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Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

Primary Purpose

Peripheral T Cell Lymphoma, Transformed Mycosis Fungoides

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AFM13

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

Histologically confirmed CD30-positive PTCL (most subtypes allowed) or TMF per the revised World Health Organization 2016 classification (Swerdlow, 2016) by central assessment.
Cohorts A and B (PTCL cohorts): measurable by the modified Lugano Classification (Cheson, 2014); measurable disease of ≥1.5 cm diameter by computed tomography (CT), assessed locally for eligibility. Note: fluorodeoxyglucose (FDG) avid disease by positron emission tomography (PET) recommended, if possible.
Cohort C (TMF cohort): measurable by the Olsen Criteria (Olsen, 2011) including at least 1 cutaneous lymphoma lesion ≥2 cm in diameter, assessed locally for eligibility.
Patients must have relapsed or refractory disease AND the following:
Cohorts A and B (PTCL): patients must have received at least 1 prior line of systemic therapy. For patients with systemic ALCL, patients must have failed or be intolerant to brentuximab vedotin [BV]; Adcetris®
Cohort C (TMF): patients must have received at least 1 prior line of systemic therapy; and have exhausted systemic therapies with regular approval for their disease

Main Exclusion Criteria:

Patients with the following subtypes of lymphoma: T-cell prolymphocytic leukemia; T-cell large granular lymphocytic leukemia; Chronic lymphoproliferative disorder of NK cells; Aggressive NK-cell leukemia; Extranodal NK-/T-cell lymphoma; Indolent T-cell lymphoproliferative disorder of the GI tract:
Has had an allogenic tissue hematopoietic cell/solid organ transplant within the last 3 years. Note: Patients who have had a transplant >3 years ago are eligible as long as there are no signs/symptoms of graft versus host disease (GvHD).
Requirement for systemic immunosuppressive therapy, e.g. GvHD therapy, <12 weeks prior to the first dose of study drug.
Prior treatment with AFM13

Sites / Locations

University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)
City of Hope Comprehensive Cancer Center
University of California Los Angeles (UCLA) Health
Emory University Clinic/Winship Cancer Institute
Ochsner Clinic Foundation/Precision Cancer Therapies Program
University of Michigan Health | Rogel Cancer Center
Mayo Clinic
Center for Lymphoid Malignancies
Memorial Sloan Kettering Cancer Center
Abramson Cancer Center of the University of Pennsylvania
University of Pittsburgh Medical Center
MD Anderson Cancer Center
University of Washington Seattle Cancer Care Alliance
Royal Adelaide Hospital
Flinders Medical Centre
Monash Health-Monash Medical Centre
Concord Repatriation General Hospital
Gosford Hospital
Linear Clinical Research
Centre Hospitalier Universitaire (CHU) de Bordeaux
Centre Hospitalier Universitaire de Brest
CHD Vendée
CHU Pontchaillou
Institut Gustave Roussy
Kliniken Essen Sued - Evangelisches Krankenhaus Essen-Werden gGmbH
University Hospital Leipzig
Universitaetsmedizin Mainz
Rotkreuzklinikum Muenchen
Ist.Ematologia E Oncologia Medica L.E A.Seragnoli
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Azienda Ospedaliera Niguarda Ca' Granda
Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna
Chonbuk National University Hospital
Seoul National University Bundang Hospital
Catholic University of Korea, Seoul St. Mary's Hospital
Samsung Medical Center
Ulsan University Hospital
Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial Hematologii i Transplantologii Szpiku
Pratia MCM Krakow
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
Republic Hospital n.a. V.A. Baranov
First State Saint-Petersburg Pavlov Medical University
Saratov State Medical University
GUZ Leningrad Regional Clinical Hospital
Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency
Regional Clinical Hospital
Duran I Reynals Hospital Catalan Institute Of Oncology
Hospital de la Santa Creu i Sant Pau
Hospital del Mar
Hospital Universitari Vall d'Hebron
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Institut Catala d' Oncologia Girona
Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias
Hospital Universitario Fundacion Jimenez Diaz
Hospital Universitario Virgen del Rocio
Institut Catala d'Oncologia Tarragona
Ankara University Faculty of Medicine, Department of Internal Diseases, Hematology Division
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim Arastirma Hastanesi Hematoloji Klinigi Ankara
Gazi University Faculty of Medicine, Department of Internal Diseases
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırm Hastanesi
Istanbul Universitesi Istanbul Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali Fatih
Ege University Medical Faculty
Kocaeli University Faculty of Medicine, Department of Internal Diseases, Hematology Division
Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Egitim Merkezi
Tekirdag Namik Kemal Universitesi Saglik Uygulama ve Arastirma Hastanesi
KaradenizTeknik Universitesi Tip Fakultesi Farabi Hastanesi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort A

Arm Description

Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).

Outcomes

Primary Outcome Measures

Overall Response Rate Assessed by Independent Review Committee Based on PET-CT

Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).

Secondary Outcome Measures

Overall Response Rate Assessed by Investigator Based on PET-CT

Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).

Overall Response Rate Assessed by Investigator Based on CT

Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).

Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT

Complete response and/or partial response by Positron Emission Tomography-Computed Tomography (PET-CT) assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).

Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT

Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).

Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT

Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Positron Emission Tomography-Computed Tomography (PET-CT) by Independent Review Committee (IRC).

Duration of Overall Response Assessed by Independent Review Committee Based on CT

Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Computed Tomography (CT) by Independent Review Committee (IRC).

Duration of Overall Response Assessed by Investigator Based on PET-CT

Duration of Overall Response Assessed by Investigator Based on CT

Number of Subjects With Treatment Related Adverse Event

Number of subjects who had treatment (AFM13) related Adverse Events.

Maximum Measured Concentration (Cmax) of AFM13

Maximum measured concentration (Cmax) of the AFM13 in plasma.

Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)

Area under concentration (AUC) versus time curve of the AFM13 in plasma over time interval from 0 extrapolated to infinity.

Volume of Distribution at Steady State (Vss) of AFM13

Volume of distribution at steady state (Vss) of the AFM13.

The Terminal Half-life (t1/2) of AFM13

The terminal half-life (t1/2) of the AFM13.

European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)

Quality of Life (QoL) as measured by the European QoL 5-dimensional questionnaire (EQ-5D) for Cohorts A. The EQ-5D comprises asks for the current health state in the five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Pain/discomfort scores assessed based on questionnaire. The categories of the response offer three levels pain/discomfort score: "no pain or discomfort" (score of 1), "moderate pain or discomfort" (score of 2), and "extreme pain and discomfort" (score of 3). Scores are presented from baseline to each visit for Cohort A.

European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)

Quality of Life (QoL) as measured by the European Quality of Life 5-dimensional questionnaire (EQ-5D) for Cohorts A. Visual Analogue Scale scores assessed based on drawn scale from 0(worst imaginable state) to 100(best imaginable state). Subjects chose their health state on scale based on their situation by themselves.

Full Information

NCT ID

NCT04101331

First Posted

September 20, 2019

Last Updated

August 7, 2023

Sponsor

Affimed GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04101331

Brief Title

Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides

Acronym

REDIRECT

Official Title

A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 13, 2019 (Actual)

Primary Completion Date

May 11, 2022 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Affimed GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies. Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of overall responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood. Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T Cell Lymphoma, Transformed Mycosis Fungoides

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A

Arm Type

Experimental

Arm Description

Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).

Intervention Type

Drug

Intervention Name(s)

AFM13

Intervention Description

weekly intravenous infusions of 200mg

Primary Outcome Measure Information:

Title

Overall Response Rate Assessed by Independent Review Committee Based on PET-CT

Description

Time Frame