Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedNCT05821192
Chemotherapy Plus PD-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T-cell Lymphoma.
A study testing Rituximab, Gemcitabine and Dexamethasone in people with Peripheral T-Cell Lymphoma, Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma, run by Ou Bai, MD/PHD at 1 site in China.
Trial summary
A multi-center, prospective clinical study to evaluate the efficacy and safety of R-GDP plus PD-1 monoclonal antibody in the treatment of refractory or relapsed peripheral T cell lymphoma not otherwise specified and Angioimmunoblastic T-cell lymphoma, which has previously shown promising efficacy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- Rituximab, Gemcitabine and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic T-cell lymphoma confirmed by histopathology;
- Age 18 to 70 years for all sexs;
- Progressive disease or no response in patients who have received first-line chemotherapy (at least 2 cycles), and patients who refuse or can't suffer from intravenous chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- Life expectancy ≥ 3 months;
- There are measurable lesions (lymph nodes enlargement, nodal masses, enlargement of lymphoid organs and extranodal lesion that are measurable in two diameters (longest diameter and shortest diameter). A measurable node must have an longest diameter greater than 1.5 cm. A measurable extranodal lesion should have an longest diameter greater than 1.0 cm.);
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- Function of organs:
- Hepatic function: Total bilirubin ≤ 1.5 times upper limit of normal (ULN), direct bilirubin ≤ 1.5 times ULN; aspartate aminotransferase (AST) or Alanine aminotransferase （ALT） ≤ 2.5 times ULN (5 times ULN if liver involvement with lymphoma);
- Bone marrow function (without growth factor in 7 days before the first drugs): WBC ≥ 2.0×109/l; ANC ≥ 1.0×109/l; PLT ≥ 50×109/l; Hb ≥ 8g/dl;
- Renal function: Creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 30ml/min or creatinine clearance rate ≤ 2.5 times ULN;
- Pulmonary function: blood oxygen saturation ≥ 95% in resting state without oxygen inhalation;
- Coagulation function: international normalised ratio (INR) ≤ 1.5 times ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN (Patients whose prolonged PT or increased INR resulted in clotting factor inhibitors, should be selected at the investigator's discretion);
- Heart function: LVEF ≥ 50%;
Who cannot join
- Unrelieved toxic reaction CTCAE grade > 1 before the first drugs in this research (except adverse effects that won't affect this study, estimated by the investigator, such as alopecia);
- There is an active infection, including but not limited to known active tuberculosis, known latent tuberculosis, herpes zoster and pneumonia;
- Patient is known to be positive for Human immunodeficiency virus (HIV) infection; Or serological status reflect active hepatitis B virus(HBV) infection or active hepatitis C virus (HCV) infection:
- Patients with HBsAg(+), HBcAb (+) or HBsAg (+) should detect HBV-DNA. Patients who has HBV-DNA ≤ 1000IU/ml and agree to have anti-HBV therapy can be selected;
- Patients with HCVAb (+) and HCV RNA < 15 IU/mL can be selected;
- Heart failure with New York Heart Association （NYHA） grade III or IV, unstable angina pectoris, severe ventricular arrhythmias with poor control, acute myocardial ischemia showed by electrocardiogram or had myocardial infarction in 6 months before screening. Or patients can't suffer from chemotherapy due to other heart function disorders, estimated by investigator;
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- Intractable nausea or vomiting that can't be controlled by supportive care, chronic gastrointestinal diseases or dysphagia of capsules, or had intestinal resection which may affect the drug absorption;
- The investigator determined or other evidence showed patients have severe or poorly controlled systemic diseases, including poorly controlled hypertension and active bleeding body constitution. Patients with thrombotic diseases such as pulmonary embolism and deep venous thrombosis are also not suitable to participate in this study;
- Patients have interstitial pneumonia or once had chemotherapy-induced interstitial pneumonia during chemotherapy, who have treatment risk in the estimation of investigator;
- Pregnant or lactating women;
- The investigator determine the patients having other infectors which may affect compliance;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Ou BAI, doctor, 13039046656, oubai16@163.com
About this study
Official title: A Prospective Clinical Study of Chemotherapy Plus Programmed Death-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T Cell Lymphoma Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma.
A multi-center, prospective clinical study to evaluate the efficacy and safety of R-GDP plus PD-1 monoclonal antibody in the treatment of refractory or relapsed peripheral T cell lymphoma not otherwise specified and Angioimmunoblastic T-cell lymphoma, which has previously shown promising efficacy.
Read the detailed description
Objective to evaluate the efficacy and safety of R-GDP (Rituximab, Gemcitabine, Dexamethasone, Cisplatin) plus PD-1 monoclonal antibody in patients with refractory or relapsed peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic T-cell lymphoma.
- Being tested
- Rituximab, Gemcitabine, Dexamethasone, Cisplatin, PD-1 monoclonal antibody
- Medical subject headings
- Lymphoma, T-Cell, Immunoblastic Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
375mg/m2 by IV infusion once every 3 weeks
GemcitabineDrug
1 g/m2 on Days 1 by IV infusion once every 3 weeks
DexamethasoneDrug
40 mg on Days 1 to 4 of each 3-week cycle by IV infusion
CisplatinDrug
75 mg/m2 on Days 1 by IV infusion once every 3 weeks
PD-1 monoclonal antibodyDrug
200mg on Days 2 by IV infusion once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| R-GDP plus PD-1 monoclonal antibody | Experimental | Rituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody Receives: Drug: Rituximab; Drug: Gemcitabine; Drug: Dexamethasone; Drug: Cisplatin; Drug: PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Percentage of Complete remission (CR), and Partial remission (PR).
Measured: 16 months
Secondary outcomes (4)
Progression-free survival (PFS)
Progression-free survival#PFS# is defined as the time from the date of enrollment to the date of first documentation of progressive disease (PD) or death from any cause.
Measured: 24 months
Overall survival (OS)
Overall survival#OS# is defined as the time from the date of enrollment to the date of death from any cause.
Measured: 24 months
Incidence of adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Measured: 24 months
Serious Adverse Event (SAE)
A serious adverse event will be considered any undesirable sign, symptom, or medical condition with one or more of the following outcomes:
- is fatal, is life-threatening
- requires or prolongs inpatient hospitalization
- results in persistent or significant disability/incapacity
- constitutes a congenital anomaly or birth defect
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start23 Mar 2023
- Primary completion18 Apr 2023 (estimated)
- Study completion31 Dec 2024 (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 Lymphoma, Not Otherwise SpecifiedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ou Bai, MD/PHD
- Sponsor type
- University, hospital or other
- Collaborators
- Second Hospital of Jilin University, China-Japan Union Hospital, Jilin University
- Responsible party
- Sponsor-investigator, Ou Bai, MD/PHD, The First Hospital of Jilin University
- Investigators
- Ou Bai, doctor, Study chair, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821192
- Sponsor's protocol ID
- rrPTCL-R-PD1-001
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 20 Apr 2023
- Results posted
- 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Chemotherapy Plus Programmed Death-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T Cell Lymphoma Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT05821192
- Acronym / sponsor ID
- rrPTCL-R-PD1-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ou Bai, MD/PHDUniversity, hospital or other
- Collaborators
- Second Hospital of Jilin University, China-Japan Union Hospital, Jilin University
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 18 Apr 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Apr 2023 (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.
A multi-center, prospective clinical study to evaluate the efficacy and safety of R-GDP plus PD-1 monoclonal antibody in the treatment of refractory or relapsed peripheral T cell lymphoma not otherwise specified and Angioimmunoblastic T-cell lymphoma, which has previously shown promising efficacy.
Detailed description
Objective to evaluate the efficacy and safety of R-GDP (Rituximab, Gemcitabine, Dexamethasone, Cisplatin) plus PD-1 monoclonal antibody in patients with refractory or relapsed peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic 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 |
|---|---|---|
| R-GDP plus PD-1 monoclonal antibody | Experimental | Drug: Rituximab, Drug: Gemcitabine, Drug: Dexamethasone, Drug: Cisplatin, Drug: PD-1 monoclonal antibodyRituximab, Gemcitabine, Cisplatin, Dexamethasone, PD-1 monoclonal antibody |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic T-cell lymphoma confirmed by histopathology;
- Age 18 to 70 years for all sexs;
- Progressive disease or no response in patients who have received first-line chemotherapy (at least 2 cycles), and patients who refuse or can't suffer from intravenous chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- Life expectancy ≥ 3 months;
Key exclusion criteria (11 listed)
- Unrelieved toxic reaction CTCAE grade > 1 before the first drugs in this research (except adverse effects that won't affect this study, estimated by the investigator, such as alopecia);
- There is an active infection, including but not limited to known active tuberculosis, known latent tuberculosis, herpes zoster and pneumonia;
- Patient is known to be positive for Human immunodeficiency virus (HIV) infection; Or serological status reflect active hepatitis B virus(HBV) infection or active hepatitis C virus (HCV) infection:
- Heart failure with New York Heart Association （NYHA） grade III or IV, unstable angina pectoris, severe ventricular arrhythmias with poor control, acute myocardial ischemia showed by electrocardiogram or had myocardial infarction in 6 months before screening. Or patients can't suffer from chemotherapy due to other heart function disorders, estimated by investigator;
- Intractable nausea or vomiting that can't be controlled by supportive care, chronic gastrointestinal diseases or dysphagia of capsules, or had intestinal resection which may affect the drug absorption;
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 |
|---|---|---|
| Rituximab375mg/m2 by IV infusion once every 3 weeks | Drug | R-GDP plus PD-1 monoclonal antibody |
| Gemcitabine1 g/m2 on Days 1 by IV infusion once every 3 weeks | Drug | R-GDP plus PD-1 monoclonal antibody |
| Dexamethasone40 mg on Days 1 to 4 of each 3-week cycle by IV infusion | Drug | R-GDP plus PD-1 monoclonal antibody |
| Cisplatin75 mg/m2 on Days 1 by IV infusion once every 3 weeks | Drug | R-GDP plus PD-1 monoclonal antibody |
| PD-1 monoclonal antibody200mg on Days 2 by IV infusion once every 3 weeks | Drug | R-GDP plus PD-1 monoclonal antibody |
Primary outcome
Objective response rate (ORR)
Time frame: 16 months
Percentage of Complete remission (CR), and Partial remission (PR).
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Incidence of adverse events (AEs)
Time frame: 24 months
Serious Adverse Event (SAE)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- 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.
Ou Bai, doctor study chair
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab, Gemcitabine and Dexamethasone in people with Peripheral T-Cell Lymphoma, Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma, run by Ou Bai, MD/PHD 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 13 inclusion and 11 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 20 Apr 2023. 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.
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 Ou Bai, doctor (13039046656, oubai16@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 16 months). 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 20 Apr 2023.