Health TrialsbyHealthPanel

Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma

ConditionsRelapsed Classic Hodgkin LymphomaRefractory Classic Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNavy General Hospital, Beijing

About this trial

The goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with PD-1 therapy in treating patients with relapsed/refractory classic Hodgkin lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed Hodgkin Lymphoma according World Health Organization (WHO) classification.

Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).

Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.

Patient is willing and able to adhere to the study visit schedule and other protocol requirements.

Disqualifiers

Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.

Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.

Pregnant or lactating women.

Trial design

Design model

Single group

Treatments tested in this trial

  • Azacitidine Plus PD-1 therapy

    Drug

    Patients were treated by Azacytidine(75 mg/m2 subcutaneous injection qd on days 1-7) plus PD-1 therapy(200mg iv qd d8)

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Azacitidine Plus PD-1 therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

ORR was defined as the proportion of patients who achieved CR or PR as their best response

Time frame
1 year

Secondary outcomes

1

Overall Survival (OS)

OS was defined as time from diagnosis to death from any cause or the last follow-up

Time frame
through study completion, an average of 2 year
2

Progression Free Survival (PFS)

PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Navy General Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov
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