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DFV890 for Myeloid Diseases

Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 months
Awards & highlights

Study Summary

This trial assesses safety, tolerability, and efficacy of a drug for MDS and LR CMML, to find a recommended dose.

Who is the study for?
Adults over 18 with certain low-risk myeloid diseases (like MDS or CMML) who haven't responded well to other treatments can join. They must be able to have bone marrow tests and have a performance status indicating they can still do daily activities. People who've had recent cancer treatments, are sensitive to DFV890 or similar drugs, or take certain other medications cannot participate.Check my eligibility
What is being tested?
The trial is testing DFV890's safety and effectiveness for myeloid diseases in two parts: one part tries different doses to find the best one, and the second part gives that dose to more people. It looks at how the drug works in the body and its impact on disease symptoms.See study design
What are the potential side effects?
Possible side effects of DFV890 aren't listed here but generally could include reactions related to immune system activation, issues from bone marrow biopsies, and interactions with existing conditions or medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 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
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence of Dose-limiting Toxicities (DLTs)
Incidence of dose interruptions, discontinuations and reductions
Secondary outcome measures
Area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of DFV890
Best overall response (BOR) per 2006 IWG criteria for MDS and CMML
Change from baseline in Absolute Neutrophil Count/White Blood Cells (ANC/WBC)
+13 more

Side effects data

From 2020 Phase 2 trial • 143 Patients • NCT04382053
7%
Anaemia
6%
Respiratory failure
6%
Diabetes mellitus
6%
Hyperglycaemia
3%
COVID-19 pneumonia
1%
Pulmonary embolism
1%
Sepsis
1%
Shock haemorrhagic
1%
Polyneuropathy
1%
Renal failure
1%
Dyspnoea
1%
Multiple organ dysfunction syndrome
1%
Condition aggravated
1%
Septic shock
1%
Pneumonia
1%
Amylase increased
1%
Peripheral artery thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DFV890 + SoC
Total
Standard of Care (SoC)

Trial Design

2Treatment groups
Experimental Treatment
Group I: DFV890 low doseExperimental Treatment1 Intervention
DFV890 given as single agent at a low dose
Group II: DFV890 high doseExperimental Treatment1 Intervention
DFV890 given as single agent at a high dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DFV890
2021
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,164 Total Patients Enrolled

Media Library

DFV890 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05552469 — Phase 1
Myeloid Diseases Research Study Groups: DFV890 high dose, DFV890 low dose
Myeloid Diseases Clinical Trial 2023: DFV890 Highlights & Side Effects. Trial Name: NCT05552469 — Phase 1
DFV890 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05552469 — Phase 1

Frequently Asked Questions

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

Is there any availability for new participants in this experiment?

"The information available on clinicaltrials.gov indicates that this medical study is actively seeking participants. It was initially posted on May 8th 2023 and its details were last modified a few weeks later, on May 29th 2023."

Answered by AI

Are there a plentiful number of hospitals in the state conducting this clinical trial?

"Currently, this medical trial is recruiting participants from 4 distinct sites. These include Houston, Hong Kong, Singapore and another four locations. It could be beneficial to choose the closest location for you in order to avoid extensive travelling should you decide to join."

Answered by AI

What is the maximum number of participants allowed in this clinical experiment?

"Indeed, a quick glance at clinicaltrials.gov shows that this medical trial is currently recruiting patients. It was first posted on May 8th 2023 and the most recent update came out on May 29th of the same year. The researchers are searching for 80 participants to be split between 4 different sites."

Answered by AI

Could you elucidate the potential harm caused by DFV890 in low doses?

"With limited clinical evidence for safety and efficacy, DFV890 low dose scored a 1 on Power's scale from 1 to 3."

Answered by AI

What is the ultimate goal of this investigation?

"This trial's primary outcome, assessed over a 13 month time period, is the rate of Dose-limiting Toxicities (DLTs). Secondary objectives include Progression free survival (PFS) measured through 2006 IWG criteria per local investigator review; Time to progression (TTP) determined by date of first documented CR or PR and date of first documented progression/relapse or death due to any cause; Change from baseline in Absolute Neutrophil Count/White Blood Cells (ANC/WBC), which will compare ratio ANC/WBC at study entry point."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
2023. "Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05552469.
~53 spots leftby Jun 2026
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