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RecruitingNCT07754890Updated Aug 12, 2026

Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma

A Phase 1/2 interventional study of golidocitinib and Chidamide in Cutaneous T-cell Lymphoma (CTCL), sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Peking Union Medical College Hospital · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2025, registered Dec 2025).
  • Started Aug 2025; still recruiting 1 year 2 months later.

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Phase
Phase 1/2
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Lymphoma, T-Cell, Cutaneous with a site in China — 11 open to participants now, 12 under way, none of them phase 3. Lymphoma, T-Cell, Cutaneous · China.

Planned enrollment
3rd of 13
65 · median 48
Started
2025
with 3 others
Phase 1/2
5 of 15
5 open now
Primary completion
2028-12
later than 10 of 11 live
Registered
13th of 15
by date
Lead sponsor
3 of 15
Peking Union Medical College Hospital

Among the 15 studies in Lymphoma, T-Cell, Cutaneous with a site in China, this one is the 3rd largest by planned enrollment of the 13 interventional ones that give a count, is one of 4 that started in 2025, is one of 5 in phase 1/2, reaches primary completion later than 10 of the 11 other live ones, and was the 13th registered.

Lymphoma, T-Cell, Cutaneous

554 studies on the registry are indexed under Lymphoma, T-Cell, Cutaneous; 63 are open to participants now.

Browse Lymphoma, T-Cell, Cutaneous studies →

Open to participants now

11 of the 15 studies in Lymphoma, T-Cell, Cutaneous with a site in China are open now. Recruiting first, the newest first:

5 more — sign in →

All 11 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 44 Lymphoma, T-Cell, Cutaneous studies recruiting now, 33 (75%) set no upper age limit and 6 (14%) stop at 75 or younger; 5 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Lymphoma, T-Cell, Cutaneous with a site in China, or all of them as a file.
02

Study summary

This is a prospective, single-center phase I/II study, with the purpose of evaluating the efficiency of golidocitinib combined with chidamide in patients with systemically-treated cutaneous T-cell lymphoma. The primary endpoint of the phase I study was to determine the recommended phase II dose (RP2D), while the primary endpoint of the phase II study was the objective response rate (ORR). Secondary endpoints included the complete response (CR) rate, progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety profile.

Read the detailed description

of golidocitinib in combination with chidamide and to determine the recommended phase II dose (RP2D). The study follows a standard "3+3" design. The starting dose of golidocitinib is 150 mg every other day, with pre-specified dose levels including 150 mg every other day and 150 mg once daily. Chidamide is administered at a fixed dose of 20 mg twice weekly. In the phase II segment (dose expansion phase), all participants will receive the combination therapy of golidocitinib and chidamide. Golidocitinib will be administered at the RP2D established in the phase I study, while chidamide will continue at the fixed dose of 20 mg twice weekly. Each treatment cycle is defined as 4 weeks. Tumor response will be assessed every 3 treatment cycles, and safety evaluations will be performed every cycle.

03

Conditions studied

  • Cutaneous T-cell Lymphoma (CTCL)

Keywords

  • cutaneous T-cell lymphoma
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histopathologically confirmed cutaneous T-cell lymphoma.
  • Patients with , with or without extracutaneous lesions, and clinical stage IB-IVB.
  • Disease that has not responded to or has after at least one prior systemic therapy (including, but not limited to, total skin electron beam therapy, bexarotene, retinoids, interferon, extracorporeal photopheresis, methotrexate, or chidamide).
  • An performance status of 0 to 2.
  • Adequate bone marrow function: (ANC) ≥1.5×10⁹/L, count (PLT) ≥80×10⁹/L, (HGB) ≥90 g/L.
  • Adequate organ function: Cardiac function Class 1-2 (), (LVEF) ≥50%, (ALT) \< 2.5 × (ULN), Total (TBil) \< 1.5 × ULN, Oxygen Saturation (SpO₂) > 93% on Room Air, estimated (eGFR) based on serum creatinine (sCr) > 60 mL/min/1.73m².

Exclusion criteria

Exclusion Criteria:

  • Acute myocardial infarction, unstable angina, congestive heart failure, symptomatic arrhythmia within the past 6 months, or significant prolongation (corrected QT interval >450 ms in males or >470 ms in females).
  • Uncontrolled active infection.
  • Active tuberculosis infection.
  • Active (HBV DNA > 1×10³ copies/mL) or (HCV RNA > 1×10³ copies/mL) infection.
  • Pregnancy or lactation.
  • Any other condition deemed by the investigator as unsuitable for participation in this study.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    Golidocitinib and Chidamide

    The phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study. Chidamide is administered at a fixed dose of 20 mg twice weekly.

    Drug: golidocitinib · Drug: Chidamide

Interventions

  • The phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study.

  • Chidamide is administered at a fixed dose of 20 mg twice weekly.

06

What researchers measure

Primary outcomes

  1. Recommended Phase II Dose (RP2D)

    The RP2D is determined based on the occurrence of dose-limiting toxicities (DLTs) during the first cycle (28 days) of treatment. It is defined as the highest dose level at which fewer than 33% of participants experience a DLT.

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR).

    Time frame: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause

Secondary outcomes

  1. Complete Response (CR) Rate

    Proportion of participants achieving a complete response (CR)

    Time frame: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause

  2. Progression-Free Survival (PFS)

    the time from the first dose of study drug to the first documented disease progression or death

    Time frame: From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause

  3. Overall Survival (OS)

    the time from the first dose of study drug to death from any cause

    Time frame: From enrollment to the end of 2-year follow-up phase or death from any cause

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Dec 2028, 40 months after the start.

Of 16 phase 1/2 interventional studies under Lymphoma, T-Cell, Cutaneous, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 88. This study's planned 40 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2025
First posted
Aug 10, 2026
StartActual
Aug 26, 2025
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2030
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07754890
Responsible party
Wei Zhang (Prof., Peking Union Medical College Hospital) — Principal investigator
First posted
Aug 10, 2026
Start date
Aug 26, 2025
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Aug 12, 2026

Study contacts

Wei Zhang
Contact
vv1223@vip.sina.com
13681473557

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Golidocitinib · Tucidinostat

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