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PD-1 monoclonal antibody (tirelizumab) alternative radiotherapy for children with classic Hodgkin's lymphoma: a prospective, one-arm, open-label real-world study

PD-1 monoclonal antibody (tirelizumab) alternative radiotherapy for children with classic Hodgkin's lymphoma: a prospective, one-arm, open-label real-world study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033599
Enrollment
Unknown
Registered
2020-06-06
Start date
2020-06-05
Completion date
Unknown
Last updated
2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children's classic Hodgkin's lymphoma

Interventions

experimental group:Intravenous Tislelizumab

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients younger than 18 years old; 2. Patients confirmed as classical Hodgkin's lymphoma by pathological diagnosis of tumor tissue; 3. The selected patients have reached CR after pre-treatment and meet one of the following conditions: (all stages refer to Ann Arbor stage, and all groups follow 2017-cncl-hl scheme) (1) Initial treatment of low-risk patients: stage I - II a, no giant tumor and early evaluation pet did not reach CMR (2) The patients with stage IB, IIIA and without large tumor focus (3) High risk patients in the first treatment: stage IIB, IIIB and IV patients without large tumor focus (including more than 4 lymph nodes involved). (4) Relapsed patients who had previously received radiotherapy at the time of initial treatment. 4. Patients with enough organ function and ECoG score of 0-2; 5. Patients with traceable medical records during treatment; 6. The subjects volunteered to join the study, signed informed consent form, good compliance, and cooperated with follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with hemophagocytic syndrome; 2. Patients with interstitial lung disease, acute and chronic infection requiring systemic treatment, autoimmune disease requiring systemic treatment and long-term oral hormone; 3. Patients who have previously used anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies; 4. Patients who have had allogeneic hematopoietic stem cell transplantation before; 5. Patients who stopped chemotherapy for less than 3 weeks before medication; 6. Patients who had hematopoietic stem cell transplantation 90 days before the treatment; 7. According to the judgment of the investigator, the patient may have other factors that may lead to the forced termination of the study, such as other serious diseases or serious laboratory examination abnormalities or other factors that may affect the safety of the subject, or the family or society of the test data and sample collection.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics;Security features;Clinical efficacy;

Countries

China

Contacts

Public ContactYonghong Zhang

Beijing Boren Hospital

zhangyongh@borenhospital.com+86 13701251969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026