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Hodgkin LymphomaPhase 2GHSG-AFM13NCT02321592

GHSG-AFM13 An Open-label, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma

A Phase 2 study testing AFM13 in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.

Completed

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

Official record
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Trial summary

The study is designed to demonstrate efficacy of AFM13 with an optimized treatment schedule to decide whether AFM13 warrants further investigation in a phase III clinical trial Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
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
23 participants
Where
1 siteGermany
Study dates
May 2015to Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Patients with diagnosis of classical HL reconfirmed by histopathology and relapsed or refractory disease after standard therapy including brentuximab vedotin and anti-PD1 or PD-L1 antibodies
  • Age: 18 years or older (both genders)
  • ECOG performance status ≤2
  • Life expectancy >3 months
  • Measurable site of disease with ≥ 1.5cm diameter which is evaluable by CT/MRI and FDG-avid by PET
  • Completion of, if applicable, radiotherapy, chemotherapy, antibodies and immunoconjugates including brentuximab vedotin and/or another investigational drug which could interact with this trial not less than 4 weeks (or 5 half-lifes of the drug, whatever occurs later) prior to first dose of study drug
  • Completion of, if applicable, an autologous stem cell transplantation (ASCT) at least 3 months prior tofirst dose of study drug
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

Who cannot join

  • Any significant diseases (other than HL) or clinically significant findings including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participation in the study such as
  • unstable angina pectoris, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ≤ 6 months prior to first study drug, uncontrolled cardiac arrhythmia, cerebrovascular accidents ≤ 6 months before study drug start
  • severely impaired lung function as defined by spirometry (FEV1) and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
  • Liver disease as indicated by AST >3 ULN (> 5 ULN if liver involvement is present)
  • any severe or uncontrolled other disease which might increase the risk associated with study participation or study drug administration and impair the ability to evaluate the patient or for the patient to complete the study
  • Major organ dysfunction (except for HL-related reduced values e.g. in case of bone marrow or organ infiltration) as indicated by
Show all 23Show fewer
  • Absolute Neutrophil Count (ANC) ≤1.5 x 109/l
  • Platelets <75 x 109/l
  • Hemoglobin level ≤9.0 g/dl (may be maintained by transfusions)
  • Total bilirubin >2 ULN (if >2 ULN direct bilirubin is required and should be ≤1.5 x ULN); Alkaline Phosphatase >3 ULN, AST or ALT ≥3 ULN (unless due to Hodgkin Lymphoma or diagnosed Gilbert´s Syndrome)
  • Blood creatinine level >2.0 mg/dl
  • History of a previous malignancy ≤3 years prior to first dose of study drug except basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or completely resected melanoma in stage TNMpT1
  • Patients with a history of HIV seropositivity, chronic active hepatitis, or another uncontrolled active infection within 4 weeks prior to first dose of study drug
  • Patients with evidence of current central nervous system (CNS) involvement
  • Prior allogeneic stem cell transplantation (SCT)
  • Patients receiving systemic corticosteroid treatment > 10 mg daily prednisone equivalents or other chronic systemic immunosuppressive agents within 2 weeks prior to first dose of study drug or during study treatment
  • Major surgery within 4 weeks prior to first dose of study drug
  • Known hypersensitivity to recombinant proteins or any excipient in the drug formulation
  • General intolerance of any protocol medication including obligatory concomitant medication
  • Pregnant or nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter. Male patients not willing to ensure that during the study and at least 3 months thereafter no fathering takes place
  • Patient´s lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
  • Patients unwilling to comply with the protocol
  • Patients who have a relationship of dependence or employer-employee relationship to the sponsor or the investigator

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • 1st Department of Medicine, Cologne University Hospital

    Cologne

Other trials in Germany

About this study

Official title: GHSG-AFM13 An Open-label, Randomized, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma

The study is designed

  • to demonstrate efficacy of AFM13 with an optimized treatment schedule
  • to decide whether AFM13 warrants further investigation in a phase III clinical trial
Being tested
AFM13
Keywords
Hodgkin Lymphoma, AFM13, Natural Killer Cells
Medical subject headings
Hodgkin Disease

What participants receive

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

  • AFM13Drug

Study groups in NCT02321592
Study groupRoleWhat they receive
Arm AActive comparatorAFM13 is administered three times a week (e.g. monday-wednesday-friday) for 8 consecutive weeks. Arm A ist closed.
Receives: Drug: AFM13
Arm BActive comparatorAFM13 is administered three times a week (e.g. monday-wednesday-friday) for 2 consecutive weeks followed by a weekly appication 6 consecutive weeks. Arm B is closed.
Receives: Drug: AFM13
Arm CActive comparatorAFM13 is administered for five consecutive days a week as continuous infusion for 8 consecutive weeks
Receives: Drug: AFM13

What is being measured

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

  1. Objective Response Rate (ORR)

    Measured: at week 11

Secondary outcomes (5)

  1. Remission status based on CT/MRI and PET-CT

    Measured: 3 weeks after end of treatment

  2. Progression Free Survival (PFS)

    Measured: 2 years

  3. Overall Survival (OS)

    Measured: 2 years

  4. Adverse events (AEs) including acute treatment-associated toxicities

    Measured: 2 years

  5. Quality of Life (QoL)-score

    Measured: 1 year

Timeline

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

  1. First posted22 Dec 2014 (estimated)
  2. Study startMay 2015
  3. Primary completionNov 2019
  4. Study completionJul 2020

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02321592
Sponsor's protocol ID
Uni-Koeln-1754
Other IDs
2014-004036-19, 2014
Acronym
GHSG-AFM13
Status last verified
Nov 2020
First submitted
17 Dec 2014
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Sasse S, Brockelmann PJ, Momotow J, Plutschow A, Huttmann A, Basara N, Koenecke C, Martin S, Bentz M, Grosse-Thie C, Thorspecken S, de Wit M, Kobe C, Dietlein M, von Tresckow B, Fuchs M, Borchmann P, Engert A. AFM13 in patients with relapsed or refractory classical Hodgkin lymphoma: final results of an open-label, randomized, multicenter phase II trial. Leuk Lymphoma. 2022 Aug;63(8):1871-1878. doi: 10.1080/10428194.2022.2095623. Epub 2022 Jul 18.

    PubMed 35848865

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AFM13 in people with Hodgkin Lymphoma, run by University of Cologne at 1 site in Germany.

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

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective Response Rate (ORR) (time frame: at week 11). 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 NCT02321592, which also lists 1 linked publication.

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 13 Nov 2020.

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