A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Hodgkin's Lymphoma Clinical Trial

— NB001  

Official title:

A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Nivolumab and Bendamustine Combination (NB) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343652
• Other study ID #: 10/17-n
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 27, 2017
• Est. completion date: March 27, 2020

Study information

• Verified date: May 2020
• Source: St. Petersburg State Pavlov Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 27, 2020
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis: Histologically confirmed Hodgkin's lymphoma

• Relapsed or refractory to at least two prior treatment lines

• Relapsed after nivolumab treatment or refractory to nivolumab treatment

• Age 18-70 years old

• Signed informed consent

• No severe concurrent illness

Exclusion Criteria:

• Uncontrolled bacterial or fungal infection at the time of enrollment

• Requirement for vasopressor support at the time of enrollment

• Karnofsky index <30%

• Pregnancy

• Somatic or psychiatric disorder making the patient unable to sign informed consent

• Active or prior documented autoimmune disease requiring systemic treatment.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• Nivolumab
3 mg/kg IV infusion on day 1,14 up to 3 cycles
• Bendamustine Hydrochloride
90 mg/kg IV infusion on day 1 up to 3 cycles

Locations

Country	Name	City	State
Russian Federation	First Pavlov State Medical University of St. Petersburg	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma	Overall response rate (ORR), defined as proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC criteria and duration of response.	up to 3 months
Secondary	Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03	Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).	up to 12 months
Secondary	Duration of Response (DOR)	Duration of response will be measured from the time of initial response to nivolumab till documented disease progression, death or last evaluation of tumor status.	up to 12 months
Secondary	Time to Progression (TTP)		up to 12 months
Secondary	Progression-Free Survival (PFS)		up to 12 months
Secondary	Overall Survival (OS)		up to 12 months