← Back to Search

Other

JNJ-74856665 for AML and MDS (DHODH Trial)

Q: What results are expected from this clinical trial?

<p>According to Janssen Research &#x26; Development, LLC - the primary sponsor of this trial - safety and tolerability will be evaluated through an assessment of Adverse Events (AEs). Additionally, secondary outcomes including Time-to-Response (TTR), Clinical Response in <a href="https://www.withpower.com/clinical-trials/mds">MDS</a> patients, and Duration of Response (DOR) will also be assessed at intervals that extend up to 6 months after last dose.</p>

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

A diagnosis of: Arms A and C: Acute Myeloid Leukemia (AML) according to the World Health Organization (WHO) 2016 criteria with relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options; or newly transformed secondary AML according to the WHO 2016 criteria and have exhausted standard therapeutic options for AML during their treatment prior to transformation; or high-risk or very high-risk Myelodysplastic Syndrome (MDS) according to the WHO 2016 criteria and the revised International Prognostic Scoring System (IPSS-R) with relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options; or Arm A only: chronic myelomonocytic leukemia-2 (CMML-2) according to the WHO 2016 criteria with relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options; Arm B: Eligible participants must be considered unsuitable for intensive treatment with a curative intent (including stem cell transplantation), but eligible to receive Azacitidine (AZA) treatment with the following underlying diseases: AML (newly diagnosed or relapsed/refractory) according to the 2016 WHO classification only if Venetoclax (VEN) + hypomethylating agent (HMA) (or low-dose cytarabine) is not indicated or available; or high-risk or very high-risk MDS according to the 2016 WHO classification and IPSS-R; or CMML-2 according to the WHO 2016 criteria; Arm D: Very low, low, or intermediate-risk MDS according to the 2016 WHO classification and IPSS-R and the following: Transfusion dependence defined as requiring at least 3 red blood cell (RBC) units transfused within 16 weeks prior to C1D1; pre-transfusion hemoglobin (Hb) should be less than (<) 9.0 grams per decilitre (g/dL) to count towards the 3 units total, Relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment or endogenous serum erythropoietin (EPO) level greater than (>) 500 milliunits per milliliter (mU/mL). Exception: Del(5q) karyotype is allowed, provided prior treatment with lenalidomide has failed or participant was ineligible to receive lenalidomide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years and 10 months

Awards & highlights

DHODH Trial Summary

This trial is testing a new drug to see if it is safe and effective when used alone or with other drugs.

Who is the study for?

This trial is for adults with certain blood disorders like AML or MDS who've tried other treatments without success, or can't use them. It's also for those unsuitable for intensive treatment but can take AZA, and some with lower-risk MDS needing regular blood transfusions. Participants must be in good physical condition and women/men agree to contraception.Check my eligibility

What is being tested?

The study tests JNJ-74856665 alone or combined with AZA (Azacitidine) or VEN (Venetoclax), aiming to find the safest doses. The focus is on how well patients tolerate these drugs and what effects they have on their diseases.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system, digestive issues, fatigue, changes in blood counts which could increase infection risk, and potential organ inflammation. Specific side effects will depend on individual patient responses.

DHODH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

You have been diagnosed with certain types of blood cancers or disorders and have exhausted or are not eligible for standard treatment options. This includes acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia-2 (CMML-2). In some cases, you may be eligible if you are not suitable for intensive treatment or stem cell transplantation.

DHODH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years and 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years and 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years and 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Arms A and D: Number of Participants with Dose-Limiting Toxicity (DLT)

Arms A, B, C and D: Number of Participants with AEs by Severity

Arms A, B, C and D: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

+1 more

Secondary outcome measures

Arm A, Arm B and Arm C: Clinical Response of all Participants with a Primary Disease of Acute Myeloid Leukemia (AML)

Muscular Dystrophy

Arm A, Arm B and Arm C: Clinical Response of all Participants with a Primary Disease of chronic myelomonocytic leukemia-2 (CMML-2)

+7 more

DHODH Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D: JNJ-74856665Experimental Treatment1 Intervention

Participants will receive JNJ-74856665 orally in a 21-day cycle. Participants with transfusion dependent relapsed/refractory Myelodysplastic Syndrome (MDS) will be included.

Group II: Arm C: JNJ-74856665 + Venetoclax (VEN)Experimental Treatment2 Interventions

Participants will receive JNJ-74856665 orally in combination with VEN in a 28-day cycle.

Group III: Arm B: JNJ-74856665 + Azacitidine (AZA)Experimental Treatment2 Interventions

Participants will receive JNJ-74856665 orally in combination with AZA administered intravenously (IV) or subcutaneously (SC) in a 28-day cycle.

Group IV: Arm A: JNJ-74856665Experimental Treatment1 Intervention

Participants will receive JNJ-74856665 orally in a 21-day cycle. The dose levels will be escalated based on the decisions of the Study Evaluation Team (SET) until a recommended Phase 2 dose (RP2D) has been identified.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZA

2016

Completed Phase 3

~180

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,155 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,752 Total Patients Enrolled

Media Library

AZA (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04609826 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Arm C: JNJ-74856665 + Venetoclax (VEN), Arm D: JNJ-74856665, Arm A: JNJ-74856665, Arm B: JNJ-74856665 + Azacitidine (AZA)

Acute Myeloid Leukemia Clinical Trial 2023: AZA Highlights & Side Effects. Trial Name: NCT04609826 — Phase 1

AZA (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04609826 — Phase 1

Frequently Asked Questions

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

To what extent is JNJ-74856665 hazardous to patients?

"Our team at Power have given JNJ-74856665 a rating of 1 on the safety scale because this is an early phase trial. As such, there is only limited proof that it is safe and effective."

Answered by AI

What results are expected from this clinical trial?

"According to Janssen Research & Development, LLC - the primary sponsor of this trial - safety and tolerability will be evaluated through an assessment of Adverse Events (AEs). Additionally, secondary outcomes including Time-to-Response (TTR), Clinical Response in MDS patients, and Duration of Response (DOR) will also be assessed at intervals that extend up to 6 months after last dose."

Answered by AI

Are there currently any openings to join this clinical experiment?

"As provided on clinicaltrials.gov, this medical study has ceased to seek additional candidates as of November 3rd 2022. Initially posted on the 26th of November 2020, it is no longer enrolling patients; however there are numerous other trials in progress now with 2804 recruiting subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-74856665 in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

2020. "A Study of JNJ-74856665 in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04609826.

All > Mds > Myelodysplastic Syndrome