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Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)

ConditionRelapsed or Refractory Peripheral T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-75
SponsorGreat Novel Therapeutics Biotech & Medicals Corporation

About this trial

This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histopathological diagnosis, made by the investigator, of the following PTCL subtypes as defined by the WHO classification (2016) may be included: PTCL, not otherwise specified (PTCL-NOS), anaplastic lymphoma kinase-positive (ALK+) anaplastic large-cell lymphoma (ALCL), ALK-negative (ALK-) ALCL, angioimmunoblastic T-cell lymphoma (AITL), extranodal natural killer (NK)/T-cell lymphoma, nasal type (ENKL), etc., except cutaneous form or leukemic form.

Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline.

Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 prior systemic therapy including, but not limited to, chemotherapy, target therapy, immunotherapy, and autologous stem cell transplantation.

Male or female, aged 20-75 years (inclusive).

Disqualifiers

Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception.

Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm).

Have been treated with histone deacetylase (HDAC) inhibitor.

With a history of clinically significant QTc prolongation (>450 ms for males or >470 ms for females), ventricular tachycardia (VT), atrial fibrillation (AF), heart block (HB), myocardial infarction (MI) onset within one year, congestive heart failure (CHF), or any other symptomatic coronary artery disease requiring treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Chidamide

    Drug

    Subjects will receive a single dose of 30 mg chidamide. Twice a week.

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: ChidamideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Overall Efficacy Review Committee (IOERC) assessment of response.

Time frame
24 months

Secondary outcomes

1

Time to response (TTR)

Time to response was defined as the time (in weeks) from first administration of treatment until first response. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.

Time frame
24 months
2

Duration of response (DOR)

The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.

Time frame
24 months
3

Progression-free survival (PFS)

Progression-free survival (PFS) was the duration of time from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.

Time frame
24 months
4

Overall survival (OS)

Overall Survival was the time from first administration of study treatment until the date of death.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Great Novel Therapeutics Biotech & Medicals Corporation

Lead sponsor

Source ClinicalTrials.gov
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