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Monoclonal Antibodies

Magrolimab + Pembrolizumab for Hodgkin's Lymphoma

Phase 2
Recruiting
Led By Ranjana H Advani, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Prior treatment with at least two systemic therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test if magrolimab, when combined with pembrolizumab, is safe and effective in treating patients with Hodgkin lymphoma.

Who is the study for?
Adults over 18 with relapsed or refractory classic Hodgkin Lymphoma (cHL) who've had at least two prior treatments can join. They must have a certain level of blood cells, organ function, and no recent severe illnesses or second cancers. Participants need to use effective birth control and not be pregnant.Check my eligibility
What is being tested?
The trial is testing the combination of Magrolimab and Pembrolizumab for safety and effectiveness in treating cHL. Patients will undergo PET/CT imaging to measure disease activity before and during treatment.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related responses, changes in blood counts, fatigue, possible organ inflammation like pneumonitis, as well as risks associated with hormonal contraception methods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have undergone at least two different treatments for my condition.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am a man who can father children and will use contraception during and 4 months after the study.
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My white blood cell count is healthy without needing medication.
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I have taken a pregnancy test recently and it was negative.
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I have taken a pregnancy test recently and it was negative.
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I am a man who can father a child and will use contraception during and 4 months after the study.
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My Hodgkin lymphoma has returned or is not responding to treatment.
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My white blood cell count is healthy without needing medication in the last 3 weeks.
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My Hodgkin lymphoma has returned or is not responding to treatment.
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I have undergone at least two different treatments for my condition.
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I am 18 years old or older.
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I am 18 years old or older.
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My PET scan shows active cancer.
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My PET scan shows active cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR)
Secondary outcome measures
Magrolimab related Adverse Events
Other outcome measures
Overall Response (OR)

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782
67%
Dry skin
44%
Diarrhoea
44%
Dermatitis acneiform
44%
Fatigue
44%
Lymphocyte count decreased
33%
Infusion related reaction
33%
Abdominal pain
22%
Decreased appetite
22%
Small intestinal obstruction
22%
Tinnitus
22%
Nausea
22%
Chills
22%
Oedema peripheral
22%
Back pain
22%
Myalgia
22%
Headache
22%
Pruritus
22%
Dehydration
22%
Rash maculo-papular
11%
Hypertension
11%
Dyspnoea
11%
Lymphopenia
11%
Malignant neoplasm progression
11%
Cerebrovascular accident
11%
Anaemia
11%
Palpitations
11%
Conjunctivitis allergic
11%
Dry eye
11%
Abdominal distension
11%
Constipation
11%
Dyspepsia
11%
Gastrooesophageal reflux disease
11%
Hypoaesthesia oral
11%
Folliculitis
11%
Sinusitis
11%
Gastrointestinal stoma complication
11%
Aspartate aminotransferase increased
11%
Blood bilirubin increased
11%
Hypokalaemia
11%
Hypomagnesaemia
11%
Hypophosphataemia
11%
Tumour pain
11%
Dizziness
11%
Confusional state
11%
Depression
11%
Haematuria
11%
Dysphonia
11%
Ingrowing nail
11%
Skin infection
11%
Tinea cruris
11%
Platelet count decreased
11%
Alanine aminotransferase increased
11%
Photopsia
11%
Conjunctivitis
11%
Gastroenteritis viral
11%
Hyperglycaemia
11%
Arthralgia
11%
Neck pain
11%
Somnolence
11%
Nasal congestion
11%
Deep vein thrombosis
11%
Oesophageal pain
11%
Vomiting
11%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only

Trial Design

1Treatment groups
Experimental Treatment
Group I: Magrolimab (Hu5F9 G4) and pembrolizumabExperimental Treatment3 Interventions
All subjects will have a baseline PET CT and excisional or core needle biopsy within 1 month of study enrollment and baseline electrocardiogram and laboratory studies within 1 week of study enrollment. All subjects will receive treatment with magrolimab and pembrolizumab according to the dosing schedule. Magrolimab IV given on cycle 1, 2 and 3. Pembrolizumab 200 mg IV given on Cycle 1, 2 and 3. Patients may continue to receive treatment on the study for a maximum of 24 months or until progression of disease, unacceptable toxicity, or bridge to stem cell transplantation (SCT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magrolimab
2021
Completed Phase 2
~170
Pembrolizumab
2017
Completed Phase 2
~2010
PET/CT
2022
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,339 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,975 Total Patients Enrolled
Ranjana H Advani, MDPrincipal InvestigatorStanford Universiy
2 Previous Clinical Trials
115 Total Patients Enrolled

Media Library

Magrolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04788043 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Magrolimab (Hu5F9 G4) and pembrolizumab
Hodgkin's Lymphoma Clinical Trial 2023: Magrolimab Highlights & Side Effects. Trial Name: NCT04788043 — Phase 2
Magrolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04788043 — Phase 2

Frequently Asked Questions

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

What diseases or conditions has Magrolimab been clinically proven to ameliorate?

"Magrolimab is well-known for treating malignant neoplasms, but has also been used to address unresectable melanoma, microsatellite instability high syndrome and post-chemotherapy progression of illnesses."

Answered by AI

Are there any existing reports on the efficacy of Magrolimab?

"Currently, there are 975 active clinical studies involving Magrolimab and 125 trials in the penultimate phase of development. Texas' Houston is a hub for this drug's research with numerous ongoing trials, while 36276 locations across the world have Magrolimab-related experiments running."

Answered by AI

Are there still vacancies available to join this investigation?

"The trial is actively recruiting, as confirmed on clinicaltrials.gov. This investigation was initially advertised on June 21st 2022 and its details were updated most recently on the same date."

Answered by AI

What is the current level of participation in this experiment?

"Affirmative. As indicated on the clinicaltrials.gov website, this research study was initially uploaded on June 21st 2022 and is currently accepting applicants to join in its endeavour. 24 participants are being sought out across a single site for recruitment."

Answered by AI

What adverse effects have been associated with Magrolimab usage?

"Magrolimab is currently classified as a 2 on the safety scale due to its Phase 2 status, which implies there are data confirming it safe but not yet supportive of efficacy."

Answered by AI
~7 spots leftby Dec 2024