Peripheral T-cell LymphomaPhase 4NCT04040491
PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
A Phase 4 study testing PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine in people with Peripheral T-cell Lymphoma, run by Mingzhi Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2021
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mingzhi Zhang, Pro,Dr, +8613838565629, Mingzhi_zhang@126.com
Mingzhi Zhang, Zhang, +8613838565629, Mingzhi_zhang@126.com
About this study
Official title: Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
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.
Read the 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.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine
- Keywords
- PD-1, chidamide, lenalidomide, gemcitabine, Peripheral T-cell Lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 blocking antibody, chidamide, lenalidomide and gemcitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed PTCL | Experimental | 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. Receives: Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine |
| Relapse/refractory PTCL | Other | 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. Receives: Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization until the date tumor volume has reduced, assessed up to 36 months
Progression-free Survival
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Measured: 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 from randomization to death for any reason
Measured: From date of randomization until date of death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies 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 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Model description
- 50 patients for newly diagnosed group and 50 patients for relapse/refractory group.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingzhi Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingzhi Zhang, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040491
- Sponsor's protocol ID
- hnslblzlzx20190702
- Status last verified
- May 2020
- First submitted
- 2 Jul 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04040491
- Acronym / sponsor ID
- hnslblzlzx20190702
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- PD-1, chidamide, lenalidomide, gemcitabine, Peripheral T-cell Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 31 Jul 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50 patients for newly diagnosed group and 50 patients for relapse/refractory group.
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed PTCL | Experimental | Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabinePD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle. |
| Relapse/refractory PTCL | Other | Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabinePD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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）;
Key exclusion criteria (17 listed)
- 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）；
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 |
|---|---|---|
| PD-1 blocking antibody, chidamide, lenalidomide and gemcitabinePD-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. | Drug | Newly diagnosed PTCL, Relapse/refractory PTCL |
Primary outcome
Overall Response Rate
Time frame: 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine in people with Peripheral T-cell Lymphoma, 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 10 inclusion and 17 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 12 May 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 D Zhang (+8613838565629 ext. +8613838565629, Mingzhi_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: From date of randomization until the date tumor volume has reduced, assessed up to 36 months). The study lists 3 primary outcomes in all. 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 12 May 2020.