Neoplasms

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Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

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Lymphatic Diseases

Immunoproliferative Disorders

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Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Pembrolizumab

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunotoxins

Immunoconjugates

Immunologic Factors

Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles

Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1

Brentuximab Vedotin 50 MG [Adcetris]

Lauro Fabián Amador, PhD

JUAN Ojeda Tovar, MD

Lauro F Amador, Researcher

Lauro Amador Medina

The choice of the best second-line therapy in patients with high LH R/R risk, it is a niche of knowledge not covered at the moment, especially the role of Brentuximab (BV) plus PD-1 blockade and auto-HSCT.

What is the progression-free survival and rate of metabolic responses complete in patients with high-risk R/R HL with the treatment strategy: BV+ PD-1 blockade consolidation with Auto-HSCT and maintenance with BV + PD-blockade

1?

Patientes with Refractory/relapsed Hodgkin Lymphoma (HL R/R) with multiple failed therapies represent a therapeutic dilemma. The goal of next-line treatment is long-term disease control with manageable adverse reactions. Given the limited therapeutic options for patients with HL R/R, better therapies should be sought, more effective, with better tolerability, less toxicity, with increased overall survival (OS) of the patients, with the aim of improving outcomes in terms of disease-free survival progression (PFS) of the current standard treatment. Since currently only 50% of the patients with high-risk R/R HL treated with the standard regimen achieve healing. The high effectiveness and low toxicity of immunotherapy with prolonged remission or stabilization of the disease make it a new treatment option promising for HL R/R. Based on the above, a treatment strategy is proposed to rescue base with Brentuximab plus PD-1 blockade followed by autotransplantation and consolidation with Brentuximab plus PD-1 blockade in patients with Hodgkin lymphoma High-Risk Relapse/Refractory Compared to Reported OS and PFS Rates in the literature obtained with standard treatment.

Brentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cycles

Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Rescue With Brentuximab Plus PD-1 Blockade Followed by Autotransplantation and Consolidation With Brentuximab Plus PD-1 Blockade in Patients With Relapsed/Refractory Hodgkin Lymphoma: Exploratory Single-arm Analysis

We have plan to share participant data for metanalysis

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.

complete absence of any disease assessed by PET after established treatment

Universidad de Guanajuato

Hospital Regional de Alta Especialidad del Bajio

Principal Investigator

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma, Non-Hodgkin

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Subjects will receive the study drug Isatuximab in addition to standard procedures for transplant

Subjects will receive standard procedures for transplant.

Isatuximab

Standard procedures (standard of care) for transplant

Standard Procedures

Research Nurse Navigator

Divaya Bhutani, MD

Divaya Bhutani

The purpose of this study is to see if Isatuximab can alter the immune system in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. The investigators will see if Isatuximab makes changes to the immune system so that upon recovery from the transplant, the immune system can fight the cancer. This study will have two arms. On one arm (control arm), participants will receive standard transplant procedures and on the other arm (experimental arm), participants will receive Isatuximab in addition to the standard transplant procedures. The assignment to these arms is done randomly (determined by chance, like flipping a coin) by a computer. Each participant will have about 66% chance of getting on the experimental arm and about 33% chance of getting on the control arm.

Relapse post-autologous stem cell transplantation (ASCT) remains a major challenge in the treatment of multiple myeloma (MM) and Lymphoma. The immune reconstitution post-ASCT has a major impact on the outcomes of ASCT, however effective methods to improve upon immune reconstitution have not been developed and the use of novel immunomodulators remains relatively unexplored. In addition, numerous studies have demonstrated the profound impact of graft composition on transplant outcomes, but not a single prospective study has addressed this issue successfully. In this study, the investigators intend to test a novel double pronged method of changing the immune repertoire post ASCT by modifying graft composition and improving effector T cell recovery and function post ASCT. In this study, the investigators intend to generate new information on immune modulation post-ASCT. In addition, the CD38 antibodies have not been evaluated as therapy for B-cell non-Hodgkin Lymphoma (NHL). If this study shows significant immunomodulator activity of this approach, cluster of differentiation 38 (CD38) antibodies could be further evaluated in combination with ASCT in NHL.

Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma

Randomized Phase 2 Trial of Isatuximab During Autologous Stem Cell Collection and Transplantation Period in Patients With Multiple Myeloma, Relapsed Hodgkin's and Non-Hodgkin's Lymphoma

Change in total lymphocyte count measured from blood sample

The number of adverse events recorded for participants using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Percentage of participants with an absolute lymphocyte count of \>500 cells/microliter on Day 30 post transplant

Immune cell phenotyping ( cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) subsets) in the peripheral blood using flow cytometry based analysis

Percentage of activated B and T regulatory cells in the peripheral blood

Percentage of activated helper and effector T cells in the peripheral blood

Percentage of NK cells in the peripheral blood

Genzyme, a Sanofi Company

Assistant Professor of Medicine

Ipilimumab

Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.

* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles

Reid W Merryman, MD

This study is looking at the effects of Ipilimumab when it is given alone or in combination with Nivolumab to patients with relapsed or refractory classic Hodgkin's lymphoma (cHL).

The names of the study drugs involved in this study are:

* Ipilimumab
* Nivolumab

This is an open-label, multi-center, phase II study of ipilimumab with or without nivolumab for patients with relapsed or refractory (R/R) classic Hodgkin lymphoma (cHL).

Nivolumab is a drug which is approved by the United States Food and Drug Administration (FDA) for the treatment of adult patients experiencing relapsed Hodgkin lymphoma (cHL) who have received at least two prior systemic therapies.

Ipilimumab has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced kidney cancers.

The study drugs have not been approved in combination for cHL by the Food and Drug Administration (FDA). This study is for participants who previously had progressive disease when receiving a PD-1 mAb.

Participants will receive 4 cycles of ipilimumab monotherapy and then undergo restaging imaging. Patients who achieved an objective response will continue treatment with ipilimumab maintenance. Other patients will receive 4 cycles of nivolumab and ipilimumab followed by ipilimumab maintenance treatment. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are eligible to proceed to combination therapy with nivolumab and ipilimumab if they are clinically stable. Participants will receive up to \~ 24 months of study treatment.

After completion of therapy, participants will be followed every 3 months for 2 years and then every 6 months for the next 5 years.

It is expected that about 13 people will participate in this research study.

Bristol Myers Squibb (BMS) is supporting this research study by providing the study drugs and funding for the study.

Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL

A Phase II Trial of Ipilimumab With and Without Nivolumab in Patients With Relapsed/Refractory Classic Hodgkin Lymphoma

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Assessed by PET/CT (using Lugano criteria and LYRIC criteria)

Assessed by PET/CT (using Lugano criteria and LYRIC criteria) after ipilimumab monotherapy

Assessed by PET/CT (using Lugano criteria and LYRIC criteria) after 4 ipilimumab monotherapy

Assessed by PET/CT (using Lugano criteria and LYRIC criteria) after ipilimumab and nivolumab combination therapy

Descriptions and grading scales per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma	NCT05595447	Hodgkin Lymphom... Refractory Hodg... Relapsed Hodgki...	Brentuximab Ved...	15 Years - 90 Years	Hospital Regional de Alta Especialidad del Bajio
Isatuximab During Stem Cell Collection and Transplant in Patients With Multiple Myeloma and Lymphoma	NCT05346809	Lymphoma Multiple Myelom... Non-Hodgkin Lym... Relapsed Hodgki...	Isatuximab Standard Proced...	18 Years -	Columbia University
Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL	NCT04938232	Hodgkin Lymphom... Relapsed Hodgki... Refractory Hodg...	Nivolumab Ipilimumab	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for relapsed hodgkin's disease, adult