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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06630091
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Peripheral T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golidocitinib — DRUG
    150 mg once per day by PO
  • Cyclophosphamide — DRUG
    750 mg/m2 by IV
  • Doxorubicin — DRUG
    50 mg/m2 by IV
  • Vincristine — DRUG
    1.4 mg/m2 (max: 2 mg) by IV
  • Prednisone — DRUG
    100 mg by PO

Study Details

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.

Key Dates

Start date
Feb 21, 2025
Status verified
Feb 2026
Primary completion
Jul 5, 2027
Completion
Jul 5, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

Safety and Adverse Events [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Luis o, MD
[email protected]
713-563-8954
Luis Malpica Castillo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX

Related Studies