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

NCT ID: NCT04239170

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab(SHR-1210) Combined With GEMOX

Group Type: EXPERIMENTAL

Camrelizumab(SHR-1210)

Intervention Type: DRUG

Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin

Interventions

Camrelizumab(SHR-1210)

Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin

Intervention Type: DRUG

Other Intervention Names

GEMOX(Gemcitabine, Oxaliplatin)

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed classic Hodgkin's lymphoma ;

2. 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.

3. Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria

4. ECOG performance status of 0 or 1;

5. Life expectancy ≥ 12 weeks.;

6. Adequate laboratory parameters during the screening period as evidenced by the following:

1. Hemoglobin ≥ 90 g/L;

2. Absolute neutrophil count ≥ 1.5 × 109/L ;

3. Platelets ≥ 100 × 109/L;

4. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN),

5. ALT and AST ≤ 2.5×ULN

6. Serum Creatinine ≤1.25×ULN or Creatinine clearance≥60 mL/min;

7. Coagulation function index：INR ≤1.5×ULN，APTT≤1.5×ULN

7. 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.

8. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria

1. Known nodular lymphoma predominant Hodgkin lymphoma

2. History and complication as follows,

1. Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted

2. 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

3. Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose of trial drugs.

4. Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody . Or prior exposure to GEMOX but PD.

5. Participating in other clinical studies or less than 4 weeks before the end of a clinical trial.

6. Known and highly Suspicion of interstitial pneumonia.

7. 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).

8. 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.

9. Prior allo-HSCT.

10. Impact of major surgery or severe trauma had been eliminated for less than 28 days

11. Active pulmonary tuberculosis.

12. Severe acute or chronic infection requiring systemic therapy.

13. Suffering from high blood pressure, and cannot be well controlled by antihypertensive drugs (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)

14. Suffering from heart failure (New York Heart Association standard III or IV). Uncontrolled coronary artery disease and arrhythmia although given appropriate medical treatment. History of myocardial infarction within 6 months.

15. Three months before randomization, there were significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, stool occult blood test is ++ at baseline and above, or vasculitis

3. Laboratory test

1. Known HIV positive or known AIDS.

2. Untreated active hepatitis: Hepatitis B(HBsAg positive and HBV DNA≥500IU/mL), and hepatitis C(HCV RNA positive, abnormal liver function) ,Hepatitis B and hepatitis C infection in common.

4. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.

5. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuqin Song, MD

Role: CONTACT

SongYQ_VIP@163.com

(+8610)88196118

Facility Contacts

Jun Zhu, MD

Role: primary

Zj@bjcancer.org

(+8610)88196596

References

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.

Reference Type: DERIVED

PMID: 38454451 (View on PubMed)

Other Identifiers

SHR-1210-GEMOX-IIT-HL

Identifier Type: -

Identifier Source: org_study_id