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Magrolimab for Acute Myeloid Leukemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
CHU d'Angers, Angers, FranceAcute Myeloid LeukemiaMagrolimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of two different treatment regimens for people with a certain type of leukemia who can't have intensive chemotherapy.

Eligible Conditions
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

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Study Objectives

2 Primary · 13 Secondary · Reporting Duration: Up to 5 years

Year 5
Magnitude of Anti-Magrolimab Antibody Incidence
Antibodies
Serum Concentration of Magrolimab
Year 5
Blood Transfusion
Year 5
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Year 5
Overall Survival (OS)
Year 5
Event-Free Survival (EFS)
TUDD on the EORTC QLQ-C30 Physical Functioning Scale
Time Until Meaningful Definitive Deterioration (TUDD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale
Up to 5 years
Duration of CR + CRh in Participants who achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh)
Duration of Complete Remission (DCR) in Participants who achieved Complete Remission (CR)
Up to 7 months
Complete Remission (CR)
Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh)
Rate of Complete Remission Without Minimal Residual Disease (CRMRD-)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Blinatumomab
1
Uproleselan
1
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Side Effects for

Magrolimab 10 mg/kg
67%Dry skin
44%Diarrhoea
44%Fatigue
44%Lymphocyte count decreased
44%Dermatitis acneiform
33%Abdominal pain
33%Infusion related reaction
22%Dehydration
22%Oedema peripheral
22%Pruritus
22%Decreased appetite
22%Back pain
22%Chills
22%Headache
22%Rash maculo-papular
22%Tinnitus
22%Nausea
22%Myalgia
22%Small intestinal obstruction
11%Confusional state
11%Sinusitis
11%Tinea cruris
11%Gastrointestinal stoma complication
11%Hypokalaemia
11%Lymphopenia
11%Photopsia
11%Oesophageal pain
11%Conjunctivitis
11%Folliculitis
11%Tumour pain
11%Dysphonia
11%Ingrowing nail
11%Deep vein thrombosis
11%Hypertension
11%Hypophosphataemia
11%Somnolence
11%Haematuria
11%Dyspnoea
11%Nasal congestion
11%Conjunctivitis allergic
11%Cerebrovascular accident
11%Dyspepsia
11%Chest discomfort
11%Arthralgia
11%Palpitations
11%Constipation
11%Vomiting
11%Hypoaesthesia oral
11%Alanine aminotransferase increased
11%Hyperglycaemia
11%Depression
11%Dry eye
11%Malignant neoplasm progression
11%Anaemia
11%Gastroenteritis viral
11%Skin infection
11%Aspartate aminotransferase increased
11%Platelet count decreased
11%Dizziness
11%Hypomagnesaemia
11%Abdominal distension
11%Blood bilirubin increased
11%Neck pain
11%Gastrooesophageal reflux disease
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT02953782) in the Magrolimab 10 mg/kg ARM group. Side effects include: Dry skin with 67%, Diarrhoea with 44%, Fatigue with 44%, Lymphocyte count decreased with 44%, Dermatitis acneiform with 44%.

Trial Design

2 Treatment Groups

Magrolimab + Venetoclax + Azacitidine
1 of 2
Magrolimab Placebo + Venetoclax + Azacitidine
1 of 2

Experimental Treatment

Non-Treatment Group

432 Total Participants · 2 Treatment Groups

Primary Treatment: Magrolimab · Has Placebo Group · Phase 3

Magrolimab + Venetoclax + AzacitidineExperimental Group · 3 Interventions: Venetoclax, Magrolimab, Azacitidine · Intervention Types: Drug, Biological, Drug
Magrolimab Placebo + Venetoclax + AzacitidinePlaceboComparator Group · 3 Interventions: Venetoclax, Azacitidine, Magrolimab Placebo · Intervention Types: Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Magrolimab
Not yet FDA approved
Azacitidine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,030 Previous Clinical Trials
771,383 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
329 Previous Clinical Trials
183,713 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What does the scientific community know about Magrolimab from past research?

"In 2006, researchers first studied magrolimab at Chinese University of Hong Kong-Prince of Wales Hospital. As of today, there have been a total of 213 completed clinical trials. There are currently 360 active ones with many taking place in Baltimore, Maryland." - Anonymous Online Contributor

Unverified Answer

For what purpose is Magrolimab most often employed?

"Magrolimab is most often used as part of induction chemotherapy. Additionally, this medication can be prescribed to treat conditions like refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia." - Anonymous Online Contributor

Unverified Answer

How many people are the doctors hoping to test this on?

"In order to begin the trial, 432 patients who meet specific requirements must enroll. Those interested in participating can do so at University of Maryland, Greenebaum Comprehensive Cancer Center in Baltimore, Maryland or Wake Forest Baptist Health in Winston-Salem, North Carolina." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies in this particular clinical trial?

"Yes, this is an ongoing study that has been advertised on clinicaltrials.gov since July 7th, 2020. The trial requires 432 patients to be enrolled at seven different medical facilities." - Anonymous Online Contributor

Unverified Answer

How has Magrolimab been received by the FDA?

"Magrolimab's safety is supported by both efficacy data and multiple rounds of research, so it received a score of 3." - Anonymous Online Contributor

Unverified Answer

Are there many places in town where this experiment is taking place?

"At the moment, there are 7 sites where you can enroll in this study. They are situated in Baltimore, Winston-Salem and Fort Sam Houston as well as 4 other locations. If you want to cut down on travel time, then it would be best to select a location near you." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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