©2024 Stanford Medicine
Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma
Recruiting
I'm InterestedTrial ID: NCT04788043
Purpose
The purpose of this study is to test the safety and efficacy of magrolimab in combination
with pembrolizumab in patients with Hodgkin lymphoma.
Official Title
A Phase 2 Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma
Stanford Investigator(s)
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Eligibility
Inclusion Criteria:
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Biopsy proven relapsed or refractory cHL
- Prior treatment with at least two systemic therapies
- Metabolically active measurable disease by PET imaging per the 2014 Lugano criteria
- Hemoglobin ≥ 9.5 g/dL
- Absolute neutrophil count ≥ 1,000 cells/μL without G-CSF support within 3 weeks prior
to enrollment
- Platelet count ≥ 75,000 cells/μL
- Creatinine clearance > 40 mL/min per the Cockroft-Gault formula
- Total bilirubin < 1.5 x upper limit of normal (ULN) (or < 3.0 x ULN and primarily
unconjugated in subjects with a history of Gilbert's syndrome)
- Negative urine or serum pregnancy test within 30 days of enrollment and within 72
hours before the first administration of magrolimab for women of childbearing
potential
- Women of childbearing potential must be willing to use at least 1 highly effective
method of contraception during the study and continue for 4 months after the last dose
of magrolimab
- Male subjects who are sexually active with a woman of childbearing potential and who
have not had vasectomies must be willing to use a barrier method of contraception
during the study and for 4 months after the last dose of magrolimab
- Ability to understand and the willingness to sign the written IRB approved informed
consent document
- Must be willing and able to comply with the clinic visits and procedures outlined in
the study protocol
Exclusion Criteria:
- Prior treatment with a PD-1 inhibitor within 3 months prior to enrollment
- Prior treatment with antibodies targeting CD47 or SIRPα2
- Prior allogeneic hematopoietic cell transplantation
- Systemic autoimmune disorder on chronic immunosuppression (defined as ≥ 10 mg of
prednisone daily)
- RBC transfusion dependence, defined as requiring more than 2 units of RBCs during the
4-week period prior to screening
- History of hemolytic anemia, autoimmune thrombocytopenia, or Evan's syndrome within
the last 3 months
- Second malignancy not in complete remission for at least 1 year, excluding fully
resected non melanoma skin cancer or localized prostate cancer
- Women who are pregnant or breast feeding
- HIV or hepatitis B or C infection with active viral replication by PCR
- Second malignancy not in complete remission for at least 1 year, excluding fully
resected non-melanoma skin cancer or localized prostate cancer
- Active cardiac disease including unstable angina, decompensated congestive heart
failure, or severe uncontrolled conduction abnormalities
- History of non-infectious pneumonitis requiring corticosteroids or current pneumonitis
- Significant medical conditions, as assessed by the investigators and IND holder, that
would substantially increase the risk benefit ratio of participating in the study
- History of psychiatric illness or substance abuse likely to interfere with ability to
comply with protocol requirements
- Received a live or live attenuated vaccine within 30 days before the first dose of
study intervention
- Received any anti-cancer therapy within 2 weeks prior to the first dose of study
intervention
Intervention(s):
drug: Magrolimab
drug: Pembrolizumab
procedure: PET/CT
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Austin Yeung
650-736-1908