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COPGEM (Copanlisib and Gemcitabine)chemotherapy regimen is proposed as the salvage treatment for relapsed or refractory peripheral T-cell or NK/T-cell lymphomas in this study protocol, which would be expected to be feasible and effective in this group of patients.
Copanlisib (BAY 80-6946), a highly selective and potent class-1 PI3K inhibitor with sub-nanomolar IC50s against PI3Kα and PI3Kδ, has demonstrated activity in relapsed/refractory, aggressive NHLs, suggesting an ORR of 50% for T-cell lymphomas.
Gemcitabine has demonstrated clinical antitumor activity against PTCLs including NK/T-cell lymphomas both as single-agent (ORR 30-50%) and in combination therapy, with limited extramedullary toxicities.
Considering the evidence of activity for both agents against PTCLs, the investigators propose that targeted therapy with copanlisib in combination with gemcitabine will exhibit early elimination of rapidly growing tumor cells and be a rational therapeutic modality for use in relapsed or refractory PTCLs, if the overlapping toxicities can be managed.
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Inclusion criteria
Histologically confirmed relapsed or refractory PTCL or NK/T-cell lymphomas, excluding primary cutaneous T-cell lymphoma, and Sezary syndrome based on WHO classification,
Age ≥ 19
ECOG performance status ≤ 2
at least one bi-dimensional measurable lesion
Laboratory values
Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal for the institution
Women of childbearing potential and men must agree to use adequate contraception when sexually active
Written informed consent
Exclusion criteria
B-cell NHL, or primary cutaneous T-cell lymphoma and Sezary syndrome
Patients who had previous history of lymphoma involvement of the CNS.
History of previous gemcitabine therapy
Type I or II diabetes mellitus with HbA1c > 8.5% at screening
History of chronic hepatitis B; subjects positive for HBsAg will be excluded from this study. However, subjects with HBcAb will be eligible if they are negative for HBV DNA quantification
History of chronic hepatitis C; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA quantification
Known history of human immunodeficiency virus (HIV) infection
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
Any other malignancies within the past 3 years except curatively treated basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, or papillary carcinoma of the thyroid
Other serious illness or medical conditions
Other previous or concurrent treatments
Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Concomitant administration of any other experimental drugs under investigation
Primary purpose
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Interventional model
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28 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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