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Monoclonal Antibodies

Magrolimab + Rituximab/Chemotherapy for Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard approved therapies

DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of magrolimab, in combination with other drugs, for the treatment of lymphoma. The trial will also help to determine the best dose and schedule of magrolimab for future studies.

Who is the study for?

This trial is for adults with B-cell non-Hodgkin's lymphoma that has come back or didn't respond to standard treatments. Participants must have tried at least two prior therapies including anti-CD20 therapy and be willing to undergo tumor biopsies before and during treatment.Check my eligibility

What is being tested?

The study tests Magrolimab in combination with Rituximab, or together with Rituximab plus chemotherapy drugs Gemcitabine and Oxaliplatin. It aims to find a safe dose, assess how well the combinations work for different types of this lymphoma, and if they're suitable for patients ineligible for stem cell transplant.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to Magrolimab, infusion-related symptoms from Rituximab, as well as nausea, low blood counts, fatigue from chemotherapy agents like Gemcitabine and Oxaliplatin.

Eligibility Criteria

Inclusion Criteria

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

Select...

My B-cell non-Hodgkin's lymphoma has not responded to standard treatments.

Select...

My DLBCL has not responded to 1-3 previous treatments.

Select...

My DLBCL has not responded to at least 2 prior treatments including anti-CD20 therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Lymphoma

Percentage of Participants Experiencing Treatment Emergent Adverse Events

Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs)

Secondary outcome measures

Duration of Response

Objective Rate of Response Defined by the Investigator According to the LYRIC Criteria for Lymphomas

Overall Survival

+9 more

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%

Myalgia

22%

Decreased appetite

22%

Small intestinal obstruction

22%

Tinnitus

22%

Nausea

22%

Chills

22%

Oedema peripheral

22%

Back pain

22%

Headache

22%

Pruritus

22%

Dehydration

22%

Rash maculo-papular

11%

Hypokalaemia

11%

Dyspepsia

11%

Tumour pain

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%

Gastrooesophageal reflux disease

11%

Hypoaesthesia oral

11%

Folliculitis

11%

Sinusitis

11%

Gastrointestinal stoma complication

11%

Aspartate aminotransferase increased

11%

Blood bilirubin increased

11%

Hypomagnesaemia

11%

Hypophosphataemia

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%

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

5Treatment groups

Experimental Treatment

Group I: Magrolimab + Rituximab, Phase 2 Indolent LymphomaExperimental Treatment2 Interventions

Participants with indolent lymphoma will receive magrolimab based on RP2DS from Phase 1b portion of the study in combination with rituxumab 375 mg/m^2.

Group II: Magrolimab + Rituximab, Phase 2 Diffuse Large B-Cell lymphomaExperimental Treatment2 Interventions

Participants with diffuse large B-cell lymphoma (DLBCL) will receive magrolimab based on RP2DS from Phase 1b portion of the study in combination with rituxumab 375 mg/m^2.

Group III: Magrolimab + Rituximab, Phase 1b Dose EscalationExperimental Treatment2 Interventions

Participants with B-cell non-Hodgkin's lymphoma will receive 1 mg/kg magrolimab priming dose on Day 1 of Cycle 1 followed by weekly maintenance doses of 10, 20, 30, or 45 mg/kg on Days 8, 15, 22 for Cycle 1 and Days 1, 8, 15, and 22 for each cycle to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose and schedule (RP2DS) in combination with rituxumab 375 mg/m^2. Cycle length is 28 days.

Group IV: Magrolimab + R-GemOx, Phase 1b Safety Dose Escalation PhaseExperimental Treatment4 Interventions

Autologous stem cell transplant (or transplantation) ineligible DLBCL participants will receive 1 mg/kg magrolimab priming dose on Day 1 for Cyle 1 followed by maintenance doses of 30 or 45 mg/kg on Days 8, 11, 15, 22, and 29 for Cycle 1, every week for Cycle 2, and every 2 weeks for each cycle to determine maximum tolerated dose (MTD) + rituxumab 375 mg/m^2 + gemcitabine 1000 mg/m^2 + oxaliplatin 100 mg/m^2. Cycle length is 28 days.

Group V: Magrolimab + R-GemOx, Phase 1b Dose Expansion PhaseExperimental Treatment4 Interventions

Autologous stem cell transplant (or transplantation) ineligible DLBCL participants will receive magrolimab at a dose determined from Phase 1b Safety Dose-Escalation Phase in combination with rituxumab 375 mg/m^2 + gemcitabine 1000 mg/m^2 + oxaliplatin 100 mg/m^2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magrolimab

2021

Completed Phase 2

~170

Rituximab

1999

Completed Phase 4

~1880

Gemcitabine

2017

Completed Phase 3

~2070

Oxaliplatin

2011

Completed Phase 4

~2560

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,082 Previous Clinical Trials

842,663 Total Patients Enrolled

The Leukemia and Lymphoma SocietyOTHER

82 Previous Clinical Trials

16,953 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,657 Total Patients Enrolled

Media Library

Magrolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02953509 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: Magrolimab + R-GemOx, Phase 1b Safety Dose Escalation Phase, Magrolimab + R-GemOx, Phase 1b Dose Expansion Phase, Magrolimab + Rituximab, Phase 1b Dose Escalation, Magrolimab + Rituximab, Phase 2 Indolent Lymphoma, Magrolimab + Rituximab, Phase 2 Diffuse Large B-Cell lymphoma

Non-Hodgkin's Lymphoma Clinical Trial 2023: Magrolimab Highlights & Side Effects. Trial Name: NCT02953509 — Phase 1 & 2

Magrolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02953509 — Phase 1 & 2

Frequently Asked Questions

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

In how many locations is the experiment currently being conducted?

"16 medical centres are recruiting participants in this study, including The Sarah Cannon Research Institute located in Nashville, the Georgia Cancer Centre at Augusta University situated in Augusta and the University of Chicago Medical Center based in Chicago. Additionally there are 13 other sites enrolling patients."

Answered by AI

Are there any prior clinical assessments of Magrolimab?

"Presently, Magrolimab is the subject of 1,126 active trials with 331 in Phase 3. Out of 51,168 sites running studies for this medication, most are located in Guangzhou, Guangdong province."

Answered by AI

What medical conditions can Magrolimab be employed to treat?

"Magrolimab is a common treatment for dlbcl, but it can also be utilized to address sclc, head and neck carcinoma, and cervical cancer."

Answered by AI

Is there capacity to accommodate more participants in this experiment?

"The information found on clinicaltrials.gov states that this particular trial, which was initially posted in November 2016 and later revised in June 2022, is not currently accepting new participants. Fortunately, there are over 2900 other studies where recruitment is ongoing at the moment."

Answered by AI

What is the upper limit of enrollees involved in this clinical trial?

"Unfortunately, this research endeavour is not currently seeking participants. It was initially posted on the 21st of November in 2016 and recently revised on June 8th 2022. In case you are interested in a similar investigation, there presently exist 1795 scientific trials actively recruiting patients with lymphoma as well as 1126 investigations that use Magrolimab which require enrollees."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

CD47 Blockade by Hu5f9-g4 and Rituximab in Non-hodgkin’s Lymphoma

Advani, Ranjana, Ian Flinn, Leslie Popplewell, Andres Forero, Nancy L. Bartlett, Nilanjan Ghosh, Justin Kline, et al.. 2018. “CD47 Blockade by Hu5f9-g4 and Rituximab in Non-hodgkin’s Lymphoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1807315.

clinicaltrials.govStudy

Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

2016. "Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02953509.

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