- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04796857
Tislelizumab in Combination With Lenalidomide in Refractory and Relapsed Elderly Patients With Non-GCB DLBCL
March 12, 2021 updated by: Huiqiang Huang
Tislelizumab in Combination With Lenalidomide in in Patients With Relapsed or Refractory Elderly Patients With Non-GCB Diffuse Large B Cell Lymphoma: a Prospective Phase Ib/II, Multicentre, Open-label, Single-arm Trial
Aim of this study will evaluate the efficacy and safety of tislelizumab in combination with lenalidomide in in patients with relapsed or refractory Elderly Patients with non-GCB Diffuse Large B Cell Lymphoma
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Elderly patients with relapsed /refractory non-GCB diffuse large B cell lymphoma usually have a bad prognosis.
These patients cannot be treated successfully or tolerated the conventional chemotherapy.
Lenalidomide has a unique therapeutic effect in Non-GCB DLBCL.
Some studies have shown that the combination of lenalidomide and PD-1 antibody shows a synergistic effect in the exploration of DLBCL, and the patients are well tolerated.The investigators will evaluate the efficacy and safety of tislelizumab in combination with lenalidomide in the elderly patients with relapsed refractory non-GCB DLBCL failed from second line chemotherapy.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 1
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: Yan Gao, Doctor
- Phone Number: +86 020 87343350
- Email: gaoyan@sysucc.org.cn
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Department of Medical Oncology, Sun Yat-sen University Cancer Center,
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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
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Volunteers who signed informed consent.
- Age range 60-75 years old; male or female
- DLBCL, or follicular lymphoma grade 3B, or transformed DLBCL, EBV (+) DLBCL, ALK (+) DLBCL, high-grade lymphoma were confirmed by histopathology examination;
- Failed from standard first-line rituximab-contained chemotherapy, and relapsed or refractory after second-line regimens with or without rituximab.
- ECOG performance status 0-1.
- Estimated survival time > 3 months.
- There must be at least one evaluate able or measurable lesion that meets the LYRIC 2016 Malignant Lymphoma criteria [evaluable lesion: 18F-fluorodeoxyglucose/Positron Emission Tomography (18FDG/PET) examination showing increased lymph node or extranodal uptake (higher than liver) and PET and/or computed tomography (Computed Tomography) CT) features are consistent with lymphoma findings; lesions can be measured: nodular lesions > 15mm or extranodal lesions > 10mm (if the only measurable lesion has received radiotherapy in the past, there must be evidence of radiological progress after radiotherapy), and accompanied by increased 18FDG uptake). Except for this, there is no measurable increase in diffuse 18FDG uptake in the liver;
- Adequate organ and bone marrow function, no severe hematopoietic dysfunction, cardiac, pulmonary, liver, kidney, thyroid dysfunction and immune deficiency (no blood transfusion, granulocyte colony stimulating factor or other medical support was received within 14 days prior to the use of the research drug): 1) The absolute value of neutrophils (>1.5×10^9/L); 2) platelet count (> 75×10^9/L); 3) Hemoglobin (> 9 g/dL); 4) Upper Limit Normal (ULN) or creatinine clearance rate (>40 mL/min) of serum creatinine (<1.5 times normal value upper limit) (estimated by Cockcroft-Gault formula); 5) Serum total bilirubin < 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) = 2.5 times ULN; 7) Prior chemotherapy and radiotherapy should have been completed more than 4 weeks. Coagulation function: International Normalized Ratio (INR) = 1.5 times ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) = 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are using anticoagulant therapy at screening time). Within the expected range; 8) Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (+10%);
- There was no evidence that subjects had difficulty breathing at rest, and the measured value of pulse oximetry at rest was more than 92%;
- Participants must pass a pulmonary function test (PFT) to confirm that forced expiratory volume (FEV1)/forced vital capacity (FVC) in the first second is more than 60%, unless it is a large mediastinal mass caused by lymphoma that cannot meet this standard; carbon monoxide diffusion (DLCO), FEV1 and FVC are all above 50% of the predicted value; all PFT results must be obtained within four weeks before the first administration;
- Female patients of childbearing age must have a negative pregnancy test at the time of enrollment and are willing to use reliable contraceptive methods, i.e. barrier methods, oral contraceptives, implant methods, skin contraception, long-acting injection contraceptives, intrauterine devices, or tubal ligation;
- Paraffin tissue specimens or fresh puncture tissue specimens are available.
Exclusion Criteria:
- Hemophagocytic syndrome;
- Primary central nervous system lymphoma or secondary central nervous system involvement;
- Received allogeneic organ transplantation in the past;
- The study began with Allo-HSCT(Allogeneic Hematopoietic Stem Cell Transplantation) within 3 years before treatment;
- Participating in other clinical studies, or less than 4 weeks from the end of the previous clinical study;
- Accepted autologous hemopoietic stem cell transplantation within 3 month before treatment;
- Previously treated with lenanlidomde or immune checkpoint inhibitors within 1 year;
- Thalidomide intolerance;
- Peripheral neurotoxicity > grade 1;
- Under risk of thromboembolism and are unwilling to prevent venous thromboembolism;
- Patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered systematic treatment, such as type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of glucocorticoid replacement therapy); Patients with autoimmune diseases who do not require systematic treatment within two years can be enrolled;
- Begin the study on subjects requiring systemic glucocorticoid therapy or other immunosuppressive therapy for a given condition within 14 days before treatment [allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic absorption); and allowing short-term (< 7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose) Sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by contact allergens), except for tumor reduction due to large tumor burden (prednisone 30mg, bid × 5 days or equivalent dose of other glucocorticoid therapy);
- In the past five years, patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix;
- Begin the study and receive systemic antineoplastic therapy within 28 days before treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or growth factors that control cancer), etc.;
- The study began with major surgery within 28 days before treatment or radiotherapy within 90 days before treatment;
- Start the study and receive Chinese herbal medicine or Chinese 12.patent medicine treatment within 7 days before treatment;
- Begin research on live vaccination (except influenza attenuated vaccine) within 28 days before treatment;
- History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known;
- Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 2500 copies/mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. In addition to active hepatitis B or hepatitis C infections requiring treatment, group trials can be conducted. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 2500 copies/mL or 500 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
- Patients with active pulmonary tuberculosis;
- Start studying any active infections requiring systemic anti-infective treatment within 14 days of treatment.
- Pregnant or lactating women;
- People with known history of alcoholism or drug abuse;
- History of interstitial lung disease or non-infectious pneumonia.
- Subjects who had previously had non-infectious pneumonia caused by drugs or radiation but had no symptoms were allowed to enter the group;
- QTCF interval > 450 msec;
- Past psychiatric history; incapacitated or restricted;
- According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions;
- Other researchers consider it unsuitable for patients to participate in this study.
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: Tislelizumab in Combination With Lenalidomide
On the day of tislelizumab infusion, lenalidomide should be taken 30 minutes after the end of tislelizumab infusion
|
Tislelizumab will be administered every 4 weeks up to 6 cycles during induction phase if patients get CR or PR after induction phase.
Other Names:
Phase I: dose escalation phase. Patients will oral dosage as 10mg, 20mg, per day. Aim to evaluate MTD and DLT, RP2D. Phase II:Patients continuous oral lenalidomide as RP2D up to 6 cycles during induction phase
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR), Investigator-Assessed
Time Frame: up to 24 months
|
Overall response was determined on the basis of investigator assessments according to lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016.
Tumor assessments were performed with CT/MRI with or without PET.
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up to 24 months
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The optimal dosage of lenalidomide
Time Frame: up to 6 months
|
Maximum tolerable dose(MTD)and dose-limiting toxicity(DLT)of lenalidomide will be conducted in Phase Ib clinical studies.
MTD and DLT is defined as protocol-defined lenalidomide related events.
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up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to 36 months
|
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
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Up to 36 months
|
Overall Survival
Time Frame: up to 36 months
|
Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason
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up to 36 months
|
Time To Progression
Time Frame: up to 36 months
|
Time from randomization to PD
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up to 36 months
|
Progression-free Survival
Time Frame: Time Frame: up to 36 months
|
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
|
Time Frame: up to 36 months
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Duration of Response
Time Frame: Time Frame: up to 36 months
|
The time from the first assessment of CR or PR to PD (progressive disease) or death from any cause
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Time Frame: up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Huiqiang Huang, Professor, huanghq@sysucc.org.cn
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 (Anticipated)
March 31, 2021
Primary Completion (Anticipated)
March 31, 2023
Study Completion (Anticipated)
March 31, 2023
Study Registration Dates
First Submitted
March 10, 2021
First Submitted That Met QC Criteria
March 12, 2021
First Posted (Actual)
March 15, 2021
Study Record Updates
Last Update Posted (Actual)
March 15, 2021
Last Update Submitted That Met QC Criteria
March 12, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Large-Cell, Anaplastic
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Antibodies
- Lenalidomide
Other Study ID Numbers
- TALEND
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.
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