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Nucleoside Analog

Venetoclax Combination Therapy for Blood Cancers

Phase 1
Recruiting
Led By Andrew E Place, MD, PhD
Research Sponsored by Andrew E. Place
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lansky/Karnofsky performance status ≥ 50%
Age ≥ 1 and ≤ 21 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug, venetoclax, to see if it is safe and effective when used with other cancer drugs to treat pediatric and young adult patients with blood cancers including myelodysplastic syndrome (MDS), acute myeloid leukemia derived from myelodysplastic syndrome (MDS/AML), and acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL).

Who is the study for?
This trial is for pediatric and young adult patients up to 40 years old with high-risk blood cancers like MDS, AML from MDS, or ALL/LBL. They should have recovered from previous treatments, not have severe organ damage or active infections, and can't be pregnant or breastfeeding. Participants must agree to use effective contraception.Check my eligibility
What is being tested?
The trial tests the safety of venetoclax combined with chemotherapy drugs in treating various aggressive blood cancers. It aims to see how well patients tolerate this combination therapy and involves a range of medications tailored to specific disease cohorts.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems, liver issues shown by elevated enzymes in blood tests, allergic reactions to medication components, heart problems detectable on echocardiograms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most activities but need help with some.
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I am between 1 and 21 years old.
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I have T-ALL, T-LBL, or B-ALL that is relapsed or not responding to treatment.
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I am 40 years old or younger.
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I am between 18 and 40 years old.
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I have MDS, AML from MDS, or therapy-related myeloid neoplasm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Grade 2 or Higher Treatment-Related Toxicity
Incidence of calaspargase pegol related toxicities
Maximum tolerated dose (MTD)
+1 more
Secondary outcome measures
2-year Event free survival (EFS)
2-year Overall Survival (OS)
Complete Remission (CR) Rate
+3 more
Other outcome measures
Percentage of patients to proceed to Hematopoietic Stem Cell Transplant (HSCT)
Proportion of patients to receive all doses of venetoclax

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Hypokalaemia
11%
Neutrophil count decreased
11%
Pneumonia
11%
Sepsis
11%
Anaemia
11%
Blood creatinine increased
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Dermatitis
11%
Electrocardiogram QT prolonged
11%
Abdominal pain
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

3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment11 Interventions
Patients with relapsed/refractory acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LBL) or acute leuekmai of ambiguous lineage. It is expected that up to 18 people will participate in Part 1 (Dose Determination) and an additional 12 people will participate in Part 2 (Dose Expansion) of this cohort. Cohort C: Treatment cycle is approximately 32 days for one cycle and will be a single treatment cycle: Dosage, duration and timings as outlined in protocol. Venetoclax Dexamethasone Vincristine Doxorubicin Dexrazoxane Calaspargase pegol ---Short acting Erwinia preparations (recombinant or native Erwinia asparaginase) may be used for participants with known pegaspargase or calaspargase pegol allergy Cytarabine Methotrexate Hydrocortisone Leucovorin- *Cytarabine, Methotrexate, Hydrocortisone and Leucovorin may be given more frequently if leukemia/lymphoma cells are detected in spinal fluid),
Group II: Cohort BExperimental Treatment6 Interventions
Patients with myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) with an underlying genetic condition that increases their risk for developing treatment-related toxicities. It is expected that up to 18 people will participate in Part 1 (Dose Determination) and an additional 6 people will participate in Part 2 (Dose Expansion) of this cohort. Venetoclax-once daily on predetermined days per protocol Azacitidine-once daily on predetermined days per protocol Cytarabine, Methotrexate, Hydrocortisone and Leucovorin will be given only if MDS/leukemia cells are detected in spinal fluid per determination of treating physician
Group III: Cohort AExperimental Treatment6 Interventions
For Part 1, participants will receive: Patients with myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML). It is expected that up to 18 people will participate in Part 1 (Dose Determination) and an additional 14-20 people will participate in Part 2 (Dose Expansion) of this cohort Treatment cycle is approximately 28 days for up to 4 cycles Venetoclax-once daily on predetermined days per protocol Azacitidine-once daily on predetermined days per protocol Cytarabine, Methotrexate, Hydrocortisone and Leucovorin will be given only if MDS/leukemia cells are detected in spinal fluid per determination of treating physician
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Dexamethasone
2007
Completed Phase 4
~2590
Dexrazoxane
2016
Completed Phase 2
~80
Doxorubicin
2012
Completed Phase 3
~7940
Leucovorin
2005
Completed Phase 4
~5730
Erwinia asparaginase
2012
Completed Phase 2
~30
Hydrocortisone
2005
Completed Phase 4
~1280
Cytarabine
2016
Completed Phase 3
~3310
Methotrexate
2013
Completed Phase 4
~3800
Azacitidine
2012
Completed Phase 3
~1440
Vincristine
2003
Completed Phase 4
~2910

Find a Location

Who is running the clinical trial?

Andrew E. PlaceLead Sponsor
AbbVieIndustry Sponsor
967 Previous Clinical Trials
503,464 Total Patients Enrolled
ServierIndustry Sponsor
49 Previous Clinical Trials
43,366 Total Patients Enrolled

Media Library

Azacitidine (Nucleoside Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05292664 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Cohort A, Cohort B, Cohort C
Acute Lymphoblastic Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT05292664 — Phase 1
Azacitidine (Nucleoside Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05292664 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial limited to individuals aged 65 and above?

"As specified in the study requirements, potential participants must be between 1 year and 40 years old."

Answered by AI

What aims is this research attempting to achieve?

"The primary goal of this investigation, monitored over a period of up to 30 days post-treatment, is measuring the incidence of calaspargase pegol related toxicities. Secondary outcomes include Overall Response Rate (ORR), two year Overall Survival (OS) and two year Event Free Survival (EFS). The ORR will be determined by determining how many patients achieved complete remission (CR), partial response, CR with incomplete platelet recovery or CR with incomplete count recovery. OS is calculated using the Kaplan-Meier method as time from study entry until death or last known alive date while EFS tracks progressions to leukemia, relapse after"

Answered by AI

What are the requirements for accepting participants in this research endeavor?

"This investigation is recruiting 92 participants aged between one and forty years old who are presently diagnosed with acute lymphocytic leukemia (L1). It's mandatory for applicants to fulfil the following prerequisites: MDS with blasts under 10% possessing high-risk features, those refractory to initial treatment of MDS, relapsed cases of MDS/AML (may be new or have previously been treated), therapy related myeloid neoplasms (tMDS/AML; could either be starting off or at a relapse/refractory stage); note that these may come from hereditary predisposition as long as it does not"

Answered by AI

Are any slots still available for this clinical trial?

"Affirmative. According to the particulars found on clinicaltrials.gov, this investigation is currently enrolling participants who meet its requirements. The research began recruitment in December 1st 2022 and was last edited on November 28th 2022 with a goal of enlisting 92 patients from one location."

Answered by AI

What is the aggregate number of individuals taking part in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this investigation is actively searching for participants and opened recruitment on December 1st 2022 with its most recent update occurring at November 28th 2022. 92 individuals are needed across a single medical centre."

Answered by AI

How secure is the application of Venetoclax in a therapeutic setting?

"Limited safety and efficacy data of Venetoclax suggests that it is relatively risky, earning a score 1 on our scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Venetoclax Basket Trial for High Risk Hematologic Malignancies
Andrew E. Place, MD 2023. "Venetoclax Basket Trial for High Risk Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05292664.
~38 spots leftby Apr 2025
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