OncoTrials - мониторинг клинических исследований

Описание

A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician`s choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).

Критерии включения

• 1. Adult participants ≥18 years of age on the day of signing the informed consent form.
• 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
• 3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
• 4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.
• 5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist.
• 6. Life expectancy />12 weeks.
• 7. Adequate organ function as determined by:
• * Absolute neutrophil count ≥ 1.0×10/^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor)
• * Platelet count ≥ 50×10/^9/L (without transfusion)
• * Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug
• * Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants
• * Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute
• * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels /> 1.5 × ULN. For participants with Gilbert`s disease: ≤ 3.0 mg/dL or discussion with the Medical Monitor
• * Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
• * Serum albumin /> 2.5 g/dL
• * Serum calcium /< 12 mg/dL or corrected serum calcium /< ULN
• 8. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate.
• 9. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.

Критерии исключения

• 1. Participants who have T-cell lymphoma with active central nervous system involvement.
• 2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
• 3. Any condition that confounds the ability to interpret data from the study.
• 4. Any active infection requiring IV therapy.
• 5. History of invasive prior malignancy that required systemic therapy within last 3 years.
• 6. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen /[HBsAg/]) or positive test for hepatitis C antibody.
• 7. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.
• 8. History of allogeneic hematopoietic stem cell transplantation.
• 9. Candidate for hematopoietic stem cell transplantation at screening.
• 10. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.
• 11. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.

Описание

This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed/Refractory non-Hodgkin`s lymphoma to determine if ARV-393 may be a possible treatment option.

ARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.

Критерии включения

• * Eligible participants aged ≥18 years.
• * Have relapsed/refractory mature B-cell non-Hodgkin lymphoma (NHL) and ≥2 prior systemic therapies, or histologically confirmed AITL that has recurred or progressed following institutional standard-of-care therapy.
• * Participants must also have ≥1 measurable lesion at study entry
• * Eastern Cooperative Oncology Group performance status of 0 or 1,
• * Freshly biopsied or archival tumor tissue available,
• * Participants with adequate organ function,
• * Participants must accept and follow pregnancy prevention guidance.

Критерии исключения

• * No prior allogeneic stem cell transplant or solid organ transplantation, Autologous stem cell transplant, must not have occurred ≤100 days, previous CAR T-cell therapy ≤60 days, radiotherapy ≤ 2 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, prior to ARV-393 treatment initiation.
• * Participants must not have significant acute or chronic medical illness, including hypereosinophilic syndrome, active interstitial lung disease or pneumonitis, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
• * Participants with an inability to comply with listed prohibited treatments.