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New treatment option for Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)
Official title A Phase I/II Study of Golidocitinib Combined with Pomalidomide in R/R PTCL
ClinicalTrials.gov ID: NCT06855823
What this study is testing
What is Golicitinib combined with Pomadomide?
Golicitinib combined with Pomadomide is an investigational medicine, being studied as a potential treatment for relapsed/refractory peripheral t-cell lymphoma (r/r ptcl).
Also referred to as Golidocitinib: JAK1 Inhibitor, Pomalidomide: Third-generation Immunomodulatory Drug (IMiD).
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
- This is a phase I/II clinical trial to evaluate the efficacy and safety of Golidocitinib combined with Pomalidomide for relapsed/refractory peripheral T-cell lymphoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients must demonstrate a comprehensive understanding of the study protocol, voluntarily consent to participation, and execute the informed consent...
- Inclusive of both genders, participants must be aged 18 years or older and not exceed 80 years of age.
- Histopathological confirmation of peripheral T-cell lymphoma (PTCL) must adhere to the World Health Organization (WHO) 2016 classification criteria...
- people must exhibit relapsed or refractory disease following prior systemic therapy, which may include autologous hematopoietic stem cell...
- At least one lesion must be present that is evaluable or measurable according to the Lugano2014 criteria: for lymph node lesions, the minimum...
You likely can't join if
- Presence of hemophagocytic syndrome.
- Involvement of the central nervous system or meninges by lymphoma.
- A history of malignant tumors within the past five years, with the exception of locally curable tumors that have been subjected to radical treatment...
- History of any of the following treatments:(1) Allogeneic hematopoietic stem cell transplantation prior to the administration of the investigational...
- Active infections, including: (1) Known active/latent tuberculosis, including a positive tuberculin skin test or findings on plain chest X-ray/CT...
- Active autoimmune diseases requiring systemic treatment within the past two years (hormone replacement therapy not considered systemic treatment...
See the full eligibility criteria
- Patients must demonstrate a comprehensive understanding of the study protocol, voluntarily consent to participation, and execute the informed consent document.
- Inclusive of both genders, participants must be aged 18 years or older and not exceed 80 years of age.
- Histopathological confirmation of peripheral T-cell lymphoma (PTCL) must adhere to the World Health Organization (WHO) 2016 classification criteria. This encompasses a range of PTCL subtypes, including but not limited...
- people must exhibit relapsed or refractory disease following prior systemic therapy, which may include autologous hematopoietic stem cell transplantation. Relapse is characterized by disease recurrence post-complete...
- At least one lesion must be present that is evaluable or measurable according to the Lugano2014 criteria: for lymph node lesions, the minimum measurable length is 1.5cm; for non-lymph node lesions, extra-nodal lesions...
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score ranging from 0 to 2.
- Laboratory parameters must meet the following criteria: (1) absolute neutrophil count (ANC) of at least 1.5×10\^9/L; (2) platelet count (PLT) of at least 75×10\^9/L (with a minimum of 50×10\^9/L for patients with bone...
- Participants must not have undergone radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation within the 3 weeks preceding study enrollment.
- Investigators must assess that the subject has a life expectancy of at least six months.
- Presence of hemophagocytic syndrome.
- Involvement of the central nervous system or meninges by lymphoma.
- A history of malignant tumors within the past five years, with the exception of locally curable tumors that have been subjected to radical treatment (e.g., basal or squamous cell carcinoma of the skin, superficial...
- History of any of the following treatments:(1) Allogeneic hematopoietic stem cell transplantation prior to the administration of the investigational drug; (2) Autologous hematopoietic stem cell transplantation within...
- Active infections, including: (1) Known active/latent tuberculosis, including a positive tuberculin skin test or findings on plain chest X-ray/CT (positive skin test results should exhibit an induration diameter greater...
- Active autoimmune diseases requiring systemic treatment within the past two years (hormone replacement therapy not considered systemic treatment, such as type I diabetes, hypothyroidism managed with thyroxine...
- Uncontrolled cardiac clinical symptoms or diseases, such as: i. New York Heart Association (NYHA) class \> 2 heart failure ii. Unstable angina pectoris iii. Myocardial infarction within one year iv. Patients with...
- Prior interstitial lung disease (except for asymptomatic interstitial lung disease induced by radiotherapy).
- Presence of unresolved adverse drug reactions greater than CTCAE grade 1 (excluding alopecia) before study initiation.
- Patients with hypersensitivity to golidocitinib or pomalidomide/capsule excipients or other chemical analogs; patients with a known history of severe allergic reactions to monoclonal antibodies (CTCAE≥3) and...
- people requiring supportive treatment for refractory nausea, vomiting, chronic gastrointestinal disorders, dysphagia, or prior surgical removal of intestinal segments that may impede adequate drug absorption.
- Pregnant and lactating women and individuals of childbearing age who are unwilling to practice contraceptive measures.
- Individuals with psychiatric illnesses or those incapable of providing informed consent.
- Deemed ineligible for study participation by the researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. 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.