Copanlisib and Gemcitabine in Relapsed/Refractory PTCL (NCT03052933) | Clinical Trial Compass
CompletedPhase 1/2
Copanlisib and Gemcitabine in Relapsed/Refractory PTCL
South Korea28 participantsStarted 2018-02-01
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Serum Cr \< 1.5 mg/dL or CrCl \> 50 mL/min
* Transaminase (AST/ALT) \< 2.5 x ULN (or \< 5 x ULN in the presence of lymphoma involvement of the liver)
* Bilirubin \< 1.5 x UNL ( or \< 3 x ULN in the presence of lymphoma involvement of the liver or Gilbert syndrome)
* PT (INR) ≤ 1.5 x ULN and aPTT ≤ 1.5 x ULN
* Lipase ≤ 1.5 x ULN
* Hematologic functions: absolute neutrophil count (ANC) ≥ 1,500/µL and platelet count ≥ 75,000/µL, hemoglobin ≥ 8 g/dL
* 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 posi…
What they're measuring
1
Dose limiting toxicity (DLT), Maximum tolerated dose (MTD) for phase I