PD-1 Inhibitor Combined With Decitabine Followed by ASCT as Second-line Therapy for Relapsed or Refractory Classic Hodgkin's Lymphoma

Relapse Clinical Trial

Official title:

PD-1 Inhibitor Combined With Decitabine Followed by ASCT as Second-line Therapy for Relapsed or Refractory Classic Hodgkin's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05137886
• Other study ID #: IIT2021051-EC-1
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2022
• Est. completion date: January 2025

Study information

• Verified date: December 2021
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Dehui Zou, Dr.
• Phone: 86-022-23909282
• Email: zoudehui[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Young patients with relapsed or refractory classic Hodgkin's lymphoma will be treated with PD-1 inhibitor combined with decitabine as second-line salvage treatment for four cycles. If PR or CR was obtained after salvage treatment, patients will receive GBM conditioning regimen followed by ASCT as consolidation therapy. High-risk R/R cHL patients will be treated with PD-1 inhibitor after ASCT for 1 year. The purpose of current study is to determine the clinical efficacy and safety of PD-1 inhibitor combined with decitabine followed by ASCT as second-line treatment in patients with relapsed or refractory classic Hodgkin's lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory classic Hodgkin lymphoma (HL).

2. 18 to 65 years of age.

3. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.

4. Proper functioning of the major organs: 1) The absolute value of neutrophils (=1×10^9/L); 2) platelet count (=75×10^9/L); 3) Serum creatinine <1.5 times Upper Limit Normal (ULN) ; 4) Serum total bilirubin < 1.5 times ULN; 5) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) =3 times ULN; 6) Serum creatinine (Cr) =2 ULN, or glomerular filtration rate =40ml/min; 7) Thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were all within the normal range (±10%).

5. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.

6. LVEF value measured by echocardiography =50%.

7. Life expectancy > 3 months.

Exclusion Criteria:

1. Patients with central nervous system involvement by lymphoma.

2. 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.

3. Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).

4. Pregnant or breastfeeding women.

5. Major surgery within 4 weeks before enrollment.

6. Impaired cardiac function:Ejection fraction <50% on MUGA scan. QTc interval > 450msecs on baseline ECG. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).

7. Other concurrent severe and/or uncontrolled medical conditions: Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma, Adult
• Lymphoma
• Recurrence
• Refractory Hodgkin Lymphoma
• Relapse

Intervention

Drug:
• PD-1 inhibitor
decitabine 10mg on d1-5, Tislelizumab 200mg on d8,21 days as one cycle.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	PFS	2 years
Secondary	Objective response rate	ORR	2 years
Secondary	Complete response rate	CRR	2 years
Secondary	Duration of response	DOR	2 years
Secondary	Overall survival rate	OS	2 years
Secondary	Severity of the adverse events		2 years