PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma

Last updated: May 9, 2020
Sponsor: Mingzhi Zhang
Overall Status: Active - Recruiting

Phase

4

Condition

Lymphoma

Non-hodgkin's Lymphoma

T-cell Lymphoma

Treatment

N/A

Clinical Study ID

NCT04040491
hnslblzlzx20190702
  • Ages 14-65
  • All Genders

Study Summary

To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤3;expected survival≥3months

  • patients with Peripheral T-cell Lymphoma diagnosed by immuno-histochemistry (IHC);

  • acceptable hematological indicators, no chemotherapy contraindications;

  • total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x upper age limit (ULN), if the abnormal laboratory parameters areconsidered to be caused by lymphoma, patients Eligible conditions should be adjustedto be incorporated into the group;

  • At least one measurable lesion by CT or PET-CT(Positron Emission Tomography-ComputedTomography);

  • exclude other major diseases, normal heart and lung function;

  • Female patients of childbearing age are negative for pregnancy test;

  • Cooperate with follow-up;

  • There are no other related treatments including traditional Chinese medicine,immunotherapy, and biologic therapy (except for the treatment of anti-bone metastasesand other symptoms);

  • Signing informed consent *: Pathological histology must be consulted by a pathologistat a provincial hospital.

Exclusion

Exclusion Criteria:

  • Patients with ALK-positive Anaplastic Large Cell Lymphoma or angioimmunoblastic T-celllymphoma

  • rejecting providing blood preparation;

  • allergic to drug in this study and with metabolic block;

  • rejecting adopting reliable contraceptive method in pregnancy or lactation period;

  • uncontrolled internal medicine disease(including uncontrolled diabetes,severeincompetence cardiac, lung, liver and pancreas);

  • with severe infection;

  • with primary or secondary central nervous system tumor invasion;

  • with immunotherapy or radiotherapy contraindication;

  • ever suffered with malignant tumor;

  • having peripheral nervous system disorder or dysphrenia;

  • with no legal capacity,medical or ethical reasons affecting research proceeding;

  • participating other clinical trials simultaneously;

  • adopting other anti-tumor medicine excluding this research;

  • Patients with immunodeficiency, such as primary immunodeficiency syndrome or organtransplant recipients

  • Human immunodeficiency virus (HIV)-positive patients

  • the researchers considering it inappropriate to participate in the study.

  • Patients with immune system diseases

Study Design

Total Participants: 100
Study Start date:
September 01, 2019
Estimated Completion Date:
September 01, 2021

Study Description

Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. The investigators have been proceeding this trial to evaluate the efficacy and safety of the PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.

Connect with a study center

  • Oncology Department of The First Affilliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

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