Peripheral T-cell Lymphoma
Conditions
Keywords
PD-1, chidamide, lenalidomide, gemcitabine, Peripheral T-cell Lymphoma
Brief 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.
Detailed 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.
Interventions
DRUGPD-1 blocking antibody, chidamide, lenalidomide and gemcitabine
PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Gemcitabine is a cytosine nucleoside derivative, its main metabolite incorporates into DNA in cells and mainly acts on G1 / S phase.
Sponsors
Mingzhi Zhang
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
50 patients for newly diagnosed group and 50 patients for relapse/refractory group.
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤3;expected survival≥3 months * 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 are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group; * At least one measurable lesion by CT or PET-CT（Positron Emission Tomography-Computed Tomography）; * 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 metastases and other symptoms); * Signing informed consent \*: Pathological histology must be consulted by a pathologist at a provincial hospital.
Exclusion criteria
* Patients with ALK-positive Anaplastic Large Cell Lymphoma or angioimmunoblastic T-cell lymphoma * 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,severe incompetence 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 organ transplant recipients * Human immunodeficiency virus (HIV)-positive patients * the researchers considering it inappropriate to participate in the study. * Patients with immune system diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | From date of randomization until the date tumor volume has reduced, assessed up to 36 months | The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation. |
| Progression-free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death |
| Overall Survival | From date of randomization until date of death from any cause, assessed up to 36 months | Time from randomization to death for any reason |
Countries
China
Contacts
Primary ContactMingzhi D Zhang
Outcome results
None listed