Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years
- All subjects must have histologically or pathologically confirmed diagnosis of their
malignancy and/or measurable R/R disease, as follows:
1. Cohort 1 only: Refractory or relapsed acute leukemia defined as > 5% blasts in
the bone marrow or reappearance of blasts in the peripheral blood
2. Cohort 2 only: Previously treated, pathologically confirmed de novo DLBCL, or
DLBCL transformed from previously indolent lymphoma (e.g., follicular lymphoma)
with documented clinical or radiological evidence of progressive or persistent
disease. At study entry, subjects must have measurable disease as per the revised
criteria for response assessment of lymphoma.
3. Cohort 3 only: Measurable MM based on IMWG (International Myeloma Working Group)
guidelines
Patients must be refractory or must have progressed on, or following discontinuation of the
most recent anti-cancer therapy, with the following considerations:
1. Cohort 1 only: Have failed or are ineligible for any approved standard of care
therapies, including HSCT (Hematopoietic Stem Cell Transplantation)
2. Cohort 2 only: Must have received at least 2 but no more than 5 previous systemic
regimens for the treatment of their de novo or transformed DLBCL (i.e., transformed
from a previously diagnosed indolent lymphoma [e.g., follicular lymphoma])
3. Cohort 3 only: Must have received at least 3 but no more than 6 prior anti-MM regimens
including proteasome inhibitor (e.g., bortezomib or carfilzomib) and immunomodulatory
drug (IMiD) (e.g., lenalidomide or pomalidomide) therapy.
Exclusion Criteria:
Subjects who meet any of the following criteria will not be enrolled in the study (all
cohorts, unless otherwise indicated):
- Certain disease subtypes or occurrences, as follows:
1. Cohort 1: acute promyelocytic leukemia (APL), chronic myeloid leukemia (CML) in
blast crisis, isolated extramedullary relapse (iEMR).
2. Cohort 2: Primary mediastinal B-cell lymphoma (PMBCL), DLBCL transformed from
diseases other than indolent non-Hodgkin's Lymphoma (NHL)
3. Cohort 3: Active plasma cell leukemia, myeloma with amyloidosis, systemic light
chain amyloidosis
- White Blood Count (WBC) > 25,000/ µL (uncontrollable with cytoreductive therapy)
- Known central nervous involvement, as follows:
1. Cohort 1: Clinically active central nervous system (CNS) leukemia. Previously
controlled CNS leukemia is acceptable
2. Cohort 2: Active CNS lymphoma or meningeal involvement
- Prior menin inhibitor therapy
- Known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B
surface antigen
- Subjects with a pre-existing disorder predisposing them to a serious or
life-threatening infection (e.g., cystic fibrosis, congenital or acquired
immunodeficiency, bleeding disorder, or cytopenias not related to acute leukemia,
DLBCL, or MM)
- An active uncontrolled acute or chronic systemic fungal, bacterial, or viral infection
Eligibility last updated 4/4/22. Questions regarding updates should be directed to the study team contact.