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Luspatercept for Myelodysplastic Syndrome

Q: Is this clinical research experiment open to enrollment at the present time?

<p>Clinicaltrials.gov states that this specific clinical trial, which was originally published on April 30th 2024 and last updated October 27th 2023 has unfortunately ceased recruitment for the time being. However, there are 1,709 other active trials looking for volunteers at present.</p>

Phase < 1

Recruiting

Led By Guillermo Garcia-Manero, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Cohorts #1 and #2: Diagnosis of MDS according to WHO 2023 criteria and with low or int-1 risk by IPSS or a score of ≤ 3.5 by IPSS-R

Cohort #2: Patient defined as transfusion dependent by documentation of receiving at least 2 units of packed red blood cells (PRBCs) for a hemoglobin of less than 8.0 g/dL during an 8-week period prior to study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average 1 year.

Awards & highlights

Study Summary

This trial will test if luspatercept can reduce the need for blood transfusions in people with LR-MDS.

Who is the study for?

Adults diagnosed with low-risk Myelodysplastic Syndromes (MDS) who need fewer blood transfusions. Cohort #1 includes those not needing transfusions for a hemoglobin level under 8.0 g/dL in the past 8 weeks, while Cohort #2 includes those dependent on at least two units of red blood cells within the same period. Participants must have adequate liver and kidney function, an ECOG performance status of ≤2, and agree to use contraception if they can have children.Check my eligibility

What is being tested?

The study is testing Luspatercept's effectiveness in reducing the need for blood transfusions in patients with lower risk MDS. It's an open-label pilot trial where all participants receive Luspatercept; there are no comparison groups or placebos involved.See study design

What are the potential side effects?

While specific side effects for Luspatercept aren't listed here, similar medications often cause fatigue, muscle pain, dizziness, high blood pressure, and potential allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with MDS and my risk level is low to intermediate-1.

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I needed at least 2 blood transfusions due to low hemoglobin in the last 8 weeks.

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My liver functions are within the required range.

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My kidneys work well enough (creatinine clearance ≥40mL/min), and I don't have end-stage kidney disease.

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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average 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

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Side effects data

From 2021 Phase 3 trial • 336 Patients • NCT02604433

42%

Upper respiratory tract infection

35%

Headache

32%

Back pain

23%

Arthralgia

22%

Bone pain

22%

Cough

21%

Pyrexia

18%

Oropharyngeal pain

18%

Diarrhoea

17%

Fatigue

16%

Pharyngitis

15%

Pain in extremity

13%

Vomiting

13%

Nausea

13%

Abdominal pain

13%

Dizziness

13%

Myalgia

12%

Asthenia

11%

Abdominal pain upper

11%

Influenza

10%

Hypertension

Dyspepsia

Influenza like illness

Musculoskeletal pain

Nasal congestion

Urticaria

Gastroenteritis

Nasopharyngitis

Toothache

Tonsillitis

Hyperuricaemia

Pain

Urinary tract infection

Viral upper respiratory tract infection

Neck pain

Osteoporosis

Spinal pain

Lethargy

Injection site pain

Menstruation irregular

Alanine aminotransferase increased

Constipation

Transfusion reaction

Liver iron concentration increased

Musculoskeletal chest pain

Fall

Anaemia

Deep vein thrombosis

Extramedullary haemopoiesis

Septic shock

Transient ischaemic attack

Cerebrovascular accident

Cholangitis

Cholecystitis acute

Cellulitis

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Luspatercept + BSC

Placebo + BSC

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

Participants with lower risk MDS that are transfusion dependent (TD). Participants will be asked to come to the study clinic weekly for the first 3 weeks and then 1 time every 3 weeks after that to have tests and procedures (such as physical exams and blood draws). Luspatercept will be administered once every 3 weeks.

Group II: Cohort 1Experimental Treatment1 Intervention

Participants with lower risk MDS patients who have symptomatic anemia that are transfusion independent (TI). Participants will be asked to come to the study clinic weekly for the first 3 weeks and then 1 time every 3 weeks after that to have tests and procedures (such as physical exams and blood draws). Luspatercept will be administered once every 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Luspatercept

2018

Completed Phase 3

~1050

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,434 Total Patients Enrolled

Guillermo Garcia-Manero, M DPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

Is this clinical research experiment open to enrollment at the present time?

"Clinicaltrials.gov states that this specific clinical trial, which was originally published on April 30th 2024 and last updated October 27th 2023 has unfortunately ceased recruitment for the time being. However, there are 1,709 other active trials looking for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)

2024. "A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06113302.