Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma | NCT06190067

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

NCT06190067

Sponsor

Navy General Hospital, Beijing

Status

Recruiting

Last Update Posted

Jan 30, 2024Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Relapsed Classic Hodgkin Lymphoma
Refractory Classic Hodgkin Lymphoma

Interventions

Azacitidine Plus PD-1 therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Dec 19, 2023

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Jan 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2024

Last Update Posted Date

Jan 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with PD-1 therapy in classic relapsed/refractory Hodgkin lymphoma.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azacitidine Plus PD-1 therapy	Experimental	Patients were treated by Azacitidine plus PD-1 therapy	Drug: Azacitidine Plus PD-1 therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)	Azacitidine Plus PD-1 therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR was defined as the proportion of patients who achieved CR or PR as their best response	1 year

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as time from diagnosis to death from any cause or the last follow-up	through study completion, an average of 2 year
Progression Free Survival (PFS)	PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below).
Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10^9/L (≥ 1 x 10^9/L if bone marrow (BM) involvement by lymphoma); Platelet ≥ 75 x 10^9/L (≥ 50 x 10^9/L if BM involvement by lymphoma); Hemoglobin ≥ 8 g/dL.
Anticipated life expectancy at least 3 months.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides