Recruiting PHASE3 Peripheral T-cell Lymphoma

Compares treatment options for Peripheral T-cell Lymphoma

Official title A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

ClinicalTrials.gov ID: NCT07234162

What this study is testing

What is Golidocitinib?

Golidocitinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for peripheral t-cell lymphoma.

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 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen(s).
  • 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

  • The participants should sign the ICF and be able to comply with the relevant requirements in the ICF and protocol
  • Age ≥ 18 years
  • ECOG 0-2 score, life expectancy ≥ 12 weeks
  • Patients must have histologically confirmed peripheral T-cell lymphoma according to the World Health Organization classification of lymphoma. Eligible...
  • Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator

You likely can't join if

  • Any of previous or current treatment prohibited by protocol
  • Any unresolved \> grade 2 drug-related adverse events
  • Lymphoma involving central nervous system
  • Any of severe cardiac or pulmonary abnormalities
  • Disease condition requires immunosuppressants, biologics, or NSAIDs
  • Active infection
See the full eligibility criteria
Who can join
  • The participants should sign the ICF and be able to comply with the relevant requirements in the ICF and protocol
  • Age ≥ 18 years
  • ECOG 0-2 score, life expectancy ≥ 12 weeks
  • Patients must have histologically confirmed peripheral T-cell lymphoma according to the World Health Organization classification of lymphoma. Eligible subtypes are restricted to: PTCL-not otherwise specified, NOS (PTCL...
  • Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator
  • Adequate bone marrow reserve and organ system functions
  • Willing to comply with contraceptive restrictions
What rules you out
  • Any of previous or current treatment prohibited by protocol
  • Any unresolved \> grade 2 drug-related adverse events
  • Lymphoma involving central nervous system
  • Any of severe cardiac or pulmonary abnormalities
  • Disease condition requires immunosuppressants, biologics, or NSAIDs
  • Active infection
  • Malignancy disease within five years
  • Poorly controlled gastrointestinal disorder or inadequate absorption of medication
  • Severe or poorly controlled systemic diseases

The study team makes the final eligibility decision.

Where it's taking place

  • Hefei, Anhui, China
  • Beijing, Beijing Municipality, China
  • Chongqing, Chongqing Municipality, China
  • Fuzhou, Fujian, China
  • Xiamen, Fujian, China
  • Lanzhou, Gansu, China
  • Guangzhou, Guangdong, China
  • Nanning, Guangxi, China
  • Harbin, Heilongjiang, China
  • Zhengzhou, Henan, China
  • Wuhan, Hubei, China
  • Changsha, Hunan, China
  • Nanjing, Jiangsu, China
  • Changchun, Jilin, China
  • Shenyang, Liaoning, China
  • Jinan, Shandong, China
  • Linyi, Shandong, China
  • Shanghai, Shanghai Municipality, China
  • Taiyuan, Shanxi, China
  • Xi’an, Shanxi, China

+ 15 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 Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China; Lanzhou, Gansu, China and 29 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.