We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified November 2017 by Prof. Dr. Andreas Engert, University of Cologne
Sponsor:
ClinicalTrials.gov Identifier:
NCT02321592
First Posted: December 22, 2014
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Affimed GmbH
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne
  Purpose

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

Condition Intervention Phase
Hodgkin Lymphoma Drug: AFM13 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GHSG-AFM13 An Open-label, Randomized, Multicenter Phase II Trial With AFM13 in Patients With Relapsed or Refractory Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Prof. Dr. Andreas Engert, University of Cologne:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: at week 11 ]

Secondary Outcome Measures:
  • Remission status based on CT/MRI and PET-CT [ Time Frame: 3 weeks after end of treatment ]
  • Progression Free Survival (PFS) [ Time Frame: 2 years ]
  • Overall Survival (OS) [ Time Frame: 2 years ]
  • Adverse events (AEs) including acute treatment-associated toxicities [ Time Frame: 2 years ]
  • Quality of Life (QoL)-score [ Time Frame: 1 year ]

Estimated Enrollment: 39
Study Start Date: May 2015
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A

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

Arm A ist closed.

Drug: AFM13
Active Comparator: Arm B

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
Active Comparator: Arm C
AFM13 is administered for five consecutive days a week as continuous infusion for 8 consecutive weeks
Drug: AFM13

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321592


Contacts
Contact: Michael Fuchs ghsg@uk-koeln.de

Locations
Germany
1st Department of Medicine, Cologne University Hospital Recruiting
Cologne, Germany
Contact: Michael Fuchs       GHSG@uk-koeln.de   
Principal Investigator: Andreas Engert, MD         
Sponsors and Collaborators
University of Cologne
Affimed GmbH
The Leukemia and Lymphoma Society
Investigators
Principal Investigator: Andreas Engert, Prof. University Hospital of Cologne
  More Information

Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
ClinicalTrials.gov Identifier: NCT02321592     History of Changes
Other Study ID Numbers: Uni-Koeln-1754
2014-004036-19 ( EudraCT Number )
First Submitted: December 17, 2014
First Posted: December 22, 2014
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Prof. Dr. Andreas Engert, University of Cologne:
Hodgkin Lymphoma
AFM13
Natural Killer Cells

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases