Clinical trial NCT05137886: PD-1 Inhibitor Combined With Decitabine Followed by ASCT as Second-line Therapy for Relapsed or Refractory Classic Hodgkin's Lymphoma
Official title: PD-1 Inhibitor Combined With Decitabine Followed by ASCT as Second-line Therapy for Relapsed or Refractory Classic Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hodgkin Lymphoma, Adult
Relapse
Refractory Hodgkin Lymphoma
Keywords: Hodgkin lymphoma
relapse
refractory
autologous stem cell transplantation
PD-1 inhibitor
decitabine
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate
timeFrame: 2 years
measure: Complete response rate
timeFrame: 2 years
measure: Duration of response
timeFrame: 2 years
measure: Overall survival rate
timeFrame: 2 years
measure: Severity of the adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Dehui Zou, Dr.
role: PRINCIPAL_INVESTIGATOR
References: