Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypePhase 2NCT03107962
Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma
A Phase 2 study testing Pembrolizumab (PD-1 Blocking Antibody) in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Mingzhi Zhang at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of PD-1 blockade pembrolizumab for patients with relapsed or refractory Natural Killer(NK)/T Cell Lymphoma. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
- What is being tested?
- Pembrolizumab (PD-1 Blocking Antibody)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2017to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
- Histological confirmed evidence of relapsed or refractory NK/T cell lymphoma
- Before enrollment, representative formalin-fixed paraffin-embedded tumor samples (or 15 tissue sections at least) and related pathological reports are needed
- Previous treatment with at least one chemotherapy regimen
- At least one measurable lesion
- None of other serious diseases, cardiopulmonary function is normal
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- Pregnancy test of women at reproductive age must be negative
- Patients could be followed up
- None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- volunteers who signed informed consent.
- No anti-PD1 antibody contraindication (All of the following tests are required to be finished within 14 days prior to the first research): 2.5×109/L<WBC<15×109/L, hemoglobin ≥ 90 g/L, neutrophil≥ 1.5×109/L, lymphocyte≥0.5×109/L, platelet ≥ 100×109/L, serum albumin≥2.5g/dL, ALT and AST ≤ 2×ULN, serum bilirubin≤ 1.5×ULN, serum creatine ≤ 1.5×ULN, Serum Albumin ≥ 30g/L, serum plasminogen is normal, creatinine clearance rate≥30 mL/min, INR≤1.5×ULN, APTT≤1.5×ULN
Who cannot join
- Disagreement on blood sample collection
- Patients allergic of chimeric or humanized antibody
- Pregnant or lactating women
- Serious medical illness likely to interfere with participation
- Serious infection
- Primitive or secondary tumors of central nervous system
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- The evidence of CNS metastasis
- History of peripheral nervous disorder or dysphrenia
- History of active autoimmune disease and a concomitant second cancer
- patients participating in other clinical trials
- patients taking other antitumor drugs
- patients estimated to be unsuitable by investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mingzhi Zhang, Pro,Dr, 13838565629, mingzhi_zhang@126.com
About this study
Official title: PD-1 Blockade With Pembrolizumab in Relapsed or Refractory Natural Killer/T Cell Lymphoma
The purpose of this study is to evaluate the efficacy and safety of PD-1 blockade pembrolizumab for patients with relapsed or refractory Natural Killer(NK)/T Cell Lymphoma.
Read the detailed description
Patients with relapsed or refractory NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy. The investigators have been proceeding this trial to evaluate the efficacy and safety of the immune checkpoint inhibitor PD-1 blockade, pembrolizumab in the patients with relapsed or refractory NK/T cell lymphoma.
- Being tested
- Pembrolizumab (PD-1 Blocking Antibody)
- Keywords
- NK/T cell lymphoma, immunotherapy, clinical trial, RR, PFS, OS
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab (PD-1 Blocking Antibody)Drug
Also called Pembrolizumab
pembrolizumab 2mg/kg, ivgtt (intravenously guttae), d1. Every three weeks for one cycle and two cycles are required at least. Efficacy and safety were evaluated every two cycles.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 Blocking Antibody | Experimental | Pembrolizumab Receives: Drug: Pembrolizumab (PD-1 Blocking Antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles.
Measured: every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug)
Secondary outcomes (3)
Progression-free survival
Progression-free survival
Measured: up to end of follow-up-phase (approximately 24 months)
Overall survival
Overall survival
Measured: up to the date of death (approximately 3 years)
Median survival time
Median survival time
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start19 Feb 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingzhi Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingzhi Zhang, Zhengzhou University
- Investigators
- Mingzhi Zhang, Pro,Dr, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107962
- Sponsor's protocol ID
- hnslblzlzx2017
- Status last verified
- Apr 2017
- First submitted
- 20 Mar 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Blockade With Pembrolizumab in Relapsed or Refractory Natural Killer/T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03107962
- Acronym / sponsor ID
- hnslblzlzx2017
- Keywords
- NK/T cell lymphoma, immunotherapy, clinical trial, RR, PFS, OS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Study start
- 19 Feb 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of PD-1 blockade pembrolizumab for patients with relapsed or refractory Natural Killer(NK)/T Cell Lymphoma.
Detailed description
Patients with relapsed or refractory NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy. The investigators have been proceeding this trial to evaluate the efficacy and safety of the immune checkpoint inhibitor PD-1 blockade, pembrolizumab in the patients with relapsed or refractory NK/T cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 Blocking Antibody | Experimental | Drug: Pembrolizumab (PD-1 Blocking Antibody)Pembrolizumab |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
- Histological confirmed evidence of relapsed or refractory NK/T cell lymphoma
- Before enrollment, representative formalin-fixed paraffin-embedded tumor samples (or 15 tissue sections at least) and related pathological reports are needed
- Previous treatment with at least one chemotherapy regimen
- At least one measurable lesion
Key exclusion criteria (12 listed)
- Disagreement on blood sample collection
- Patients allergic of chimeric or humanized antibody
- Pregnant or lactating women
- Serious medical illness likely to interfere with participation
- Serious infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab (PD-1 Blocking Antibody)Also: Pembrolizumabpembrolizumab 2mg/kg, ivgtt (intravenously guttae), d1. Every three weeks for one cycle and two cycles are required at least. Efficacy and safety were evaluated every two cycles. | Drug | PD-1 Blocking Antibody |
Primary outcome
Response rate
Time frame: every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug)
21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles.
3 secondary outcomes
Progression-free survival
Time frame: up to end of follow-up-phase (approximately 24 months)
Overall survival
Time frame: up to the date of death (approximately 3 years)
Median survival time
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingzhi Zhang, Pro,Dr principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab (PD-1 Blocking Antibody) in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Mingzhi Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingzhi Zhang, Pro,Dr (13838565629, mingzhi_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.