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Peripheral T Cell LymphomaPhase 2REDIRECTNCT04101331

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

A Phase 2 study testing AFM13 in people with Peripheral T Cell Lymphoma and Transformed Mycosis Fungoides, run by Affimed GmbH at 69 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AFM13
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
69 sitesin 10 countries
Study dates
13 Nov 2019to 11 Jan 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

69 sites in 10 countries.

69 sites in 10 countries

United States13 sites

  • University of Michigan Health | Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory University Clinic/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

    Birmingham, Alabama, 35294

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California Los Angeles (UCLA) Health

    Los Angeles, California, 90404

  • Ochsner Clinic Foundation/Precision Cancer Therapies Program

    New Orleans, Louisiana, 70121

  • Center for Lymphoid Malignancies

    New York, New York, 10019

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Washington Seattle Cancer Care Alliance

    Seattle, Washington, 98109

Other trials in United States

Spain10 sites

  • Duran I Reynals Hospital Catalan Institute Of Oncology

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol

    Barcelona

  • Institut Catala d' Oncologia Girona

    Girona

  • Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

    Madrid

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario Virgen del Rocio

    Seville

  • Institut Catala d'Oncologia Tarragona

    Tarragona

Other trials in Spain

Turkey (Türkiye)10 sites

  • Ankara University Faculty of Medicine, Department of Internal Diseases, Hematology Division

    Ankara

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim Arastirma Hastanesi Hematoloji Klinigi Ankara

    Ankara

  • Gazi University Faculty of Medicine, Department of Internal Diseases

    Ankara

  • Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırm Hastanesi

    Ankara

  • Istanbul Universitesi Istanbul Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali Fatih

    Istanbul

  • Ege University Medical Faculty

    Izmir

  • Kocaeli University Faculty of Medicine, Department of Internal Diseases, Hematology Division

    İzmit

  • Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Egitim Merkezi

    Samsun

  • Tekirdag Namik Kemal Universitesi Saglik Uygulama ve Arastirma Hastanesi

    Tekirdağ

  • KaradenizTeknik Universitesi Tip Fakultesi Farabi Hastanesi

    Trabzon

Other trials in Turkey (Türkiye)

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide

  • Flinders Medical Centre

    Bedford Park

  • Monash Health-Monash Medical Centre

    Clayton

  • Concord Repatriation General Hospital

    Concord

  • Gosford Hospital

    Gosford

  • Linear Clinical Research

    Nedlands

Other trials in Australia

Russia6 sites

  • Republic Hospital n.a. V.A. Baranov

    Petrozavodsk

  • First State Saint-Petersburg Pavlov Medical University

    Saint Petersburg

  • GUZ Leningrad Regional Clinical Hospital

    Saint Petersburg

  • Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

    Saint Petersburg

  • Saratov State Medical University

    Saratov

  • Regional Clinical Hospital

    Tula

Other trials in Russia

France5 sites

  • Centre Hospitalier Universitaire (CHU) de Bordeaux

    Bordeaux

  • Centre Hospitalier Universitaire de Brest

    Brest

  • CHD Vendée

    La Roche-sur-Yon

  • CHU Pontchaillou

    Rennes

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Italy5 sites

  • Ist.Ematologia E Oncologia Medica L.E A.Seragnoli

    Bologna

  • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

    Brescia

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

    Meldola

  • Azienda Ospedaliera Niguarda Ca' Granda

    Milan

  • Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna

    Ravenna

Other trials in Italy

Poland5 sites

  • Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial Hematologii i Transplantologii Szpiku

    Gdynia

  • Pratia MCM Krakow

    Krakow

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

    Warsaw

  • Instytut Hematologii i Transfuzjologii, Klinika Hematologii

    Warsaw

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

    Wroclaw

Other trials in Poland

South Korea5 sites

  • Chonbuk National University Hospital

    Jeonju

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

Germany4 sites

  • Kliniken Essen Sued - Evangelisches Krankenhaus Essen-Werden gGmbH

    Essen

  • University Hospital Leipzig

    Leipzig

  • Universitaetsmedizin Mainz

    Mainz

  • Rotkreuzklinikum Muenchen

    München

Other trials in Germany

About this study

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)

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).

Read more

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.

Being tested
AFM13
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

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

  • AFM13Drug

    weekly intravenous infusions of 200mg

Study groups in NCT04101331
Study groupRoleWhat they receive
Cohort AExperimentalSubjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Receives: Drug: AFM13

What is being measured

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

  1. 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).

    Measured: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).

Secondary outcomes (16)

  1. 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).

    Measured: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

  2. 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).

    Measured: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

  3. 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).

    Measured: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

  4. 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).

    Measured: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

  5. 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).

    Measured: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

  6. 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).

    Measured: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

  7. Duration of Overall Response Assessed by Investigator 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 the investigator.

    Measured: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

  8. Duration of Overall Response Assessed by Investigator 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 the investigator.

    Measured: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

  9. Number of Subjects With Treatment Related Adverse Event

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

    Measured: From the date of first treatment until the date of the last treatment + 37 days, up to 199 weeks.

  10. Maximum Measured Concentration (Cmax) of AFM13

    Maximum measured concentration (Cmax) of the AFM13 in serum. Geometric coefficient of variation is given in percentages.

    Measured: Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.

  11. 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 serum over time interval from 0 extrapolated to infinity.

    Geometric coefficient of variation is given in percentages.

    Measured: Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.

  12. Volume of Distribution at Steady State (Vss) of AFM13

    Volume of distribution at steady state (Vss) of the AFM13. Geometric coefficient of variation is given in percentages.

    Measured: Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 29.

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

    The terminal half-life (t1/2) of the AFM13. Geometric coefficient of variation is given in percentages.

    Measured: Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.

  14. 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.

    Measured: At baseline and final study visit, up to 199 weeks.

  15. 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. A negative outcome indicates a decrease in score compared to the baseline value.

    Measured: From baseline until final study visit, up to 199 weeks.

  16. Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment

    Number of subjects who had treatment (AFM13) and developed anti-drug antibodies (ADA).

    Measured: Pre-dose Day 1 on cycle 1 and end of treatment, up to approximately 46 months.

Timeline

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

  1. First posted24 Sep 2019
  2. Study start13 Nov 2019
  3. Primary completion11 May 2022
  4. Study completion11 Jan 2024

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
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04101331
Sponsor's protocol ID
AFM13-202
Acronym
REDIRECT
Status last verified
Nov 2024
First submitted
20 Sep 2019
Last updated
5 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AFM13 in people with Peripheral T Cell Lymphoma and Transformed Mycosis Fungoides, run by Affimed GmbH at 69 sites in 10 countries.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Spain, Turkey (Türkiye), Australia, Russia and 5 more countries. 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?

Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate Assessed by Independent Review Committee Based on PET-CT (time frame: Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).). 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 NCT04101331.

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 5 Nov 2024.

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