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Compares treatment options for Peripheral T-Cell Lymphoma, Not Otherwise Specified
Official title Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
ClinicalTrials.gov ID: NCT06561048
What this study is testing
What is Soquelitinib?
Soquelitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for peripheral t-cell lymphoma, not otherwise specified.
Also referred to as CPI-818.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult participants ≥18 years of age on the day of signing the informed consent form.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
- Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic...
- Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the...
You likely can't join if
- Participants who have T-cell lymphoma with active central nervous system involvement.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- History of primary immunodeficiency or sold organ transplantation.
- History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.
- Any active infection requiring IV therapy.
- History of invasive prior malignancy that required systemic therapy within last 3 years.
See the full eligibility criteria
- Adult participants ≥18 years of age on the day of signing the informed consent form.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
- 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.
- 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.
- Life expectancy \>12 weeks.
- Adequate organ function as determined by:
- Absolute neutrophil count ≥ 1.0×10\^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor)
- Platelet count ≥ 100×10\^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...
- 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
- Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:
- Grade ≤ 2 neuropathy
- Alopecia and non-acute toxicities
- If major received major surgery, then must have recovered adequately per the investigator from the toxicity and/or complications from the intervention prior to starting study treatment
- 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...
- 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.
- Participants who have T-cell lymphoma with active central nervous system involvement.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- History of primary immunodeficiency or sold organ transplantation.
- History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.
- Any active infection requiring IV therapy.
- History of invasive prior malignancy that required systemic therapy within last 3 years.
- Any condition that confounds the ability to interpret data from the study.
- 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.
- 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.
- Prior administration of an ITK inhibitor.
- Participants who need immediate cytoreductive therapy.
- Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.
- History of allogeneic hematopoietic stem cell transplantation.
- Candidate for hematopoietic stem cell transplantation at screening.
- History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.
- Concurrent enrollment in another clinical study
- 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.
- Participants who cannot ingest medications orally or who have malabsorption.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
- Darlinghurst, New South Wales, Australia
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States; Miami, Florida, United States; Atlanta, Georgia, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.