Anti-PD-1 and Chemotherapy for R/R Hodgkin Lymphoma

Hodgkin Lymphoma Clinical Trial

Official title:

Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664323
• Other study ID #: Anti-PD-1 Hodgkin
• Status: Completed
• Start date: January 31, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.

In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2018
• Est. primary completion date: January 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Initial diagnosis of classical HL

• Optional histopathology confirmation of relapse/refractory HL, (2) age = 18 years

• Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 2

• Patients must be have received: at least 2 prior regimens and have received or be ineligible for autologous stem cell transplant and must have received prior BV, and at least 2 cycles of single agent anti-PD-1 as last treatment before entering the study,

• Patients must have inadequate response to anti-PD-1 monotherapy (progressive disease or partial response according to Lugano criteria) with at least one hypermetabolic lesion over the liver and mediastinum background at time of inclusion in the study

• Previous allogeneic stem cell transplant was allowed. Patients treated with radiotherapy alone after anti-PD1 or combined with anti-PD1 treatment were not included in the study.

Exclusion Criteria:

• radiotherapy in the treatment after anti-PD1

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Biological:
• Evaluate the improvement in response from the end of anti-PD-1 monotherapy
Evaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2).

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate after re-exposure to chemotherapy	Patient evaluation was timed by treating physicians according to the policy of each center, and all patients were evaluated after a median of 10 weeks (min 7 weeks, max 12 weeks) with PET/CT using Lugano criteria	10 weeks
Secondary	Best response obtained (Group 1)	the best response obtained with CT after anti-PD-1	10 weeks
Secondary	Best response obtained (Group 2)	the best response obtained with CT after the combination anti-PD-1 and CT	10 weeks
Secondary	The toxicities experienced during CT or anti-PD-1 plus CT combination	The toxicities were graded retrospectively according to the National Cancer Institute Common Toxicity Criteria for AEs (version 4.0).	10 weeks
Secondary	Outcomes including PFS	PFS was defined as the time from first relapse, or progression, to the next event (defined as either second relapse/progression, change of therapy, or death from any cause)	up to 12 months
Secondary	Outcomes including overall survival (OS).	OS was defined as the time from first relapse, or progression, to death from any cause.	up to 24 months