PD-1 Inhibitor Combined With Decitabine Followed by ASCT as Second-line Therapy for Relapsed or Refractory Classic Hodgkin's Lymphoma
NCT ID: NCT05137886
Last Updated: 2021-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
47 participants
INTERVENTIONAL
2022-01-31
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PD-1 inhibitor combined with decitabine followed by ASCT
Patients will receive salvage treatment of PD-1 inhibitor Tislelizumab combined with decitabine for four cycles, If PR or CR was obtained after salvage treatment, patients will receive GBM (gemcitabine, bulsufan and melphalan) conditioning regimen followed by ASCT. High-risk patients will receive PD-1 inhibitor for 1 year after ASCT as maintenance therapy.
PD-1 inhibitor
decitabine 10mg on d1-5, Tislelizumab 200mg on d8，21 days as one cycle.
Interventions
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PD-1 inhibitor
decitabine 10mg on d1-5, Tislelizumab 200mg on d8，21 days as one cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Zou Dehui
Assistant Director of lymphoma Diagnosis and Treatment Center
Principal Investigators
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Dehui Zou, Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Dehui Zou, Dr.
Role: primary
Huimin Liu, Dr.
Role: backup
Other Identifiers
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IIT2021051-EC-1
Identifier Type: -
Identifier Source: org_study_id