Lowdose Nivolumab in Combination With AVD as Front Line Therapy for Classic Hodgkin's Lymphoma

NCT05772624 | Unknown Phase 2

• 1 other identifier: HE23-0001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to prove the efficacy and safety of low dose nivolumab (40mg as the lowest available presentation) in combination with AVD (adriamycin,vinblastine sulfate and dacarbazine) as frontline treatment for classic Hodgkin's lymphoma.

Conditions

Safety Issues; Efficacy, Self

Keywords

Nivolumab; lowdose nivolumab; NAVD; hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

• To determine general response

  To determine patients achieving either a complete response or a partial response as demonstrated with PET C/T evaluation.

  Six weeks after completion of therapy.

Secondary Outcomes (2)

• Response duration

  up to 2 years

• Adverse effects

  through the study completion and up to 6 months

Study Arms (1)

LowN-AVD

EXPERIMENTAL

classic Hodgkin's lymphoma patients receiving low dose nivolumab in combination with AVD

Drug: low dose nivolumab in combination with AVD

Interventions

low dose nivolumab in combination with AVD DRUG

Nivolumab as an standard dose of 40mg in combination with AVD.

LowN-AVD

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with recent diagnosis of classic Hodgkin's lymphoma demonstrated by incisional or excisional biopsy of adenopathy.
• Treatment naive patients.
• Any stage
• Any functional status.

You may not qualify if:

• Patients with refractory or relapsed disease.
• Patients with non classical variety.
• Patients with chronic or active infections at the moment of recruiting.
• Patients younger than 16 years old.
• Pregnancy

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (5)

• Hwang YY, Khong PL, Kwong YL. Low-dose nivolumab induced remission in refractory classical Hodgkin lymphoma. Ann Hematol. 2017 Jul;96(7):1219-1220. doi: 10.1007/s00277-017-3007-9. Epub 2017 Apr 22. No abstract available.

  PMID: 28434018 RESULT

• Lepik KV, Fedorova LV, Kondakova EV, Zalyalov YR, Babenko EV, Lepik EE, Kotselyabina PV, Beynarovich AV, Popova MO, Volkov NP, Stelmakh LV, Baykov VV, Moiseev IS, Mikhailova NB, Kulagin AD, Afanasyev BV. A Phase 2 Study of Nivolumab Using a Fixed Dose of 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkin Lymphoma. Hemasphere. 2020 Sep 23;4(5):e480. doi: 10.1097/HS9.0000000000000480. eCollection 2020 Oct.

  PMID: 33062947 RESULT

• Brockelmann PJ, Goergen H, Keller U, Meissner J, Ordemann R, Halbsguth TV, Sasse S, Sokler M, Kerkhoff A, Mathas S, Huttmann A, Bormann M, Zimmermann A, Mettler J, Fuchs M, von Tresckow B, Baues C, Rosenwald A, Klapper W, Kobe C, Borchmann P, Engert A. Efficacy of Nivolumab and AVD in Early-Stage Unfavorable Classic Hodgkin Lymphoma: The Randomized Phase 2 German Hodgkin Study Group NIVAHL Trial. JAMA Oncol. 2020 Jun 1;6(6):872-880. doi: 10.1001/jamaoncol.2020.0750.

  PMID: 32352505 RESULT

• Chan TSY, Hwang YY, Khong PL, Leung AYH, Chim CS, Tse EWC, Kwong YL. Low-dose pembrolizumab and nivolumab were efficacious and safe in relapsed and refractory classical Hodgkin lymphoma: Experience in a resource-constrained setting. Hematol Oncol. 2020 Dec;38(5):726-736. doi: 10.1002/hon.2787. Epub 2020 Aug 20.

  PMID: 32786092 RESULT

• Ramchandren R, Domingo-Domenech E, Rueda A, Trneny M, Feldman TA, Lee HJ, Provencio M, Sillaber C, Cohen JB, Savage KJ, Willenbacher W, Ligon AH, Ouyang J, Redd R, Rodig SJ, Shipp MA, Sacchi M, Sumbul A, Armand P, Ansell SM. Nivolumab for Newly Diagnosed Advanced-Stage Classic Hodgkin Lymphoma: Safety and Efficacy in the Phase II CheckMate 205 Study. J Clin Oncol. 2019 Aug 10;37(23):1997-2007. doi: 10.1200/JCO.19.00315. Epub 2019 May 21.

  PMID: 31112476 RESULT

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Perla R Colunga Pedraza, MD

  Hospital Universitario Jose Eleuterio Gonzalez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Gomez Almaguer, MD

CONTACT

+52 8183486136; dgomezalmaguer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 16, 2023
• Study Start: February 13, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)