Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT04239170 | Unknown Phase 2

• 1 other identifier: SHR-1210-GEMOX-IIT-HL
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single arm, Phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with Gemox in patients with relapsed and refractory hodgkin lymphoma who will receive ASCT.Efficacy will be assessed according to 2014 Lugano criteria.

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Response

  Based on Lugano 2014 criteria

  From first patient first visit to 3 month after last patient first visit

Secondary Outcomes (1)

• Objective Response Rate

  From first patient first visit to 3 month after last patient first visit

Study Arms (1)

Camrelizumab(SHR-1210) Combined With GEMOX

EXPERIMENTAL

Drug: Camrelizumab(SHR-1210)

Interventions

Camrelizumab(SHR-1210) DRUG

Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin

Also known as: GEMOX(Gemcitabine, Oxaliplatin)

Camrelizumab(SHR-1210) Combined With GEMOX

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed classic Hodgkin's lymphoma ;
• Relapsed or refractory cHL and meet any of the following criterions:a)did not achieve remission or progression and will receive autologous hematopoietic stem cell transplantation.b)receive no more than 3 lines of systemic chemotherapy.
• Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
• ECOG performance status of 0 or 1;
• Life expectancy ≥ 12 weeks.;
• Adequate laboratory parameters during the screening period as evidenced by the following:
• Hemoglobin ≥ 90 g/L;
• Absolute neutrophil count ≥ 1.5 × 109/L ;
• Platelets ≥ 100 × 109/L;
• Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN),
• ALT and AST ≤ 2.5×ULN
• Serum Creatinine ≤1.25×ULN or Creatinine clearance≥60 mL/min;
• Coagulation function index：INR ≤1.5×ULN，APTT≤1.5×ULN
• Women of childbearing potential（WOCBP）with pregnancy test negative within 7 days before entering the group and consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment; Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment.
• Able to understand and sign an informed consent form (ICF).

You may not qualify if:

• Known nodular lymphoma predominant Hodgkin lymphoma
• History and complication as follows,
• Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
• Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids \> 10 mg/day topical prednisone or equivalent are prohibited within 2 weeks before entering the group
• Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose of trial drugs.
• Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody . Or prior exposure to GEMOX but PD.
• Participating in other clinical studies or less than 4 weeks before the end of a clinical trial.
• Known and highly Suspicion of interstitial pneumonia.
• Other active malignancies that required treating. (subjects with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who had no disease recurrence within 5 years after the start of treatment were excluded).
• Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1.
• Prior allo-HSCT.
• Impact of major surgery or severe trauma had been eliminated for less than 28 days
• Active pulmonary tuberculosis.
• Severe acute or chronic infection requiring systemic therapy.
• Suffering from high blood pressure, and cannot be well controlled by antihypertensive drugs (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

• Liu Y, Ping L, Song Y, Tang Y, Zheng W, Liu W, Ying Z, Zhang C, Wu M, Feng F, Lin N, Tu M, Zhu J, Xie Y. Camrelizumab plus gemcitabine and oxaliplatin for relapsed or refractory classical Hodgkin lymphoma: a phase II trial. BMC Med. 2024 Mar 7;22(1):107. doi: 10.1186/s12916-024-03329-8.

  PMID: 38454451 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

camrelizumab; Oxaliplatin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Yuqin Song, MD

CONTACT

(+8610)88196118; SongYQ_VIP@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 23, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)