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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04101331




Registration number
NCT04101331
Ethics application status
Date submitted
20/09/2019
Date registered
24/09/2019
Date last updated
5/11/2024

Titles & IDs
Public title
Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
Scientific 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)
Secondary ID [1] 0 0
AFM13-202
Universal Trial Number (UTN)
Trial acronym
REDIRECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral T Cell Lymphoma 0 0
Transformed Mycosis Fungoides 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AFM13

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


Treatment: Drugs: AFM13
weekly intravenous infusions of 200mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate Assessed by Independent Review Committee Based on PET-CT
Timepoint [1] 0 0
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
Secondary outcome [1] 0 0
Overall Response Rate Assessed by Investigator Based on PET-CT
Timepoint [1] 0 0
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
Secondary outcome [2] 0 0
Overall Response Rate Assessed by Investigator Based on CT
Timepoint [2] 0 0
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
Secondary outcome [3] 0 0
Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT
Timepoint [3] 0 0
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
Secondary outcome [4] 0 0
Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT
Timepoint [4] 0 0
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
Secondary outcome [5] 0 0
Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT
Timepoint [5] 0 0
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
Secondary outcome [6] 0 0
Duration of Overall Response Assessed by Independent Review Committee Based on CT
Timepoint [6] 0 0
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
Secondary outcome [7] 0 0
Duration of Overall Response Assessed by Investigator Based on PET-CT
Timepoint [7] 0 0
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
Secondary outcome [8] 0 0
Duration of Overall Response Assessed by Investigator Based on CT
Timepoint [8] 0 0
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
Secondary outcome [9] 0 0
Number of Subjects With Treatment Related Adverse Event
Timepoint [9] 0 0
From the date of first treatment until the date of the last treatment + 37 days, up to 199 weeks.
Secondary outcome [10] 0 0
Maximum Measured Concentration (Cmax) of AFM13
Timepoint [10] 0 0
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.
Secondary outcome [11] 0 0
Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-8)
Timepoint [11] 0 0
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.
Secondary outcome [12] 0 0
Volume of Distribution at Steady State (Vss) of AFM13
Timepoint [12] 0 0
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.
Secondary outcome [13] 0 0
The Terminal Half-life (t1/2) of AFM13
Timepoint [13] 0 0
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.
Secondary outcome [14] 0 0
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Timepoint [14] 0 0
At baseline and final study visit, up to 199 weeks.
Secondary outcome [15] 0 0
European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)
Timepoint [15] 0 0
From baseline until final study visit, up to 199 weeks.
Secondary outcome [16] 0 0
Number of Subjects Who Developed Anti-drug Antibodies (ADA) During Treatment
Timepoint [16] 0 0
Pre-dose Day 1 on cycle 1 and end of treatment, up to approximately 46 months.

Eligibility
Key inclusion criteria
Main

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/01/2024
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Monash Health-Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [5] 0 0
Gosford Hospital - Gosford
Recruitment hospital [6] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bedford Park
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Concord
Recruitment postcode(s) [5] 0 0
- Gosford
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
France
State/province [11] 0 0
Bordeaux
Country [12] 0 0
France
State/province [12] 0 0
Brest
Country [13] 0 0
France
State/province [13] 0 0
La Roche Sur Yon
Country [14] 0 0
France
State/province [14] 0 0
Rennes
Country [15] 0 0
France
State/province [15] 0 0
Villejuif
Country [16] 0 0
Germany
State/province [16] 0 0
Essen
Country [17] 0 0
Germany
State/province [17] 0 0
Leipzig
Country [18] 0 0
Germany
State/province [18] 0 0
Mainz
Country [19] 0 0
Germany
State/province [19] 0 0
Muenchen
Country [20] 0 0
Italy
State/province [20] 0 0
Bologna
Country [21] 0 0
Italy
State/province [21] 0 0
Brescia
Country [22] 0 0
Italy
State/province [22] 0 0
Meldola
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Italy
State/province [24] 0 0
Ravenna
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Jeonju
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seongnam-si
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Ulsan
Country [29] 0 0
Poland
State/province [29] 0 0
Gdynia
Country [30] 0 0
Poland
State/province [30] 0 0
Kraków
Country [31] 0 0
Poland
State/province [31] 0 0
Warsaw
Country [32] 0 0
Poland
State/province [32] 0 0
Wroclaw
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Petrozavodsk
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Saint Petersburg
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Saratov
Country [36] 0 0
Russian Federation
State/province [36] 0 0
St. Petersburg
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Tula
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Girona
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Sevilla
Country [42] 0 0
Spain
State/province [42] 0 0
Tarragona
Country [43] 0 0
Turkey
State/province [43] 0 0
Ankara
Country [44] 0 0
Turkey
State/province [44] 0 0
Istanbul
Country [45] 0 0
Turkey
State/province [45] 0 0
Izmir
Country [46] 0 0
Turkey
State/province [46] 0 0
Izmit
Country [47] 0 0
Turkey
State/province [47] 0 0
Samsun
Country [48] 0 0
Turkey
State/province [48] 0 0
Tekirdag
Country [49] 0 0
Turkey
State/province [49] 0 0
Trabzon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Affimed GmbH
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04101331
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karenza Alexis, MD
Address 0 0
Affimed Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04101331