All > Sezary Syndrome

Magrolimab for Mycosis Fungoides

Northwestern University, Chicago, IL
Mycosis Fungoides+18 More ConditionsMagrolimab - Biological
Eligibility
18+
All Sexes

Study Summary

This trial is testing magrolimab in combination with mogamulizumab to see if it can help patients with T-cell lymphoma that has come back or does not respond to treatment. Magrolimab and mogamulizumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread.

Eligible Conditions
  • Mycosis Fungoides
  • Mycosis Fungoides and Sezary Syndrome
  • Sezary Syndrome
  • Cutaneous T-Cell Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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1
Venetoclax
1
Pembrolizumab administered using the Sofusa® DoseConnect™
1
Magrolimab

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 2 years

At 12 months
Overall response rate at 12 months (ORR12)
At 4 months
Overall response rate at 4 months (ORR4)
At 6 months
Overall response rate at 6 months (ORR6) (Phase II)
Year 2
Progression-free survival (PFS)
Year 2
Time to next treatment (TTNT)
Year 2
Duration of response (DOR)
Up to 2 years
Overall response rate (ORR)
Week 4
Recommended phase 2 dose (RP2D) of magrolimab when given in combination with mogamulizumab (Phase Ib)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Venetoclax
1
Pembrolizumab administered using the Sofusa® DoseConnect™
1
Magrolimab

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%Decreased appetite
22%Dehydration
22%Headache
22%Back pain
22%Oedema peripheral
22%Rash maculo-papular
22%Chills
22%Pruritus
22%Tinnitus
22%Nausea
22%Myalgia
22%Small intestinal obstruction
11%Folliculitis
11%Hypoaesthesia oral
11%Dyspnoea
11%Dyspepsia
11%Conjunctivitis allergic
11%Deep vein thrombosis
11%Hypertension
11%Lymphopenia
11%Palpitations
11%Tumour pain
11%Confusional state
11%Somnolence
11%Oesophageal pain
11%Vomiting
11%Conjunctivitis
11%Sinusitis
11%Ingrowing nail
11%Alanine aminotransferase increased
11%Constipation
11%Tinea cruris
11%Depression
11%Dry eye
11%Gastrointestinal stoma complication
11%Hypophosphataemia
11%Photopsia
11%Chest discomfort
11%Hyperglycaemia
11%Dysphonia
11%Nasal congestion
11%Cerebrovascular accident
11%Hypokalaemia
11%Arthralgia
11%Haematuria
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%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm II (mogamulizumab), Phase II
1 of 2
Arm I (magrolimab, mogamulizumab), Phase Ib and Phase II
1 of 2

Active Control

Experimental Treatment

88 Total Participants · 2 Treatment Groups

Primary Treatment: Magrolimab · No Placebo Group · Phase 1 & 2

Arm I (magrolimab, mogamulizumab), Phase Ib and Phase IIExperimental Group · 6 Interventions: Biospecimen Collection, Computed Tomography, Punch Biopsy, Positron Emission Tomography, Magrolimab, Mogamulizumab · Intervention Types: Procedure, Procedure, Procedure, Procedure, Biological, Biological
Arm II (mogamulizumab), Phase IIActiveComparator Group · 6 Interventions: Biospecimen Collection, Computed Tomography, Punch Biopsy, Positron Emission Tomography, Magrolimab, Mogamulizumab · Intervention Types: Procedure, Procedure, Procedure, Procedure, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~810
Computed Tomography
2017
Completed Phase 2
~2710
Punch Biopsy
2017
N/A
~40
Positron Emission Tomography
2008
Completed Phase 2
~2290
Magrolimab
Not yet FDA approved
Mogamulizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,283 Previous Clinical Trials
41,235,310 Total Patients Enrolled
105 Trials studying Mycosis Fungoides
4,475 Patients Enrolled for Mycosis Fungoides
Michael S KhodadoustPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have received treatment for your disease before.
References

Frequently Asked Questions

What objectives do investigators hope to meet with this experiment?

"This trial will evaluate the primary outcome of Overall Response Rate at 6 months (ORR6) over a period spanning 4 weeks from receiving the initial magrolimab infusion. Secondary outcomes include ORR12, defined by patients having a partial or complete response for 12+ months; ORR, marked by global response score; and PFS observed through Kaplan-Meier method and log-rank test." - Anonymous Online Contributor

Unverified Answer

What is the upper limit of participants involved in this research?

"Yes, the information provided on clinicaltrials.gov confirms that recruitment for this trial is still underway. Initially posted in December 2020 and last updated in November 2022, it requires 88 participants to be recruited at two separate sites." - Anonymous Online Contributor

Unverified Answer

Are there other precedents for Magrolimab's efficacy in clinical testing?

"Magrolimab was first studied in 2013 at Aichi Medical University, with 80 concluded trials and 25 presently active ones. Most of these current studies are being conducted from a medical facility located in Duarte, California." - Anonymous Online Contributor

Unverified Answer

Is enrollment open for this investigational study?

"According to clinicaltrials.gov, the recruitment process for this medical study is ongoing; it was initially published on December 24th 2020 and last updated on November 10th 2022." - 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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