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DNA Methyltransferase Inhibitor

venetoclax for Myelodysplastic Syndrome

Phase 1

Waitlist Available

Research Sponsored by AbbVie

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 measured from first dose of study drug to start of new non-protocol specified mds therapy, and for up to 5 years after the last subject is enrolled.

Awards & highlights

Study Summary

This trial is testing a new cancer drug, venetoclax, to see if it is safe and works well against relapsed or refractory myelodysplastic syndrome (MDS).

Eligible Conditions

Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured from the date of the first dose of study drug to date of earliest disease progression, death, or initiation of new non-protocol-specified anti-mds therapy without documented progression, and for up to 5 years after the last subject is enrolled.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured from the date of the first dose of study drug to date of earliest disease progression, death, or initiation of new non-protocol-specified anti-mds therapy without documented progression, and for up to 5 years after the last subject is enrolled.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from the date of the first dose of study drug to date of earliest disease progression, death, or initiation of new non-protocol-specified anti-mds therapy without documented progression, and for up to 5 years after the last subject is enrolled. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

AUC [0-24] for venetoclax

Azacitidine

AUCt for azacitidine

+9 more

Secondary outcome measures

Complete Remission (CR) Rate

Duration of Complete Response (CR)

Duration of ORR

+12 more

Side effects data

From 2024 Phase 2 trial • 323 Patients • NCT02910583

88%

DIARRHOEA

47%

ARTHRALGIA

44%

NEUTROPENIA

38%

NAUSEA

34%

UPPER RESPIRATORY TRACT INFECTION

31%

VOMITING

31%

THROMBOCYTOPENIA

31%

OROPHARYNGEAL PAIN

28%

PYREXIA

28%

BACK PAIN

25%

INCREASED TENDENCY TO BRUISE

25%

PETECHIAE

25%

HEADACHE

22%

DYSPEPSIA

22%

GASTROOESOPHAGEAL REFLUX DISEASE

22%

FATIGUE

22%

PAIN IN EXTREMITY

22%

PRURITUS

22%

HYPERTENSION

22%

MUSCLE SPASMS

19%

CONSTIPATION

19%

EPISTAXIS

19%

RASH

19%

SKIN ABRASION

19%

ABDOMINAL PAIN

19%

CONTUSION

19%

DIZZINESS

16%

ONYCHOCLASIS

16%

ABDOMINAL PAIN UPPER

16%

DRY SKIN

16%

ERYTHEMA

16%

PALPITATIONS

16%

NASOPHARYNGITIS

16%

RASH MACULO-PAPULAR

13%

HERPES ZOSTER

13%

SKIN LESION

13%

HYPERURICAEMIA

13%

VISION BLURRED

13%

CHILLS

13%

OEDEMA PERIPHERAL

13%

CELLULITIS

13%

COUGH

13%

SINUSITIS

13%

ANAEMIA

13%

MUSCULOSKELETAL CHEST PAIN

13%

BLOOD CREATININE INCREASED

13%

HAEMATURIA

HYPERKALAEMIA

ATRIAL FIBRILLATION

VERTIGO

FLATULENCE

MOUTH ULCERATION

RECTAL HAEMORRHAGE

STOMATITIS

ASTHENIA

WOUND HAEMORRHAGE

SYNCOPE

ALOPECIA

MYALGIA

URINARY TRACT INFECTION

NIGHT SWEATS

PARONYCHIA

ORAL HERPES

VIRAL INFECTION

ALANINE AMINOTRANSFERASE INCREASED

INSOMNIA

PNEUMONIA

VITAMIN B12 DEFICIENCY

PARAESTHESIA

SKIN ATROPHY

SINUS TACHYCARDIA

HAEMORRHOIDAL HAEMORRHAGE

TOOTHACHE

INJECTION SITE BRUISING

PAIN

PERIPHERAL SWELLING

RASH PUSTULAR

SKIN INFECTION

ARTHROPOD BITE

WHITE BLOOD CELL COUNT DECREASED

HYPOKALAEMIA

BONE PAIN

ANXIETY

DERMATITIS ACNEIFORM

ECCHYMOSIS

ECZEMA

SKIN FRAGILITY

ASPARTATE AMINOTRANSFERASE INCREASED

HYPOTHYROIDISM

ABDOMINAL DISCOMFORT

SEASONAL ALLERGY

CONJUNCTIVITIS

PHARYNGITIS

HYPOMAGNESAEMIA

NEUROPATHY PERIPHERAL

HYPERHIDROSIS

IRON DEFICIENCY

SPINAL PAIN

TESTICULAR SWELLING

SKIN FISSURES

DRY EYE

MUSCULOSKELETAL PAIN

RIB FRACTURE

PHLEBITIS

SCIATICA

RASH ERYTHEMATOUS

SCRATCH

BLOOD BILIRUBIN INCREASED

LOCALISED INFECTION

RETROPERITONEAL HAEMORRHAGE

SPONTANEOUS HAEMATOMA

MYELODYSPLASTIC SYNDROME

NASAL CONGESTION

RENAL CANCER

INFLUENZA

APHTHOUS ULCER

CHEST PAIN

BRONCHITIS

PLATELET COUNT DECREASED

DECREASED APPETITE

HYPOCALCAEMIA

HYPOAESTHESIA

NASAL DRYNESS

NAIL RIDGING

ERECTILE DYSFUNCTION

CARDIAC FAILURE

EYE HAEMORRHAGE

DRY MOUTH

NON-CARDIAC CHEST PAIN

RESPIRATORY TRACT INFECTION

TOOTH INFECTION

HYPOGLYCAEMIA

NECK PAIN

DEPRESSION

INFLUENZA LIKE ILLNESS

BASAL CELL CARCINOMA

CONGESTIVE CARDIOMYOPATHY

GASTROENTERITIS

ABDOMINAL ABSCESS

RHINITIS ALLERGIC

RHINITIS

100%

80%

60%

40%

20%

Study treatment Arm

MRD Cohort: uMRD Not Confirmed (IbrVen->IbrVen) Overall Study

MRD Cohort: uMRD Not Confirmed (IbrVen->Ibr) Pre-Randomization

MRD Cohort: All Participants Overall Study

MRD Cohort: Confirmed uMRD (IbrVen->Ibr) Overall Study

MRD Cohort: uMRD Not Confirmed (IbrVen->Ibr) Overall Study

MRD Cohort: uMRD Not Confirmed (IbrVen->IbrVen) Pre-Randomization

MRD Cohort: Confirmed uMRD (IbrVen->Pbo) Pre-Randomization

MRD Cohort: Confirmed uMRD (IbrVen->Pbo) Overall Study

Fixed Duration Cohort: Overall Study

MRD Cohort: All Participants Pre-Randomization

MRD Cohort: Confirmed uMRD (IbrVen->Ibr) Pre-Randomization

Trial Design

3Treatment groups

Experimental Treatment

Group I: Venetoclax monotherapy (Cohort 1)Experimental Treatment1 Intervention

Group II: Venetoclax + azacitidine (Cohort 2)Experimental Treatment2 Interventions

Group III: Safety Expansion (Cohort 3)Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

venetoclax

2021

Completed Phase 2

~750

azacitidine

2005

Completed Phase 3

~1740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,320 Total Patients Enrolled

Celgene; Genentech, Inc.UNKNOWN

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

147,039 Total Patients Enrolled

Frequently Asked Questions

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

How widespread is access to this clinical trial?

"Fifteen separate medical centres are currently running this trial, such as the University of Arizona Cancer Center in Tucson (ID# 157503), Dana-Farber Cancer Institute in Boston (ID# 155361) and Columbia Univ Medical Center in New york City (ID# 156388). These three locations are among a total of fifteen."

Answered by AI

To what extent is subject participation in this medical experiment expanding?

"At this point, no more participants are being accepted for the study. It was initially listed on March 7th 2017 and last updated August 8th 2022. Fortunately there are 1,595 myelodysplastic syndromes studies recruiting patients as well as 340 trials actively searching for those interested in taking venetoclax."

Answered by AI

To what degree do patients risk harm when taking venetoclax?

"There is sparse clinical data confirming the safety of venetoclax, so it was given a score of 1."

Answered by AI

What health conditions have been treated with venetoclax?

"Venetoclax is used to treat induction chemotherapy and has been proven effective in treating certain refractory anemias, leukemias, myelocytic disorders, acute dysplasia as well as multilineage ones."

Answered by AI

Are there any other trials that have utilized venetoclax to make medical progress?

"Venetoclax research began at the Chinese University of Hong Kong-Prince of Wales Hospital in 2006 and, to date, there have been 208 trials completed. Currently, 340 studies are recruiting participants with many based in Tucson, Arizona."

Answered by AI

Are participants being accepted for this research project at the present time?

"Unfortunately, presently there are no openings in this trial. When first posted on March 7th 2017 and last updated on August 8 2022, the study had concluded its recruitment phase. As of now, 1595 trials related to myelodysplastic syndromes and 340 studies concerning venetoclax require participants."

Answered by AI

Recent research and studies

Clinical Lymphoma Myeloma and LeukemiaJournal

Allogeneic Stem-cell Transplantation in Patients with Myelodysplastic Syndromes and Prevention of Relapse

Franke, Georg-Nikolaus, Philipp Lückemeier, and Uwe Platzbecker. 2021. “Allogeneic Stem-cell Transplantation in Patients with Myelodysplastic Syndromes and Prevention of Relapse”. Clinical Lymphoma Myeloma and Leukemia. Elsevier BV. doi:10.1016/j.clml.2020.10.008.

clinicaltrials.govStudy

A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)

2017. "A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02966782.