RECRUITING

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

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Conditions

Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell LymphomaFollicular T-Cell LymphomaNodal Peripheral T-Cell Lymphoma With TFH PhenotypeSystemic Anaplastic Large Cell LymphomaLymphoma, T-Cell, PeripheralLymphoma, T-CellPeripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL-NOS)Follicular Helper T-Cell Lymphoma (FHTCL)Angioimmunoblastic T-cell Lymphoma (AITL)Follicular T-Cell Lymphoma (FTCL)Nodal Peripheral T-Cell Lymphoma with T Follicular Helper Phenotype (PTCL-Tfh)Systemic Anaplastic Large Cell Lymphoma (sALCL)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Quick Facts

Study Start:2024-10-02
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06561048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult participants ≥18 years of age on the day of signing the informed consent form.
  2. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  3. 3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.
  4. 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. 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. 6. Life expectancy \>12 weeks.
  7. 7. Adequate organ function as determined by:
  8. * Absolute neutrophil count ≥ 1.0×10\^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor)
  9. * Platelet count ≥ 50×10\^9/L (without transfusion)
  10. * Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug
  11. * 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
  12. * Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute
  13. * 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
  14. * Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
  15. * Serum albumin \> 2.5 g/dL
  16. * Serum calcium \< 12 mg/dL or corrected serum calcium \< ULN
  17. 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.
  18. 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.
  1. 1. Participants who have T-cell lymphoma with active central nervous system involvement.
  2. 2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  3. 3. Any condition that confounds the ability to interpret data from the study.
  4. 4. Any active infection requiring IV therapy.
  5. 5. History of invasive prior malignancy that required systemic therapy within last 3 years.
  6. 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. 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. 8. History of allogeneic hematopoietic stem cell transplantation.
  9. 9. Candidate for hematopoietic stem cell transplantation at screening.
  10. 10. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.
  11. 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.

Contacts and Locations

Study Contact

Study Director
CONTACT
650-900-4520
clinicaltrials@corvuspharma.com

Principal Investigator

Suresh Mahabhashyam, MD, MPH
STUDY_DIRECTOR
Corvus Pharmaceuticals, Inc.

Study Locations (Sites)

Corvus Clinical Trials Information
Burlingame, California, 94010
United States

Collaborators and Investigators

Sponsor: Corvus Pharmaceuticals, Inc.

  • Suresh Mahabhashyam, MD, MPH, STUDY_DIRECTOR, Corvus Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-02
Study Completion Date2027-09

Study Record Updates

Study Start Date2024-10-02
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Peripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL-NOS)
  • Follicular Helper T-Cell Lymphoma (FHTCL)
  • Angioimmunoblastic T-cell Lymphoma (AITL)
  • Follicular T-Cell Lymphoma (FTCL)
  • Nodal Peripheral T-Cell Lymphoma with T Follicular Helper Phenotype (PTCL-Tfh)
  • Systemic Anaplastic Large Cell Lymphoma (sALCL)

Additional Relevant MeSH Terms

  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Angioimmunoblastic T-cell Lymphoma
  • Follicular T-Cell Lymphoma
  • Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
  • Systemic Anaplastic Large Cell Lymphoma
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, T-Cell