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Chemotherapy

Venetoclax Combination Therapy for Leukemia

Phase 1
Recruiting
Led By Ibrahim T Aldoss
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed disease with >= 5% blasts in the marrow
Eastern Cooperative Oncology Group (ECOG) =< 2
Must not have
Other active malignancy
Live vaccines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Summary

This trial is testing a new combination of drugs to treat leukemia. The goal is to find out if it is safe and works well.

Who is the study for?
Adults aged 18-54 with newly diagnosed B-cell acute lymphoblastic leukemia (ALL) can join this trial. They must be in good physical condition, not pregnant or breastfeeding, and willing to use non-hormonal birth control. People with certain heart conditions, other cancers, uncontrolled infections or those who have taken strong medications that affect liver enzymes recently cannot participate.
What is being tested?
The trial is testing the safety and optimal dose of a drug called Venetoclax when added to a pediatric-inspired chemotherapy regimen (C10403). This combination targets cancer cell growth by blocking essential proteins and using various chemo drugs to kill or stop cancer cells from dividing.
What are the potential side effects?
Venetoclax combined with C10403 chemotherapy may cause side effects like low blood counts leading to increased infection risk, fatigue, nausea, liver issues, potential for allergic reactions and could affect heart function. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My recent diagnosis shows more than 5% immature blood cells in my bone marrow.
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I can perform all self-care but may not be able to work.
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My leukemia is confirmed to be B-cell ALL.
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I am between 18 and 54 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any other active cancer.
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I have not received any live vaccines recently.
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My leukemia has specific genetic changes.
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I need brain radiation due to cancer spread.
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I do not have any ongoing infections that aren't under control.
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I have not had a heart attack or unstable angina in the last 6 months.
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I do not have any uncontrolled serious illnesses.
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I have T-cell acute lymphoblastic leukemia.
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I am not pregnant or breastfeeding.
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I haven't taken strong or moderate drugs that affect liver enzymes in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity
Incidence of adverse events
Secondary outcome measures
Complete response (CR) after consolidation
Complete response (CR) after consolidation for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL)
Complete response (CR) after induction +/- extended induction
+9 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
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

1Treatment groups
Experimental Treatment
Group I: Treatment (venetoclax, C10403 regimen)Experimental Treatment9 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Mercaptopurine
2012
Completed Phase 4
~12330
Cyclophosphamide
1995
Completed Phase 3
~3770
Methotrexate
2013
Completed Phase 4
~3800
Pegaspargase
2005
Completed Phase 3
~9010
Prednisone
2014
Completed Phase 4
~2370
Venetoclax
2019
Completed Phase 3
~1990
Vincristine Sulfate
2005
Completed Phase 3
~10160
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5110

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
575 Previous Clinical Trials
1,922,700 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,395 Total Patients Enrolled
Ibrahim T AldossPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
13 Total Patients Enrolled

Media Library

C10403 (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05157971 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Treatment (venetoclax, C10403 regimen)
Acute Lymphoblastic Leukemia Clinical Trial 2023: C10403 Highlights & Side Effects. Trial Name: NCT05157971 — Phase 1
C10403 (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05157971 — Phase 1
~2 spots leftby Sep 2025
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