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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04101331
Ethics application status
Date submitted
20/09/2019
Date registered
24/09/2019
Date last updated
4/12/2020

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 - PTCL (peripheral T cell lymphoma) patients with CD30 expression =10%

Experimental: Cohort B - PTCL (peripheral T cell lymphoma) patients with CD30 expression =1% to <10%

Experimental: Cohort C - TMF (transformed mycosis fungoides) patients with CD30 expression =1%


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
Antitumor activity of AFM13: Independent Review Committee (IRC)-confirmed objective response rate (ORR) - Assessed by the modified Lugano Classification (Cheson, 2014) for Cohorts A and B (PTCL) and after at least 8 weeks from the first assessment as assessed by Olsen Criteria (Olsen, 2011) for Cohort C (TMF)
Timepoint [1] 0 0
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcome [1] 0 0
Antitumor activity of AFM13: Investigator-assessed objective response rate (ORR-2) - Assessed by the modified Lugano Classification (Cheson, 2014) for Cohorts A and B (PTCL) and after at least 8 weeks from the first assessment as assessed by Olsen Criteria (Olsen, 2011) for Cohort C (TMF)
Timepoint [1] 0 0
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcome [2] 0 0
Duration of response to AFM13 (DOR) - Assessed by the modified Lugano Classification (Cheson, 2014) for Cohorts A and B (PTCL) and after at least 8 weeks from the first assessment as assessed by Olsen Criteria (Olsen, 2011) for Cohort C (TMF )
Timepoint [2] 0 0
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcome [3] 0 0
Safety of AFM13 - Number and frequency of Adverse Events, which includes clinical significant abnormal findings in safety laboratory, vital signs and ECG assessments.
Timepoint [3] 0 0
From screening till final study visit (30-37 days after last dose)
Secondary outcome [4] 0 0
Pharmacokinetics (PK) of AFM13 - Cmax (maximum measured concentration of the analyte in plasma)
Timepoint [4] 0 0
During Cycle 1 (each cycle is 56 days)
Secondary outcome [5] 0 0
PK of AFM13 - AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Timepoint [5] 0 0
During Cycle 1 (each cycle is 56 days)
Secondary outcome [6] 0 0
PK of AFM13 - Vss (Volume of distribution at steady state)
Timepoint [6] 0 0
During Cycle 1 (each cycle is 56 days)
Secondary outcome [7] 0 0
PK of AFM13 - t1/2 (Terminal half-life)
Timepoint [7] 0 0
During Cycle 1 (each cycle is 56 days)
Secondary outcome [8] 0 0
Immunogenicity of AFM13 - Maximum change from baseline of anti-drug antibodies (ADA) in blood and their neutralizing potential
Timepoint [8] 0 0
From screening till final study visit (30-37 days after last dose)
Secondary outcome [9] 0 0
Quality of Life (QoL) - QoL as measured by the European Quality of Life 5-dimensional questionnaire (EQ-5D) for Cohorts A and B; and by Skindex-29 for Cohort C
Timepoint [9] 0 0
Through study completion, up to 12 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
Gender
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
Non-randomised trial
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
France
State/province [9] 0 0
Brest
Country [10] 0 0
France
State/province [10] 0 0
La Roche Sur Yon
Country [11] 0 0
France
State/province [11] 0 0
Villejuif
Country [12] 0 0
Germany
State/province [12] 0 0
Essen
Country [13] 0 0
Germany
State/province [13] 0 0
Mainz
Country [14] 0 0
Germany
State/province [14] 0 0
Muenchen
Country [15] 0 0
Italy
State/province [15] 0 0
Bologna
Country [16] 0 0
Italy
State/province [16] 0 0
Brescia
Country [17] 0 0
Italy
State/province [17] 0 0
Meldola
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Italy
State/province [19] 0 0
Ravenna
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Jeonju
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seongnam-si
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Ulsan
Country [24] 0 0
Poland
State/province [24] 0 0
Gdynia
Country [25] 0 0
Poland
State/province [25] 0 0
Kraków
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Petrozavodsk
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Saint Petersburg
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Saratov
Country [29] 0 0
Russian Federation
State/province [29] 0 0
St. Petersburg
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Tula
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Girona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Sevilla
Country [35] 0 0
Turkey
State/province [35] 0 0
Ankara
Country [36] 0 0
Turkey
State/province [36] 0 0
Istanbul
Country [37] 0 0
Turkey
State/province [37] 0 0
Izmir
Country [38] 0 0
Turkey
State/province [38] 0 0
Izmit
Country [39] 0 0
Turkey
State/province [39] 0 0
Samsun
Country [40] 0 0
Turkey
State/province [40] 0 0
Tekirdag
Country [41] 0 0
Turkey
State/province [41] 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 objective 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/show/NCT04101331
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cassandra Choe-Juliak, 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
Sylvia Schwarz, PhD
Address 0 0
Country 0 0
Phone 0 0
+ 49 6221 6743
Fax 0 0
Email 0 0
s.schwarz@affimed.com
Contact person for scientific queries

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