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Chemotherapy

Venetoclax Combination Therapy for Leukemia

Q: Are octogenarians acceptable candidates for this experimentation?

The age parameters for inclusion in this study are between 18 years old and 54 years old.

Q: Has Venetoclax been tested before in a controlled experiment?

A total of 1585 clinical trials, with 325 in the last phase, are active for Venetoclax. Changsha, Hunan is a major hub conducting these experiments; yet there are 54168 other locations running related studies as well.

Q: How many individuals are enrolled in this clinical experiment?

Affirmative. Per the clinicaltrials.gov website, this research endeavour is currently seeking participants; it was first published on March 17th 2022 and its most recent update occurred on July 26th 2022. This investigation requires 6 individuals to be enrolled from a single healthcare site.

Q: What potential adverse effects might those taking Venetoclax be at risk of experiencing?

The safety of Venetoclax is appraised to be a 1 on the scale from 1 to 3 as this Phase 1 trial only has scant evidence backing up its efficacy and security.

Q: Am I eligible to register for this clinical trial?

This medical trial is accepting 6 applicants with a diagnosis of <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, aged between 18 and 54 years old.

Q: What is the ultimate outcome desired from this medical experiment?

The primary outcome of this trial, which will be measured during the 4-week cycle 1, is the incidence of adverse events. Secondary objectives include measuring composite complete response (CR), minimal residual disease (MRD) negativity after induction and consolidation for Philadelphia (Ph)-like <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a> (<a href="https://www.withpower.com/clinical-trials/all">ALL</a>). These endpoints are estimated with 95% Clopper Pearson binomial confidence intervals.

Q: Is this investigation currently accepting participants?

Affirmative. According to clinicaltrials.gov, this medical research is currently recruiting patients; it was initially made available on March 17th 2022 and a recent revision occurred during July 26th 2022. They are looking for 6 individuals at 1 location.

Q: What ailments is Venetoclax routinely employed to address?

Venetoclax has been clinically verified as a viable treatment for pheochromocytomas, <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>, and varicella-zoster virus acute retinal necrosis.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My recent diagnosis shows more than 5% immature blood cells in my bone marrow.

Select...

I can perform all self-care but may not be able to work.

Select...

My leukemia is confirmed to be B-cell ALL.

Select...

I am between 18 and 54 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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%

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%

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

Methotrexate

2013

Completed Phase 4

~3800

Cyclophosphamide

1995

Completed Phase 3

~3770

Cytarabine

2016

Completed Phase 3

~3310

Mercaptopurine

2012

Completed Phase 4

~12330

Prednisone

2014

Completed Phase 4

~2370

Vincristine Sulfate

2005

Completed Phase 3

~10150

Venetoclax

2019

Completed Phase 3

~1990

Daunorubicin Hydrochloride

2011

Completed Phase 3

~5070

Pegaspargase

2005

Completed Phase 3

~9010

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,654 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,126 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

Frequently Asked Questions

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

Are octogenarians acceptable candidates for this experimentation?

"The age parameters for inclusion in this study are between 18 years old and 54 years old."

Answered by AI

Has Venetoclax been tested before in a controlled experiment?

"A total of 1585 clinical trials, with 325 in the last phase, are active for Venetoclax. Changsha, Hunan is a major hub conducting these experiments; yet there are 54168 other locations running related studies as well."

Answered by AI

How many individuals are enrolled in this clinical experiment?

"Affirmative. Per the clinicaltrials.gov website, this research endeavour is currently seeking participants; it was first published on March 17th 2022 and its most recent update occurred on July 26th 2022. This investigation requires 6 individuals to be enrolled from a single healthcare site."

Answered by AI

What potential adverse effects might those taking Venetoclax be at risk of experiencing?

"The safety of Venetoclax is appraised to be a 1 on the scale from 1 to 3 as this Phase 1 trial only has scant evidence backing up its efficacy and security."

Answered by AI

Am I eligible to register for this clinical trial?

"This medical trial is accepting 6 applicants with a diagnosis of leukemia, aged between 18 and 54 years old."

Answered by AI

What is the ultimate outcome desired from this medical experiment?

"The primary outcome of this trial, which will be measured during the 4-week cycle 1, is the incidence of adverse events. Secondary objectives include measuring composite complete response (CR), minimal residual disease (MRD) negativity after induction and consolidation for Philadelphia (Ph)-like acute lymphoblastic leukemia (ALL). These endpoints are estimated with 95% Clopper Pearson binomial confidence intervals."

Answered by AI

Is this investigation currently accepting participants?

"Affirmative. According to clinicaltrials.gov, this medical research is currently recruiting patients; it was initially made available on March 17th 2022 and a recent revision occurred during July 26th 2022. They are looking for 6 individuals at 1 location."

Answered by AI

What ailments is Venetoclax routinely employed to address?

"Venetoclax has been clinically verified as a viable treatment for pheochromocytomas, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia

2022. "Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05157971.

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