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

Safety Issues Clinical Trial

Official title:

Safety and Efficacy Evaluation of Low-dose Nivolumab in Combination With AVD as Frontline Therapy for Classic Hodgkin's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772624
• Other study ID #: HE23-0001
• Status: Recruiting
• Phase: Phase 2
• Start date: February 13, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: David Gomez Almaguer, MD
• Phone: +52 8183486136
• Email: dgomezalmaguer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The main objective of this project is to prove the efficacy and safety of Nivolumab used as an standard dose of 40mg ( as the lowest available presentation) in combination with AVD as frontline therapy for Hodgkin's lymphoma.

Patients classification.

We will categorize patients in three groups as follows:

1. Early stages by Ann-arbor classification (I,II) with no risk factors (as stablished by NCCN's guidelines criteria).

2. Early stages by Ann.arbor classification (I,II) with risk factors ( as stablished by NCCN's guidelines criteria).

3. Advanced stages by Ann-arbor classification (III,IV).

Methodology:

• Patients will receive two initial cycles of NAVD therapy ( each with two applications in day 1 and 15) and then will be evaluated with an interim PET/CT after completing cycle 2.

• According to the PET C/T results, patients will be categorized as fast responsers (patients who achieve Deauville 1-3 classification) and low responsers ( patients who achieve Deauville 4-5).

• Fast responsers will receive following cycles without nivolumab (2 extra cycles for patients categorized as early stage with no risk factors, 4 extra cycles for patients categorized as early stages with risk factors and for advanced stages).

• Patients will receive medical evaluation at first meeting, during their treatment and after conclusion of the treatment with physical examination and laboratory tests according to medical criteria.

• Adverse effects will be recorded and managed following the guidelines for immunotherapy and chemotherapy indications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Efficacy, Self
• Hodgkin Disease
• Lymphoma
• Safety Issues

Intervention

Drug:
• low dose nivolumab in combination with AVD
Nivolumab as an standard dose of 40mg in combination with AVD.

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. Ef — View Citation

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 De — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response duration	To evaluate the duration of the response achieved with the therapy.	up to 2 years
Secondary	Adverse effects	To record the side effects associated with the treatment as stablished by the international guidelines for chemotherapy and immunotherapy.	through the study completion and up to 6 months