Tislelizumab in Combination With Lenalidomide in Refractory and Relapsed Elderly Patients With Non-GCB DLBCL

NCT04796857 | Unknown Phase 1

• 1 other identifier: TALEND
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-GCB/ABC Diffuse Large B-Cell Lymphoma; High-grade B-cell Lymphoma; Follicular Lymphoma Grade IIIb; Transformed Lymphoma; EBV-Positive DLBCL, Nos; ALK-Positive Anaplastic Large Cell Lymphoma

Keywords

DLBCL; Non-GCB/ABC; Relapsed; Refractory; Elderly Patients

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR), Investigator-Assessed

  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.

  up to 24 months

• The optimal dosage of lenalidomide

  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.

  up to 6 months

Secondary Outcomes (5)

• Progression-free Survival

  Time Frame: up to 36 months

• Overall Survival

  up to 36 months

• Duration of Response

  Time Frame: up to 36 months

• Time To Progression

  up to 36 months

• Percentage of Participants With Adverse Events (AEs)

  Up to 36 months

Study Arms (1)

Tislelizumab in Combination With Lenalidomide

EXPERIMENTAL

On the day of tislelizumab infusion, lenalidomide should be taken 30 minutes after the end of tislelizumab infusion

Drug: PD-1 Antibody; Drug: Lenalidomide

Interventions

PD-1 Antibody DRUG

Tislelizumab will be administered every 4 weeks up to 6 cycles during induction phase if patients get CR or PR after induction phase.

Also known as: Tislelizumab

Tislelizumab in Combination With Lenalidomide

Lenalidomide DRUG

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

Also known as: revlimid

Tislelizumab in Combination With Lenalidomide

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Huiqiang Huang: lead

Study Sites (1)

Department of Medical Oncology, Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic; Recurrence

Interventions

spartalizumab; tislelizumab; Lenalidomide

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Huiqiang Huang, Professor

  huanghq@sysucc.org.cn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Gao, Doctor

CONTACT

+86 020 87343350; gaoyan@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: March 31, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)