ClinicalTrials.gg
RecruitingNCT06630091Updated Nov 3, 2026

A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study

A Phase 2 interventional study of Golidocitinib and Cyclophosphamide in Peripheral T Cell Lymphoma, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.

Read the detailed description

Primary Objectives

  • To assess the 2-year progression-free survival rate of golidocitinib as primary efficacy endpoint in participants with newly diagnosed PTCL.

Secondary Objectives

  • To assess the anti-tumor efficacy of golidocitinib using PET/CT-based objective response rate (ORR), complete response rate (CRR), duration of response (DoR), progression-free survival (PFS), and time to response (TTR) assessed according to the 2014 Lugano classification as secondary efficacy endpoint in patients with newly diagnosed PTCL.
  • To assess the safety and tolerability of golidocitinib in participants with newly diagnosed PTCL according to the adverse events graded by CTCAE version 5.0.

Exploratory Objectives

  • To identify participant selection biomarkers derived from tumor and plasma at baseline and correlate these biomarkers with tumor response to golidocitinib.
  • Evaluate potential mechanisms of resistance to golidocitinib in plasma and tumor biopsies of PTCL participants at baseline and upon progression.
02

Conditions studied

  • Peripheral T Cell Lymphoma
03

In context

Lymphoma, T-Cell, Peripheral

372 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 110 are open to participants now.

This study's planned enrollment of 30 is below the median of 44 across 328 interventional studies indexed under Lymphoma, T-Cell, Peripheral.

Browse Lymphoma, T-Cell, Peripheral studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
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

  • Provision of a signed and dated, written form prior to any study specific procedures, sampling, and analyses.
  • Submission of the tumor block or unstained slides from an excisional or core from nodal or extra-nodal lymphoma tissue (archived or newly obtained sample) is required for retrospective central confirmation of tumor histological subtype.
  • Aged ≥ 18 years old.
  • Participants must exhibit (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks.
  • Predicted ≥ 12 weeks.
  • Participants must have confirmed peripheral T-cell lymphoma by MD Anderson pathology review according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms53. Eligible histological subtypes are restricted to the following:

    • PTCL, not otherwise specified (PTCL, NOS) (the proportion of PTCL-NOS subtype will not exceed 30% of all enrolled)
    • Angioimmunoblastic T-cell lymphoma (AITL)
    • Follicular T cell lymphoma
    • PTCL with T follicular helper (TFH) phenotype
  • Participants must have according to the 2014 Lugano classification, which is defined as lymphomatous nodes, nodal masses, or other lymphomatous lesions are measurable in two diameters (longest diameter [LDi] and shortest diameter perpendicular to the LDi [SDi]) on CT scans, and also with LDi as below:

    • A measurable node must have an LDi greater than 1.5 cm.
    • A measurable extranodal lesion should have an LDi greater than 1.0 cm.
  • Participants must be treatment naïve with no prior systemic treatment for T-cell lymphoma (i.e., PTCL). Participants could be transplant eligible or ineligible upon their entries to this study.
  • Adequate bone marrow reserve and organ system functions, as outlined below:

    • (ANC) ≥ 1 ×109/L (≥0.5 ×109/L if documented bone marrow involvement with lymphoma) independent of growth factor support within 7 days of study entry.
    • ≥ 75 × 109/L (or ≥ 50 × 109/L if documented bone marrow involvement with lymphoma) independent of growth factor support or transfusion within 7 days of study entry.
    • ≥ 8 g/dL
    • Total ≤ 1.5 × if no liver involvement or ≤ 3 ×ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver involvement.
    • (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 ×ULN if with document hepatic involvement with lymphoma.
    • Creatinine ≤ 1.5 × ULN, OR calculated or measured ≥ 50 mL/min as calculated by the Cockcroft-Gault method, or 24-hour measured urine creatinine clearance ≥ 50 mL/min.
  • ≥ 50% assessed by ECHO or MUGA.
  • Participants should have the ability and willingness to comply with the study and follow up.
  • The effects of golidocitinib on the developing human fetus are unknown. For this reason and because JAK1 inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of and men must agree to use adequate (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following:

    • (no menses in greater than or equal to 12 consecutive months).
    • History of hysterectomy or bilateral salpingo-oophorectomy.
    • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
    • History of bilateral tubal ligation or another surgical sterilization procedure.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Women treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of golidocitinib administration. If female patients wish to mother children, they should be advised to arrange for freezing of eggs prior to the start of study treatment.
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of golidocitinib administration. Men must refrain from donating sperm during their participation in the study and at least for 6 months after the last treatment. If male patients wish to father children, they should be advised to arrange for freezing of sperm samples prior to the start of study treatment.

Exclusion criteria

Exclusion Criteria:

Participants must not enter the study if any of the following exclusion criteria are fulfilled:

  • Intervention with any of the following:

    • Any anti-cancer agents or anti-cancer study drugs from a previous clinical study.
    • Any cytotoxic chemotherapy from a previous treatment regimen.
    • at dosages equivalent to prednisone > 40 mg/day within 7 days of the start of the study treatment.
    • Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.
    • Prior treatment with a JAK or STAT3 inhibitor.
    • Prior treatment with any onco-immunotherapy in 28 days prior to first dosing of golidocitinib (e.g., PD-1, PD-L1, CTLA4).
    • within 28 days prior to first dose.
    • Participants currently receiving (or unable to stop use at least 1 week prior to receiving the first dose) medications or herbal supplements known to be Potent inhibitors or inducers of .
  • Central nervous system or lymphoma given the lack of evidence of CNS penetrance of the investigational drug.
  • Participants with severely decreased lung function (i.e. any parameter of , and DLCO \< 60% of predicted value). Past medical history of pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
  • Participants with disease condition which requires the treatment of , biologics, or NSAIDs (non-steroid anti-inflammatory drugs).
  • Active infections including

    • History of known active tuberculosis (TB).
    • Known infection with (HIV).
    • Known active or infection as follows
  • Active viral infections (i.e., zoster) other than hepatitis B or C.

    o Infections requiring oral or intravenous antimicrobial therapy or interferon within 14 days.

  • Any of the following cardiac criteria:

    • Congestive heart failure (CHF) per (NYHA) classification > Class II .
    • valvular diseases, hypertrophic or constrictive cardiomyopathy.
    • Any clinically significant abnormalities in rhythm, conduction or morphology of resting , e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval > 250 msec.
    • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
    • Acute Myocardial Infarction (AMI) within 6 months prior to starting treatment, unstable angina or new-onset angina.
    • Participants with heart transplant.
    • Mean resting corrected interval >450 ms on screening electrocardiogram (ECG).
    • Participants with factors that increase the risk of QT prolongation or arrhythmic events (e.g., congenital long QT syndrome, any concomitant medication known to prolong the QT interval or family history of long QT interval syndrome or unexplained sudden death under 40 years of age in first degree relatives).
    • Participants with acute thrombotic diseases such as pulmonary embolism (PE) and deep venous thrombosis (DVT) within 90 days. Participants with remote history (>6 months) of provoked PE or DVT (e.g., line-associated DVT; DVT or PE after surgical procedure), and participants on appropriate anticoagulation for 90 or more days from the event will not be excluded.
  • Another within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
  • nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of golidocitinib.
  • History of to active or inactive of golidocitinib or drugs with a similar chemical structure or class.
  • As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses. Screening for chronic conditions is not required.
  • Concurrent conditions that in the investigator's opinion would jeopardize compliance with the protocol.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • All participants must avoid concomitant use of medications, herbal supplements and/or ingestions of foods with known potent inducer/inhibitory effects on CYP3A activity whenever feasible. Such drugs must have been discontinued for an appropriate period before they enter screening and for a period after the last dose of golidocitinib. Guidance on medications to avoid, medications that require close monitoring and on .
  • Participants with psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because golidocitinib is a JAK1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with golidocitinib, breastfeeding should be discontinued if the mother is treated with golidocitinib. These potential risks may also apply to other agents used in this study.
Terms in these criteria, in plain language(37)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

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.

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).

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.

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.

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.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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.

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

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

Study arms

  • Experimental
    Golidocitinib + CHOP

    Golidocitinib will be administered at 150 mg PO daily as monotherapy unless dose modified per toxicity chart; when in combination with CHOP, the maximum dose of golidocitinib is 150 mg PO every other day

    Drug: Golidocitinib · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone

Interventions

06

What researchers measure

Primary outcomes

  1. Safety and Adverse Events

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

    Time frame: Through study completion; an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Updates

2 registry updates since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
2 updates, last Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    Minor edits only
    + 1 other change: verification date
  2. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06630091
Responsible party
Sponsor
First posted
Oct 8, 2024
Start date
Feb 21, 2025
Primary completion
Jul 5, 2027 (estimated)
Completion
Jul 5, 2029 (estimated)
Last update
Nov 3, 2026

Study contacts

Luis Malpica Castillo, MD
Contact
lemalpica@mdanderson.org
713-563-8954
Luis Malpica Castillo, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Golidocitinib

Start the discussion