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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02953509
Registration number
NCT02953509
Ethics application status
Date submitted
1/11/2016
Date registered
2/11/2016
Date last updated
23/05/2024
Titles & IDs
Public title
Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
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Scientific title
A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
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Secondary ID [1]
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2016-003408-29
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Secondary ID [2]
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5F9003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non Hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Magrolimab
Treatment: Drugs - Rituximab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Oxaliplatin
Experimental: Magrolimab + Rituximab, Phase 1b Dose Escalation - 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.
Experimental: Magrolimab + Rituximab, Phase 2 Indolent Lymphoma - 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.
Experimental: Magrolimab + Rituximab, Phase 2 Diffuse Large B-Cell lymphoma - 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.
Experimental: Magrolimab + R-GemOx, Phase 1b Safety Dose Escalation Phase - 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.
Experimental: Magrolimab + R-GemOx, Phase 1b Dose Expansion Phase - 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: Drugs: Magrolimab
Administered intravenously
Treatment: Drugs: Rituximab
Administered intravenously on Days 8, 15, and 22 during Cycle 1, followed by 1 dose on Day 1 for Cycles 2 through 6, and Day 1 for every other cycle until Cycle 13
Treatment: Drugs: Gemcitabine
Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4
Treatment: Drugs: Oxaliplatin
Administered intravenously on Days 11, 23 for Cycle 1 and Days 2 and 15 for Cycles 2 to 4
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs)
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Assessment method [1]
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DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment in participant in Phase 1b.
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Timepoint [1]
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Up to 28 days
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Primary outcome [2]
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Percentage of Participants Experiencing Treatment Emergent Adverse Events
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Assessment method [2]
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Timepoint [2]
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First dose date up to 5 years
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Primary outcome [3]
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Objective Response Rate as Defined by the Investigator According to the Lugano Classification for Lymphomas
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Assessment method [3]
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Objective response is defined as complete response (CR) + partial response (PR) determined by Lugano classification for lymphomas.
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Timepoint [3]
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Up to 5 months
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Secondary outcome [1]
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PK Parameter of Magrolimab: AUClast
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Assessment method [1]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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Timepoint [1]
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Before magrolimab infusion (within 12 hours) on Day 1, 8, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycles 3, 4, 5, 9, and 13 and until safety follow-up visit (30 days ± 7 days after last dose of magrolimab); Cycle length is 28 days
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Secondary outcome [2]
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PK Parameter of Rituximab: AUClast
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Assessment method [2]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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Timepoint [2]
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Before rituximab infusion (within 12 hours) on Day 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycles 3 - 6; Cycle length is 28 days
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Secondary outcome [3]
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PK Parameter of Magrolimab: AUCtau
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Assessment method [3]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [3]
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Before magrolimab infusion (within 12 hours) on Day 1, 8, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycles 3, 4, 5, 9, and 13 and until safety follow-up visit (30 days ± 7 days after last dose of magrolimab); Cycle length is 28 days
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Secondary outcome [4]
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PK Parameter of Rituximab: AUCtau
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Assessment method [4]
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AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
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Timepoint [4]
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Before rituximab infusion (within 12 hours) on Day 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycles 3 - 6; Cycle length is 28 days
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Secondary outcome [5]
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PK Parameter of Magrolimab: Cmax
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Assessment method [5]
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Cmax is defined as the maximum observed concentration of drug.
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Timepoint [5]
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Before magrolimab infusion (within 12 hours) on Day 1, 8, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycles 3, 4, 5, 9, and 13 and until safety follow-up visit (30 days ± 7 days after last dose of magrolimab); Cycle length is 28 days
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Secondary outcome [6]
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PK Parameter of Rituximab: Cmax
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Assessment method [6]
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Cmax is defined as the maximum observed concentration of drug.
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Timepoint [6]
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Before rituximab infusion (within 12 hours) on Day 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycles 3 - 6; Cycle length is 28 days
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Secondary outcome [7]
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Percentage of Participants who Developed Anti-Magrolimab Antibodies
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Assessment method [7]
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Timepoint [7]
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Day 1 of Cycle 1 to 5, Day 1 Cycle 9, 13, and until safety follow-up visit (30 days ± 7 days after last dose of magrolimab); Cycle length is 28 days
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Secondary outcome [8]
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Duration of Response
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Assessment method [8]
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The duration of response is measured from when the first (objective) response is met (i.e., complete response or partial response) until the first date of objectively documented progressive disease.
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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Progression Free Survival
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Assessment method [9]
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Progression free survival is measured from dose initiation until the first date of objectively documented disease progression or death.
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Timepoint [9]
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Up to 5 years
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Secondary outcome [10]
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Overall Survival
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Assessment method [10]
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Overall Survival is measured from dose initiation until death.
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Timepoint [10]
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Up to 5 years
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Secondary outcome [11]
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Time to Progression
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Assessment method [11]
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Time to Progression is measured from dose initiation until the first date of objectively documented progressive disease criteria.
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Timepoint [11]
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First dose date up to 5 years
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Secondary outcome [12]
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Objective Rate of Response Defined by the Investigator According to the LYRIC Criteria for Lymphomas
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Assessment method [12]
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Objective response is defined as complete response + partial response determined by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) criteria.
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Timepoint [12]
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Up to 5 months
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Eligibility
Key inclusion criteria
Key
- Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard
approved therapies
- DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL)
expressing CD 20, relapsed or refractory to at least 2 prior lines treatment
containing anti-CD20 therapy
- Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, 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
- Adequate performance status and hematological, liver and kidney functions
- Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Active brain metastases
- Prior allogeneic hematopoietic cell transplantation
- Prior treatment with CD47 or signal regulatory protein alpha (SIRPa) targeting agents
- Second malignancy within the last 3 years
- Known active or chronic hepatitis B or C infection or HIV
- Pregnancy or active breastfeeding
- Prior chimeric antigen receptor (CAR-T) therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/03/2024
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Sample size
Target
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Accrual to date
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Final
178
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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St. Vincent's Hospital Melbourne - Melbourne
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Recruitment hospital [3]
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Linear Clinical Research Ltd - Nedlands
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Recruitment postcode(s) [2]
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3065 - Melbourne
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Maryland
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Country [6]
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United States of America
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State/province [6]
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Massachusetts
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Country [7]
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United States of America
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State/province [7]
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Michigan
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Country [8]
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United States of America
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State/province [8]
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Minnesota
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Country [9]
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United States of America
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State/province [9]
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Missouri
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Country [10]
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United States of America
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State/province [10]
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North Carolina
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Country [11]
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United States of America
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State/province [11]
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Oklahoma
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Country [12]
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United States of America
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State/province [12]
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Pennsylvania
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Country [13]
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United States of America
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State/province [13]
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Tennessee
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Country [14]
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United States of America
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State/province [14]
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Texas
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Country [15]
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United Kingdom
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State/province [15]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Other collaborator category [1]
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Other
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Name [1]
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The Leukemia and Lymphoma Society
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objectives of this study are:
- To investigate the safety and tolerability, and to define the recommended Phase 2 dose
and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in
combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx).
- To evaluate the efficacy of magrolimab in combination with rituximab in participants
with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the
efficacy of magrolimab in combination with R-GemOx in autologous stem cell transplant
(ASCT) ineligible DLBCL participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02953509
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02953509
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