Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

NCT ID: NCT06984146

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2029-01-31

Brief Summary

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The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma

Detailed Description

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Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.

Conditions

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Hodgkin Lymphoma, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nivo40-AVD

Nivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

40 mg day 1 and 15

Doxorubicin

Intervention Type DRUG

25 mg/m2 day 1 and 15

Vinblastine

Intervention Type DRUG

6 mg/m2 (not exceeding 10 mg) day 1 and 15

Dacarbazine

Intervention Type DRUG

375 mg/m2 day 1 and 15

Interventions

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Nivolumab

40 mg day 1 and 15

Intervention Type DRUG

Doxorubicin

25 mg/m2 day 1 and 15

Intervention Type DRUG

Vinblastine

6 mg/m2 (not exceeding 10 mg) day 1 and 15

Intervention Type DRUG

Dacarbazine

375 mg/m2 day 1 and 15

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma
2. No past history of autoimmune disease
3. Age \> 18 years
4. Ejection fraction \> 50%
5. ECOG 0-4

Exclusion Criteria

1. Organ failure (e.g. creatinine \> 2x ULN; ALT or AST \> 5x ULN; bilirubin \> 2x ULN; hemodynamic instability; respiratory failure \> Grade 1)
2. Uncontrolled infection
3. Pregnancy
4. Inability to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Radiological Centre of the Ministry of Health of Russia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrey Kaprin

Role: STUDY_CHAIR

FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation

Locations

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P. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Mobil Akhmedov, MD, PhD

Role: CONTACT

79261802399

Facility Contacts

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Mobil Akhmedov, MD, PhD

Role: primary

79261802399

Other Identifiers

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Nivo40-AVD

Identifier Type: -

Identifier Source: org_study_id

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