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My kidney function tests are normal for my age and sex.
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It's been over 42 days since I had any cell therapy, like T cell or NK cell treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I am not currently on medications like cyclosporine or tacrolimus for post-transplant care.
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It's been over 14 days since my last long-acting growth factor dose or over 7 days for a short-acting one.
Select...
It has been more than 42 days since my last major bone marrow radiation.
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I am fit enough for another intensive chemotherapy as this is my second relapse.
Select...
I have never needed treatment for heart failure.
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My leukemia does not have the FLT3/ITD mutation.
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I am between 29 days and 21 years old.
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I do not have active symptoms of graft versus host disease.
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I have never had severe liver blockage diseases or leukemia with CD33 negative cells.
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I can take care of myself but might not be able to do heavy physical work.
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I have been treated with venetoclax before.
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I do not have heart failure symptoms at my cancer's return.
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
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Area Under the Plasma Concentration-time Curve Over a 24-hour Dose Interval (AUC0-24)
Cumulative Incidence of Relapse (CIR)
Duration of Response (DOR)
+10 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Dermatitis
11%
Hypokalaemia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Experimental Arm with VenetoclaxExperimental Treatment5 Interventions
During cycle 1 (each cycle is 42 days), participants will receive 300 mg adult dose equivalent of venetoclax once on Day 1 followed by 600 mg adult dose equivalent of venetoclax on Days 2-21. Participants will also receive 30 mg/m^2 of fludarabine followed by 2 g/m^2 of cytarabine on Days 8-12. Gemtuzumab 3 mg/m^2 will be given on Day 13 (only for participants with CD33 expression on leukemia blasts).
During cycle 2, participants will receive 600 mg adult dose equivalent of venetoclax on Days 1-21. Participants will receive 30 mg/m^2 of fludarabine followed by 2 g/m^2 of cytarabine on Days 1-5.
After cycle 2 participants are assessed for HSCT or azacitidine maintenance therapy in combination with venetoclax.
Group II: Arm A: Control Arm without VenetoclaxActive Control4 Interventions
During cycle 1 (each cycle is 42 days), participants will receive 30 mg/m^2 of fludarabine followed by 2 g/m^2 of cytarabine on Days 1-5. Gemtuzumab 3 mg/m^2 will be given on Day 6 (only for participants with CD33 expression on leukemia blasts).
During cycle 2 participants will receive 30 mg/m^2 of fludarabine followed by 2 g/m^2 of cytarabine on Days 1-5.
After cycle 2 participants are assessed for hematopoietic stem cell transplantation (HSCT) or azacitidine maintenance therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Fludarabine
2012
Completed Phase 3
~1100
Venetoclax
2019
Completed Phase 3
~1990
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
EuPALUNKNOWN
Roche-GenentechIndustry Sponsor
24 Previous Clinical Trials
3,587 Total Patients Enrolled
Princess Maxima Center for Pediatric Oncology (European Sponsor)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stem cell infusion before starting the treatment.It has been over 21 days since I last received interleukins, interferons, or cytokines treatment.I do not have HIV.My kidney function tests are normal for my age and sex.It's been over 42 days since I had any cell therapy, like T cell or NK cell treatment.My organs are working well.I am taking other medications.My kidney function is normal.I am eligible for the study but won't receive gemtuzumab ozogamicin treatment.It's been over 21 days since my last antibody-drug treatment, and any side effects are mild.I can take care of myself but might not be able to do heavy physical work.I haven't had chemotherapy in the last 14 days, except for certain allowed medications.I agree to use a condom and not father a child or donate sperm during and for 4 months after the study.I have not started radiation therapy yet.It's been over 2 weeks since my small area radiation therapy for symptom relief.My first cancer recurrence and I can't handle more strong chemotherapy.I am not currently on medications like cyclosporine or tacrolimus for post-transplant care.It's been over 14 days since my last long-acting growth factor dose or over 7 days for a short-acting one.My leukemia does not show CD33 on tests.It has been more than 42 days since my last major bone marrow radiation.I am fit enough for another intensive chemotherapy as this is my second relapse.I have never needed treatment for heart failure.It has been over 84 days since my bone marrow or stem cell transplant.My heart is functioning well.I should not receive gemtuzumab ozogamicin.I have never had a severe case of VOD/SOS.My leukemia does not have the FLT3/ITD mutation.I am between 29 days and 21 years old.I have recovered from side effects of my previous cancer treatments.It has been over 84 days since my last major radiation therapy.I do not have an active, uncontrolled infection.I do not have active symptoms of graft versus host disease.I am eligible for a specific medication infusion.My liver is working well.I am a woman who has started menstruating and I have a positive pregnancy test.I have never had severe liver blockage diseases or leukemia with CD33 negative cells.I cannot take medications by mouth due to a digestive condition.I am a young person with a specific type of leukemia without a certain mutation, facing my second or first relapse and can/cannot undergo intense chemotherapy.I have been diagnosed with APL or JMML.My cancer has spread to my brain but is limited or causing symptoms.I have a known congenital bone marrow failure syndrome.I haven't taken strong medications like rifampin or St. John's wort in the last week.I have had a severe liver condition after a transplant.I can take care of myself but might not be able to do heavy physical work.I have received spinal injections of cancer drugs with no waiting period needed.I have been treated with venetoclax before.My liver enzyme (ALT) levels are within the normal range, or high due to leukemia in my liver.I do not have heart failure symptoms at my cancer's return.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Control Arm without Venetoclax
- Group 2: Arm B: Experimental Arm with Venetoclax
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there long-term risks associated with Venetoclax?
"Venetoclax has been shown to be safe in multiple clinical trials, so it received a score of 3."
Answered by AI
How many individuals are included in this experiment?
"That is correct. The clinical trial, which was originally posted on October 1st, 2020, is still recruiting patients. So far, they have one location and 98 participants."
Answered by AI
Is there still space for individuals in this clinical trial?
"The trial is still open for recruitment and this can be seen by the most recent edit date on clinicaltrials.gov. The study was first posted on October 1st, 2022."
Answered by AI
Are octogenarians welcome in this experiment?
"The minimum age requirement for this trial is 29 days, with the maximum age being capped at 21 years old."
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To whom does this trial grant access?
"This study is meant for individuals aged 29 days to 21 years old that have been diagnosed with leukemia. Out of the 98 total spots, a few are still available for eligible patients."
Answered by AI
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