Back to resultsPD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
Primary Purpose
Peripheral T-cell Lymphoma
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring PD-1, chidamide, lenalidomide, gemcitabine, Peripheral T-cell Lymphoma
Eligibility Criteria
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
Sites / Locations
- Oncology Department of The First Affilliated Hospital of Zhengzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Newly diagnosed PTCL
Relapse/refractory PTCL
Arm Description
PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.
PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.
Outcomes
Primary Outcome Measures
Overall Response Rate
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
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Overall Survival
Time from randomization to death for any reason
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04040491
Brief Title
PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
Official Title
Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mingzhi Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma
Keywords
PD-1, chidamide, lenalidomide, gemcitabine, Peripheral T-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
50 patients for newly diagnosed group and 50 patients for relapse/refractory group.
Masking
None (Open Label)
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Newly diagnosed PTCL
Arm Type
Experimental
Arm Description
PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.
Arm Title
Relapse/refractory PTCL
Arm Type
Other
Arm Description
PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.
Intervention Type
Drug
Intervention Name(s)
PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
From date of randomization until the date tumor volume has reduced, assessed up to 36 months
Title
Progression-free Survival
Description
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Time Frame
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
Title
Overall Survival
Description
Time from randomization to death for any reason
Time Frame
From date of randomization until date of death from any cause, assessed up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingzhi D Zhang
Phone
+8613838565629
Ext
+8613838565629
Email
Mingzhi_zhang@126.com
Facility Information:
Facility Name
Oncology Department of The First Affilliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang, Pro,Dr
Phone
+8613838565629
Email
Mingzhi_zhang@126.com
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang, Zhang
Phone
+8613838565629
Email
Mingzhi_zhang@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
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