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Hodgkin LymphomaPhase 1NCT01221571

A Study to Assess AFM13 in Patients With Hodgkin Lymphoma

A Phase 1 study testing AFM 13 in people with Hodgkin Lymphoma, run by Affimed GmbH at 3 sites in 2 countries.

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 aim of this study is to determine the safety, tolerability, pharmacokinetics and activity of single cycles of AFM13 in patients with CD30 positive refractory and/or relapsed Hodgkin lymphoma. 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?
AFM 13
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesin 2 countries
Study dates
Oct 2010to Jun 2013
Phase
Phase 1
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

  • Histological diagnosis of relapsed or refractory Hodgkin lymphoma expressing the CD30 antigen.
  • Age ≥18 years.
  • Both genders.
  • Patients who have relapsed or are refractory after at least two prior potentially curative therapies including autologous stem cell transplantation (ASCT). Patients with a progressive disease after the first-line therapy who are ineligible for, or refused to receive high dose chemotherapy and/or ASCT for the second-line therapy, or any other established curative therapy, are also eligible.
  • Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry.
  • Patients who received ASCT should have fully recovered prior to study entry.
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  • Eastern Cooperative Oncology Group (ECOG) status of ≤2.
  • Laboratory data:
  • Platelet count >75,000/mm3;
  • Hemoglobin >9.0 g/dL (may be maintained by transfusion);
  • Absolute neutrophil count >1500/mm3;
  • ALT/AST (Alanine aminotransferase/Aspartate aminotransferase)<2.5 times the upper limit of normal (ULN);
  • Total bilirubin <1.5 times ULN;
  • Creatinine <1.5 mg/dL.
  • Female patients of childbearing potential who are not surgically sterile or postmenopausal and male patients who are not surgically sterile must agree to use medically effective contraception during the treatment period and up to 60 days after the last AFM13 administration. The patient must agree to sign his or her consent on this particular inclusion criterion.
  • Ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
  • Be willing and able to comply with the study protocol for the duration of the study.

Who cannot join

  • Any significant diseases (other than HL (Hodgkin Lymphoma)) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the patient from participating in the study.
  • History or clinical evidence of central nervous system (CNS) HL.
  • Allogeneic SCT.
  • Major surgery within 4 weeks prior to study entry.
  • Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
  • Known history of another primary malignancy that has not been in remission for at least 5 years. Non-concurrent non-melanoma skin cancer and cervical carcinoma in situ or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia [CIN] or prostatic intraepithelial/intraductal neoplasia [PIN]) are allowed.
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  • Any active viral, bacterial, or systemic fungal infection within 4 weeks prior to study entry.
  • Known to be positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).
  • History of significant chronic or recurrent infections requiring treatment.
  • Receiving systemic steroid prednisone or equivalent during the 3 weeks immediately preceding enrollment.
  • Pregnant or breast-feeding.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Germany2 sites

  • University Hosptial Cologne

    Cologne, Köln, 50924 Köln

  • University Hospital Würzburg

    Würzburg, 97080

Other trials in Germany

United States1 site

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-2374

Other trials in United States

About this study

Official title: A Pharmacodynamically-Guided Dose Escalation Phase I Study to Assess the Safety of AFM13 (Recombinant Antibody Construct Against Human CD30 and CD16A) in Patients With Refractory and/or Relapsed Hodgkin Lymphoma

The aim of this study is to determine the safety, tolerability, pharmacokinetics and activity of single cycles of AFM13 in patients with CD30 positive refractory and/or relapsed Hodgkin lymphoma.

Read the detailed description

Study Objectives:

The overall objective of this study is to determine the safety, tolerability, pharmacokinetics and activity of single cycles of AFM13 in patients with CD30 positive refractory and/or relapsed Hodgkin lymphoma.

Objectives:

  1. To determine the safety and tolerability of increasing doses of single cycles of AFM13 monotherapy.
  2. To determine the OBD (Optimal Biological Dose) or MTD (Maximum Tolerated Dose) of AFM13; whichever is reached first.
  3. To define the pharmacokinetic profile of AFM13.
  4. To analyse immunological markers e.g. ADCC (Antibody dependent cell mediated cytotoxicity), NK (Natural killer) cell activity, complement activation and depletion, and cytokine release.
  5. To assess the immunogenicity of AFM13.
  6. To assess the activity of AFM13.
Being tested
AFM 13
Keywords
Phase I, Dose escalation, AFM 13, Natural killer cell
Medical subject headings
Hodgkin Disease

What participants receive

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

  • AFM 13Drug

    Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations.

Study groups in NCT01221571
Study groupRoleWhat they receive
AFM13ExperimentalIV (intravenous) infusion, dose escalation
Receives: Drug: AFM 13

What is being measured

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

  1. To determine the safety and tolerability of AFM13 monotherapy.

    Measure occurrence of adverse events and monitor laboratory safety parameters. Immunogenicity of AFM13.

    Measured: Length of Study

Secondary outcomes (5)

  1. To determine the OBD (Optimal Biological Dose) or MTD (Maximum Tolerated Dose) of AFM13

    Measured: Length of study

  2. To define the pharmacokinetic profile of AFM13.

    To test levels of AFM13 in blood samples and assess curve compared to dose of AFM13 administered.

    Measured: Length of study

  3. To analyse immunological markers of activity

    ADCC, NK cell, Complement and Cytokine levels in the serum will be measured at different time points to assess the level of activity resulting from administration of AFM13.

    Measured: Length of study

  4. To assess the immunogenicity of AFM13.

    Measured: length of study

  5. To assess the activity of AFM13

    To measure immunological activity useing biomarkers in the blood and to measure response of the disease in FDG-PET and CT scans.

    Measured: length of study

Timeline

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

  1. First posted15 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionMay 2013
  4. Study completionJun 2013

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221571
Sponsor's protocol ID
AFM13-101
Other IDs
2010-019232-13
Status last verified
Feb 2011
First submitted
5 Oct 2010
Last updated
26 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Rothe A, Sasse S, Topp MS, Eichenauer DA, Hummel H, Reiners KS, Dietlein M, Kuhnert G, Kessler J, Buerkle C, Ravic M, Knackmuss S, Marschner JP, Pogge von Strandmann E, Borchmann P, Engert A. A phase 1 study of the bispecific anti-CD30/CD16A antibody construct AFM13 in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2015 Jun 25;125(26):4024-31. doi: 10.1182/blood-2014-12-614636. Epub 2015 Apr 17.

    PubMed 25887777

  • Reiners KS, Kessler J, Sauer M, Rothe A, Hansen HP, Reusch U, Hucke C, Kohl U, Durkop H, Engert A, von Strandmann EP. Rescue of impaired NK cell activity in hodgkin lymphoma with bispecific antibodies in vitro and in patients. Mol Ther. 2013 Apr;21(4):895-903. doi: 10.1038/mt.2013.14. Epub 2013 Mar 5.

    PubMed 23459515

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AFM 13 in people with Hodgkin Lymphoma, run by Affimed GmbH at 3 sites in 2 countries.

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 17 inclusion and 11 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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

To determine the safety and tolerability of AFM13 monotherapy. (time frame: Length of Study). 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 NCT01221571, which also lists 2 linked publications.

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 26 Jun 2013.

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