- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04038411
PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma
July 29, 2019 updated by: Mingzhi Zhang
Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory Natural Killer/T Cell Lymphoma
To observe the safety, tolerability and clinical effects of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, open-label, one-arm, multicenter clinical trial, aimed to evaluate the safety, tolerability, and efficacy of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma.
A total of 50 patients are planned to be enrolled into the study.
The primary end points are objective responder rate (ORR) and progression free survival(PFS) and the secondary end points include overall survival(OS) , and adverse events.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mingzhi D Zhang
- Phone Number: +8613838565629 +8613838565629
- Email: Mingzhi_zhang@126.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450052
- Recruiting
- Oncology Department of The First Affilliated Hospital of Zhengzhou University
-
Contact:
- Mingzhi Zhang, Pro,Dr
- Phone Number: +8613838565629
- Email: Mingzhi_zhang@126.com
-
Contact:
- Mingzhi Zhang, Zhang
- Phone Number: +8613838565629
- Email: Mingzhi_zhang@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months;
- patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH);
- Refractory or relapse after at least 2 regimen;
- Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence;
- No chemotherapy contraindications: hemoglobin ≥ 100g / L, absolute neutrophil count ≥ 1.5 × 109 / L, platelets ≥ 80 × 109 / L, ALT, AST ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal Upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / L;
- At least one measurable lesion;
- There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal;
- Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication;
- There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied;
- Can understand the situation of this study and sign the informed consent voluntarily
Exclusion Criteria:
- rejecting providing blood preparation;
- allergic to drug in this study or with hemophagocytic syndrome;
- 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 Chemotherapy or radiotherapy contraindication;
- ever suffered with malignant tumor;
- Human immunodeficiency virus (HIV)-positive patients
- Drug abuse or long-term alcohol abuse that affects the evaluation of test results;
- Have peripheral nervous system disorder or mental disorder;
- Patients with immune system diseases;
- Those who have no legal capacity or whose research is affected by medical or ethical reasons;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PD-1 Antibody, chidamide, lenalidomide and etoposide
PD-1 Antibody: 240mg, d1, Chidamide: 20mg, twice a week, Lenalidomide: 25mg, d1-14 Etoposide:100mg/m2, d1-3 and 21 days made one treatment cycle.
|
PD-1 blocking antibody inhibits PD-1.
Chidamide is an histone deacetylase inhibitor.
Lenalidomide is a potent inhibitor of TNF-α.
Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: From date of randomization until the date of first 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.
|
From date of randomization until the date of first date tumor volume has reduced, assessed up to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival
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
|
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
|
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
|
Overall Survival
Time Frame: From date of randomization until date of death from any cause, assessed up to 36 months
|
Time from randomization to death for any reason.
|
From date of randomization until date of death from any cause, assessed up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
July 2, 2019
First Submitted That Met QC Criteria
July 29, 2019
First Posted (Actual)
July 30, 2019
Study Record Updates
Last Update Posted (Actual)
July 30, 2019
Last Update Submitted That Met QC Criteria
July 29, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Etoposide
- Antibodies
- Lenalidomide
Other Study ID Numbers
- hnslblzlzx2019070202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on NK/T Cell Lymphoma
-
The Affiliated Hospital of Xuzhou Medical UniversityRecruitingNK-Cell Leukemia | Extranodal NK T Cell LymphomaChina
-
The First Affiliated Hospital with Nanjing Medical...Not yet recruiting
-
Peking UniversityPeking University Cancer Hospital & Institute; Peking University International... and other collaboratorsRecruitingNK/T Cell Lymphoma NosChina
-
Beijing Tongren HospitalNot yet recruitingExtranodal NK/T-cell Lymphoma, Nasal Type
-
Jiangsu HengRui Medicine Co., Ltd.UnknownExtranodal NK/T-cell Lymphoma, Nasal TypeChina
-
Ruijin HospitalCompletedNasal Type Extranodal NK/T-Cell LymphomaChina
-
Cancer Institute and Hospital, Chinese Academy...CompletedStage I/II Extranodal NK/T-cell LymphomaChina
-
Samsung Medical CenterConsortium for Improving Survival of Lymphoma; Lymphoma Study Association; Deok-Hwan... and other collaboratorsCompletedExtranodal NK/T-cell Lymphoma, Nasal TypeKorea, Republic of
-
The First Affiliated Hospital with Nanjing Medical...Not yet recruiting
-
Samsung Medical CenterCompletedExtranodal NK/T Cell LymphomaKorea, Republic of
Clinical Trials on PD-1 Antibody, chidamide, lenalidomide and etoposide
-
Hunan Cancer HospitalRecruitingChemotherapy Effect | NK/T-cell Lymphoma of Nasal Cavity | Immune Checkpoint Inhibitor | Epigenetic DisorderChina
-
Sun Yat-sen UniversityChipscreen Biosciences, Ltd.Not yet recruitingRelapsed or Refractory DLBCL
-
The First Affiliated Hospital with Nanjing Medical...Recruiting
-
Beijing Tongren HospitalNot yet recruitingExtranodal NK/T-cell Lymphoma, Nasal Type
-
Fudan UniversityRecruitingPeripheral T-cell LymphomaChina
-
Mingzhi ZhangUnknownPeripheral T-cell LymphomaChina
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern... and other collaboratorsRecruitingNasopharyngeal Carcinoma | Surgery | PD-1China
-
Tianjin Medical University Cancer Institute and...Jiangsu HengRui Medicine Co., Ltd.Completed
-
Nanjing Leads Biolabs Co.,LtdRecruitingAdvanced Malignant TumorsChina
-
Eye & ENT Hospital of Fudan UniversityNot yet recruitingNasopharyngeal Carcinoma