Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Curis, Inc.
With
The Leukemia and Lymphoma Society
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients ≥ 18 years of age with any of the following: Histopathologically confirmed DLBCL or HGBL (i.e., HGBL with MYC, BCL2, and/or BCL6 rearrangements, HGBL, not otherwise specified \[NOS\], or DLBCL, NOS) that is refractory to, or has relapsed after, treatment with at least 1 prior regimen. Eligible sub-types include DHL, THL, or DEL, as well as DLBCL or HGBL without MYC and/or BCL2 alterations. Criteria for DHL are concurrent MYC translocation+ and BCL2 translocation+ by fluorescence in situ hybridization (FISH) (same criteria for THL, which also includes BCL6 translocation+ by FISH); criteria for DEL are concurrent overexpression of MYC (≥ 40%) and BCL2 (\> 50%) by immunohistochemistry (IHC).
Measurable disease by CT or PET/CT. MRI acceptable as per protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments (excluding alopecia).
Absolute neutrophil count ≥ 1,000/µL; platelets ≥ 75,000/µL for patients with no bone marrow involvement by malignancy; platelets ≥ 50,000/µL for patients with bone marrow involvement by malignancy.
Creatinine ≤ 1.5x upper limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN.
Life expectancy of at least 3 months.
You may not be if
Intention to undergo stem cell transplant (SCT) or treatment with chimeric antigen receptor (CAR) T-cell therapy.
SCT therapy within 100 days prior to starting study treatment.
Systemic anti-cancer therapy or investigational agent within 3 weeks of study entry, except for nitrosoureas or mitomycin C (6 weeks).
Other non-cytotoxic anti-cancer therapy or investigational agent within 5 half-lives or 21 days prior to study treatment, whichever is shorter, as long as any drug related toxicities have resolved to Grade 1 or less. Dexamethasone up to 12 mg/d is allowed as supportive therapy and does not exclude participation.
Contraindication to venetoclax or rituximab.
Progressive disease during treatment or within 3 months of stopping prior treatment with a BCL2 inhibitor, histone deacetylase (HDAC) inhibitor, or phosphoinositide-3 kinase (PI3k) inhibitor, or prior discontinuation of any of these therapies due to clinically significant toxicity.
Graft vs. host disease following prior allogeneic transplant within 3 months prior to study treatment.
Ongoing treatment with chronic immunosuppressants.
Active CNS lymphoma.
Known gastrointestinal condition that would interfere with swallowing or the oral absorption or tolerance of fimepinostat.
Serious infection requiring systemic antibiotic therapy within 14 days prior to study treatment.
Uncontrolled or severe cardiovascular disease
Unstable or clinically significant concurrent medical condition.
Second primary malignancy within 2 years of study entry other than what is specified in the protocol.
Known HIV positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
Active CMV infection, presence of CMV antigenemia, or evidence of any invasive CMV end organ disease (e.g., CMV colitis).
Clareo Health | Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma
