INPHOG-HL-26-05

Phase II Study of Bendamustine and Fixed-Dose Nivolumomab in Children with Relapsed or Refractory Hodgkin Lymphoma

PI : Dr. Shyam Srinivasan

Institution : Tata Memorial Hospital, Mumbai

About the Study

This is a prospective phase 2, open-label, multicenter, risk-stratified, study in children and young adults (aged 5-25 years) with rrHL to study the efficacy of fixed dose nivo-lumab and bendamustine in achieving remission. We also aim to study the utility of fixed low dose nivolumab as maintenance therapy in patients with rrHL.

Aim of the Study

To evaluate the efficacy and safety of the combination of Bendamustine and fixed-dose Nivolumab in achieving remission in children and young adults (aged 5–25 years) with relapsed or refractory Hodgkin lymphoma, and to assess the utility of low-dose nivolumab as maintenance therapy in sustaining remission.

Eligibility Criteria

Inclusion Criteria

Participants aged ≥5 and ≤25 years.
All diagnosed cases of first or subsequent relapse HLproven by histopathologyfrom a biopsy.
Primary progressive HL (less than 3 months of primary treatment) proven by histopathology from a biopsy.
Relapse/refractory HL post autologous transplant.
Relapsed/refractory HL with prior exposure to brentuximab vedotin as part of frontline therapy.
Relapsed/refractory Hodgkin lymphoma with prior exposure to nivolumab during frontline therapy is eligible unless documented primary non-response to nivolumab.
Written informed consent according to institutional guidelines.

Exclusion Criteria

Participants <5 years or >25 years of age.
Subjects with nodular lymphocyte-predominant HL.
HL previously documented to be nonresponsive to nivolumab.
Prior radiation therapy within 3 weeks, or chest radiation<24 weeks prior to first cycle of therapy.
Seropositive for hepatitis B, hepatitis C, and HIV.
History of or active autoimmune disease.
Subjects with active interstitial pneumonitis.
History of allergy to study drug components.
Patients with renal, liver or cardiac compromise as determined by the clinician.