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Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL

ConditionHodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSt. Petersburg State Pavlov Medical University

About this trial

Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific therapy;

Patients with evidence of lesion extent assessed by whole-body PET/CT;

Patients aged 18-60 years;

ECOG 0-2;

Disqualifiers

Severe organ failure: creatinine > 2 norms; alanine aminotransferase, aspartate aminotransferase > 5 norms; bilirubin> 1.5 norms;

Respiratory failure > grade 1 at the time of enrollment

Requirement for vasopressor support at the time of enrollment

Uncontrolled bacterial or fungal infection at the time of enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nivo-AVD

    Drug

    1. Monotherapy phase - Nivolumab - 40 mg every 14 days x 2 cycles 2. Combination therapy phase - Nivo-AVD x 6 cycles Nivolumab - 40 mg every 14 days; Doxorubicin 25 mg/m2 in D1 and 15; Vinblastine 6 mg/m2 (no more than 10 mg) in D 1 and 15; Dacarbazine 375 mg/m2 in D 1 and 15;

  • BEACOPP-like

    Drug

    * BEACOPP-like regimens x 2 cycles + BEACOPP-like regimens x 4 (for patients with PR, SD by PET/CT after 2 cycles) * BEACOPP-like regimens x 2 + A(B)VD x 4 cycles (for patients with CR by PET/CT after 2 cycles)

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: Nivo-AVDExperimental treatment 1 intervention
Group B: BEACOPP-like regimes - Standard cohortActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events

To compare the safety of therapy use in the Nivo-AVD and Standard cohorts: analysis of the incidence, severity and spectrum of adverse events (according to CTCAE v5.0 criteria)

Time frame
Up to 24 months from thetreatment start

Secondary outcomes

1

Progression-free survival

To compare progression-free survival in the Nivo-AVD and Standard cohorts

Time frame
12, 24 and 36 months after completion of therapy
2

Response rates

To compare the rates of objective response, complete and partial responses after 2 and 6 courses of therapy in the Nivo-AVD and Standard cohorts by whole-body PET-CT (according to Lugano criteria for chemotherapy and LYRIC criteria for immunochemotherapy)

Time frame
after 2 cycles of nivo and 2 cycles of Nivo-AVD (3 months from therapy initiation) and at the end of treatment (7 months from therapy initiation) and, in Standard cohorts, after 2 cycles and EOT of BEACOPPesc (2 and 6 months)
3

Overall survival

\- To compare overall survival at 12, 24, and 36 months after completion of therapy in the Nivo-AVD and Standard cohorts.

Time frame
12, 24, and 36 months after completion of therapy

Other outcomes

Sponsors and contacts

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

St. Petersburg State Pavlov Medical University

Lead sponsor

Source ClinicalTrials.gov
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