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

NCT02321592 | Completed Phase 2 DMC

• 2 other identifiers: Uni-Koeln-17542014-004036-19
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma; AFM13; Natural Killer Cells

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  at week 11

Secondary Outcomes (5)

• Remission status based on CT/MRI and PET-CT

  3 weeks after end of treatment

• Progression Free Survival (PFS)

  2 years

• Overall Survival (OS)

  2 years

• Adverse events (AEs) including acute treatment-associated toxicities

  2 years

• Quality of Life (QoL)-score

  1 year

Study Arms (3)

Arm A

ACTIVE COMPARATOR

AFM13 is administered three times a week (e.g. monday-wednesday-friday) for 8 consecutive weeks. Arm A ist closed.

Drug: AFM13

Arm B

ACTIVE COMPARATOR

AFM13 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.

Drug: AFM13

Arm C

ACTIVE COMPARATOR

AFM13 is administered for five consecutive days a week as continuous infusion for 8 consecutive weeks

Drug: AFM13

Interventions

AFM13 DRUG

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Cologne: lead
• Affimed GmbH: collaborator
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

Location

Related Publications (1)

• 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, Tresckow BV, 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.

  PMID: 35848865 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

AFM13

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Andreas Engert, Prof.

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: May 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: July 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

DE (1)