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

NCT05137886 | Unknown Phase 2

• 1 other identifier: IIT2021051-EC-1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma, Adult; Relapse; Refractory Hodgkin Lymphoma

Keywords

Hodgkin lymphoma; relapse; refractory; autologous stem cell transplantation; PD-1 inhibitor; decitabine

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  PFS

  2 years

Secondary Outcomes (5)

• Objective response rate

  2 years

• Complete response rate

  2 years

• Duration of response

  2 years

• Overall survival rate

  2 years

• Severity of the adverse events

  2 years

Study Arms (1)

PD-1 inhibitor combined with decitabine followed by ASCT

EXPERIMENTAL

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.

Drug: PD-1 inhibitor

Interventions

PD-1 inhibitor DRUG

decitabine 10mg on d1-5, Tislelizumab 200mg on d8，21 days as one cycle.

Also known as: decitabine, autologous stem cell transplantation

PD-1 inhibitor combined with decitabine followed by ASCT

Eligibility Criteria

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

You may qualify if:

• Subjects must have histological confirmation of relapsed or refractory classic Hodgkin lymphoma (HL).
• to 65 years of age.
• Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
• 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%).
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
• LVEF value measured by echocardiography ≥50%.
• Life expectancy \> 3 months.

You may not qualify if:

• Patients with central nervous system involvement by lymphoma.
• 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.
• Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).
• Pregnant or breastfeeding women.
• Major surgery within 4 weeks before enrollment.
• 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).
• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Recurrence

Interventions

Immune Checkpoint Inhibitors; Decitabine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Dehui Zou, Dr.

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dehui Zou, Dr.

CONTACT

86-022-23909282; zoudehui@ihcams.ac.cn

Huimin Liu, Dr

CONTACT

86-022-23909282; liuhuimin@ihcams.ac.cn

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: Assistant Director of lymphoma Diagnosis and Treatment Center

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 30, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

CN (1)