Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

NCT04052997 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: ADCT-301-2012018-002556-32
• Study Type: interventional
• Target: 117
• Locations: 11 countries
• Sites: 73

Brief Summary

The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).

Conditions

Relapsed Hodgkin Lymphoma; Refractory Hodgkin Lymphoma

Keywords

Camidanlumab Tesirine; Relapsed or Refractory Hodgkins Lymphoma; Classical Hodgkins Lymphoma; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR according to the 2014 Lugano classification as determined by central review in all-treated participants.ORR will be defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Data from the All-treated Population.

  Up to 3 years

Secondary Outcomes (39)

• Duration of Response (DOR)

  Up to 3 years

• CR Rate

  Up to 3 years

• Relapse-Free Survival (RFS)

  Up to 3 years

• Progression-Free Survival (PFS)

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

Study Arms (1)

Camidanlumab Tesirine

EXPERIMENTAL

Camidanlumab Tesirine is administered as a 30- minute intravenous (IV) infusion on Day 1 of each cycle (every 3 weeks). Camidanlumab Tesirine will be administered at a dose of 45 μg/kg every 3 weeks for 2 cycles, then 30 μg/kg for subsequent cycles.

Drug: Camidanlumab Tesirine

Interventions

Camidanlumab Tesirine DRUG

Intravenous Infusion

Also known as: ADCT-301

Camidanlumab Tesirine

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:

• Written informed consent must be obtained prior to any procedures.
• Male or female participant aged 18 years or older. (16 years or older at US based sites)
• Pathologic diagnosis of classical Hodgkin lymphoma (cHL).
• Patients with relapsed or refractory cHL, who have received at least 3 prior lines of systemic therapy (or at least 2 prior lines in HSCT ineligible patients) including brentuximab vedotin and a checkpoint inhibitor approved for cHL (e.g., nivolumab or pembrolizumab). Note 1: Receipt of HSCT to be included in the number of prior therapies needed to meet eligibility.
• Measurable disease as defined by the 2014 Lugano Classification.
• Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available).
• Note 1: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.
• Note 2: If a sufficient amount of tissue is not available, a fresh biopsy may be taken, provided the procedure is not deemed high-risk and is clinically feasible, and provided it is approved locally.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Adequate organ function as defined by Screening laboratory values within the following parameters:
• Absolute neutrophil count (ANC) ≥ 1.0 × 103/μL (off growth factors at least 72 h).
• Platelet count ≥ 75 × 103/μL without transfusion in the past 2 weeks.
• ALT, AST, or GGT ≤ 2.5 × the upper limit of normal (ULN) if there is no liver involvement; ALT or AST ≤ 5 × ULN if there is liver involvement.
• Total bilirubin ≤ 1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤ 3 × ULN with direct bilirubin ≤ 1.5 × ULN).
• Blood creatinine ≤ 3.0 × ULN or calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault equation.

You may not qualify if:

• Previous treatment with Camidanlumab Tesirine.
• Participation in another investigational interventional study. Being in follow-up of another investigational study is allowed.
• Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a CD25 antibody.
• Allogenic or autologous transplant within 60 days prior to start of study drug.
• Active graft-versus-host disease (GVHD), except for non-neurologic symptoms as a manifestation of mild (≤ Grade 1) chronic GVHD.
• Post-transplantation lymphoproliferative disorders.
• History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]) (subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).
• History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system autoimmune disease (e.g., poliomyelitis, multiple sclerosis).
• History of recent infection (within 4 weeks of Cycle 1, Day 1 \[C1D1\]) considered to be caused by one of the following pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
• Note: An influenza test and a pathogendirected SARS CoV-2 test (such as polymerase chain reaction) are mandatory and must be negative before initiating study treatment (tests to be performed 3 days or less prior to dosing on C1D1; an additional 2 days are allowed in the event of logistical issues for receiving the results on time).
• Participants known to be or having been infected with human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV), and require anti-viral therapy or prophylaxis. Note: Serology testing is mandatory for patients with unknown status.
• History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Failure to recover ≤ Grade 1 (Common Terminology Criteria for Adverse Events version 4.0 \[CTCAE v4.0\]) from acute non-hematologic toxicity (except ≤ Grade 2 neuropathy or alopecia), due to previous therapy, prior to screening.
• Hodgkin lymphoma (HL) with central nervous system involvement, including leptomeningeal disease.
• Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).

Sponsors & Collaborators

• ADC Therapeutics S.A.: lead

Study Sites (73)

Mayo Clinic - Arizona

Scottsdale, Arizona, 85259, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

UCSF Health - Hematology and Blood and Marrow Transplant Clinic

San Francisco, California, 94143, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Northside Hospital - Atlanta

Atlanta, Georgia, 30342, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Norton Cancer Institute - Saint Matthews

Louisville, Kentucky, 40207, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine in Saint Louis

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan-Kettering Cancer Center - New York

New York, New York, 10065, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-9452, United States

Location

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic - Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 40207, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

Bruges, 8000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Grand Hôpital de Charleroi - Notre Dame

Charleroi, 6000, Belgium

Location

Hôpital de Jolimont

La Louvière, Belgium

Location

Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

Yvoir, B-5530, Belgium

Location

British Columbia Cancer Agency

Vancouver, British Columbia, BC V5Z 4E6, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, V5Z 4E6, Canada

Location

Fakultní Nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultní Nemocnice Královské Vinohrady

Prague, 100 34, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Hôpitaux Universitaires Henri Mondor

Créteil, 94000, France

Location

Hôpital François Mitterrand

Dijon, 21000, France

Location

Clinique Victor Hugo Le Mans

Le Mans, 72000, France

Location

Hôpital Saint-Eloi

Montpellier, 34295, France

Location

Hôpital Haut-Lévêque

Pessac, 33604, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

Rouen, 76038, France

Location

Universitätsklinikum Halle

Halle, 06120, Germany

Location

Debreceni Egyetem Klinikai Központ

Debrecen, 4032, Hungary

Location

Pécsi Tudományegyetem

Pécs, 7624, Hungary

Location

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria

Alessandria, 15121, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

Bologna, 40138, Italy

Location

Istituto Clinico Humanitas

Milan, 20089, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, 80100, Italy

Location

Istituto Oncologico Veneto - IRCCS

Padua, 35128, Italy

Location

Szpital Wojewódzki w Opolu

Opole, 45-061, Poland

Location

Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

Wroclaw, Poland

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

Barcelona, 08908, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Quirónsalud Madrid

Pozuelo de Alarcón, 28223, Spain

Location

Complejo Asistencial Universitario de Salamanca - Hospital Clínico

Salamanca, 37007, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

NHS Greater Glasgow and Clyde

Glasgow, G12 0YN, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

Location

University Hospitals Plymouth NHS Trust

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (1)

• Herrera AF, Ansell SM, Zinzani PL, Radford J, Maddocks K, Pinto A, Collins GP, Bachanova V, Bartlett NL, Bence-Bruckler I, Hamadani M, Kline J, Mayer J, Savage KJ, Advani RH, Caimi PF, Casasnovas RO, Feldman T, Hess B, Bastos-Oreiro M, Iyengar S, Szomor A, Townsend W, Andre M, Dyczkowski J, Havenith K, Toukam M, Pantano S, Cruz HG, Wang L, Negievich Y, Lucero M, Wuerthner J, Carlo-Stella C. Camidanlumab tesirine for relapsed or refractory classic Hodgkin lymphoma: a phase 2 study. Blood Adv. 2025 Dec 9;9(23):6205-6217. doi: 10.1182/bloodadvances.2024015600.

  PMID: 40811783 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Recurrence; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trials Information
• Organization: ADC Therapeutics SA

clinical.trials@adctherapeutics.com

954-903-7994

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 12, 2019
• Study Start: September 13, 2019
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: March 28, 2024
• Results First Posted: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3); CA (3); IT (5); PL (2); DE (1); ES (14); HU (2); BE (5); FR (8); US (24); GB (6)