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Safety IssuesPhase 2NCT05772624

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

A Phase 2 study testing low dose nivolumab in combination with AVD in people with Safety Issues and Efficacy, Self, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Safety Issues, Efficacy, Self
What is being tested?
low dose nivolumab in combination with AVD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteMexico
Study dates
13 Feb 2023to 1 Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

David Gomez Almaguer, MD contact

+52 8183486136

dgomezalmaguer@gmail.com

Mexico1 site, 1 recruiting

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

    Perla R Colunga Pedraza, MD, +52 8183486136, colunga.perla@gmail.com

    Antonio Vega Mateos, MD, +52 8183488510, antoniovegamat@gmail.com

    Recruiting

Other trials in Mexico

About this study

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

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.

Read the detailed 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.
Being tested
low dose nivolumab in combination with AVD
Keywords
Nivolumab, lowdose nivolumab, NAVD, hodgkin's lymphoma
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low dose nivolumab in combination with AVDDrug

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

Study groups in NCT05772624
Study groupRoleWhat they receive
LowN-AVDExperimentalclassic Hodgkin's lymphoma patients receiving low dose nivolumab in combination with AVD
Receives: Drug: low dose nivolumab in combination with AVD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine general response

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

    Measured: Six weeks after completion of therapy.

Secondary outcomes (2)

  1. Response duration

    To evaluate the duration of the response achieved with the therapy.

    Measured: up to 2 years

  2. Adverse effects

    To record the side effects associated with the treatment as stablished by the international guidelines for chemotherapy and immunotherapy.

    Measured: through the study completion and up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start13 Feb 2023
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05772624
Sponsor's protocol ID
HE23-0001
Status last verified
Mar 2023
First submitted
13 Feb 2023
Last updated
16 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28434018

  • 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.

    PubMed 33062947

  • 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.

    PubMed 32352505

  • 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.

    PubMed 32786092

  • 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.

    PubMed 31112476

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing low dose nivolumab in combination with AVD in people with Safety Issues and Efficacy, Self, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David Gomez Almaguer, MD (+52 8183486136, dgomezalmaguer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine general response (time frame: Six weeks after completion of therapy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05772624, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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