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Monoclonal Antibodies
Isatuximab for Immune Cytopenia After Stem Cell Transplant
Phase 2
Recruiting
Led By Michael Scorder, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 up to 4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to find out if isatuximab can help people with ICs after allo-HCT.
Who is the study for?
Adults who have immune cytopenias after a stem cell transplant and haven't improved after at least two treatments, including steroids and rituximab. They must be in remission from the disease that required the transplant, not pregnant or willing to use birth control, free of active hepatitis or HIV, and able to give consent.
What is being tested?
The trial is testing Isatuximab's effectiveness for patients with persistent immune cytopenias following an allogeneic hematopoietic cell transplant. It aims to see if this drug can help where other treatments like corticosteroids have failed.
What are the potential side effects?
Possible side effects of Isatuximab include allergic reactions, infusion-related reactions (like fever or chills), low blood counts which could increase infection risk, tiredness, nausea, and potential organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall response rate
Side effects data
From 2023 Phase 3 trial • 307 Patients • NCT0299033835%
Neutropenia
21%
Diarrhoea
21%
Fatigue
21%
Pneumonia
20%
Constipation
19%
Asthenia
19%
Upper Respiratory Tract Infection
16%
Back Pain
13%
Pyrexia
12%
Arthralgia
12%
Oedema Peripheral
11%
Bronchitis
11%
Thrombocytopenia
11%
Muscle Spasms
9%
Dyspnoea
9%
Insomnia
9%
Nausea
9%
Urinary Tract Infection
9%
Bone Pain
7%
Cough
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Cataract
7%
Pruritus
6%
Fall
6%
Headache
5%
Hypertension
5%
Disease Progression
5%
Decreased Appetite
5%
Tremor
5%
Muscular Weakness
5%
Musculoskeletal Chest Pain
5%
Rash
4%
Acute Kidney Injury
4%
Influenza
4%
Abdominal Pain
4%
Vomiting
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Pathological Fracture
3%
Oropharyngeal Pain
3%
Myalgia
3%
Pain In Extremity
3%
Septic Shock
3%
Dizziness
3%
Stomatitis
2%
Renal Failure
2%
Lower Respiratory Tract Infection
2%
Hypercalcaemia
2%
General Physical Health Deterioration
2%
Oral Herpes
2%
Productive Cough
2%
Lung Infection
1%
Pleural Effusion
1%
Haemorrhage Intracranial
1%
Infusion Related Reaction
1%
Pulmonary Embolism
1%
Renal Aneurysm
1%
Sudden Death
1%
Pneumonia Fungal
1%
Covid-19 Pneumonia
1%
Candida Pneumonia
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Cytomegalovirus Gastrointestinal Infection
1%
Gastroenteritis
1%
Tumour Associated Fever
1%
Syncope
1%
Dehydration
1%
Respiratory Tract Infection
1%
Basal Cell Carcinoma
1%
Anaemia
1%
Hyponatraemia
1%
Confusional State
1%
Malnutrition
1%
Cerebral Haemorrhage
1%
Angina Pectoris
1%
Cauda Equina Syndrome
1%
Ischaemic Stroke
1%
Atrial Fibrillation
1%
Cardiac Failure
1%
Orthostatic Hypotension
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Pancreatitis Acute
1%
Diabetic Ulcer
1%
Death
1%
Accidental Overdose
1%
Spinal Compression Fracture
1%
Weight Decreased
1%
Pneumonia Bacterial
1%
Pyelonephritis
1%
Pyelonephritis Acute
1%
Sepsis
1%
Sinusitis
1%
Hyperviscosity Syndrome
1%
Pancytopenia
1%
Femur Fracture
1%
Pneumonia Haemophilus
1%
Pneumonia Influenzal
1%
Pneumonia Streptococcal
1%
Bronchospasm
1%
Large Intestine Perforation
1%
Covid-19
1%
Infection
1%
Presyncope
1%
Spinal Subdural Haematoma
1%
Retinal Detachment
1%
Vision Blurred
1%
Myocardial Infarction
1%
Deep Vein Thrombosis
1%
Ataxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pd (Pomalidomide + Dexamethasone)
IPd (Isatuximab + Pomalidomide + Dexamethasone)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Refractory Immune CytopeniasExperimental Treatment1 Intervention
Participants will be adults who develop Immune Cytopenias/ICs after Allogeneic Hematopoietic Cell Transplantation/allo-HCT and who did not respond to initial immunosuppressive therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,971 Previous Clinical Trials
597,483 Total Patients Enrolled
SanofiIndustry Sponsor
2,209 Previous Clinical Trials
4,039,741 Total Patients Enrolled
Michael Scorder, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and follow the study's requirements.I am HIV positive or have an active hepatitis infection.My organs are functioning well.My condition didn't improve after trying at least 2 treatments including steroids, IVIG, or rituximab.I do not have any uncontrolled health conditions that pose a high risk.My cancer returned or worsened after a stem cell transplant.I am 18 years old or older.My disease is in remission after a stem cell transplant.I have been diagnosed with immune conditions like AIHA, ITP, or PRCA.My previous treatment did not fully work on my condition.I do not have an active hepatitis infection nor am I being treated for one.I agree not to donate sperm and to use birth control.I cannot take certain medications due to adverse reactions.I have anemia or low platelet count due to a complication after a transplant.I am currently receiving treatment for severe graft-versus-host disease.I am not pregnant and agree to use birth control.I had a stem cell transplant from a donor more than 45 days ago.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Refractory Immune Cytopenias
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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