Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01221571
Other study ID # AFM13-101
Secondary ID 2010-019232-13
Status Completed
Phase Phase 1
First received October 5, 2010
Last updated June 25, 2013
Start date October 2010
Est. completion date June 2013

Study information

Verified date February 2011
Source Affimed GmbH
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Paul-Ehrlich-Institut
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date June 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Histological diagnosis of relapsed or refractory Hodgkin lymphoma expressing the CD30 antigen.

2. Age =18 years.

3. Both genders.

4. 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.

5. Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry.

6. Patients who received ASCT should have fully recovered prior to study entry.

7. Eastern Cooperative Oncology Group (ECOG) status of =2.

8. Laboratory data:

1. Platelet count >75,000/mm3;

2. Hemoglobin >9.0 g/dL (may be maintained by transfusion);

3. Absolute neutrophil count >1500/mm3;

4. ALT/AST (Alanine aminotransferase/Aspartate aminotransferase)<2.5 times the upper limit of normal (ULN);

5. Total bilirubin <1.5 times ULN;

6. Creatinine <1.5 mg/dL.

9. 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.

10. 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.

11. Be willing and able to comply with the study protocol for the duration of the study.

Exclusion Criteria:

1. 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.

2. History or clinical evidence of central nervous system (CNS) HL.

3. Allogeneic SCT.

4. Major surgery within 4 weeks prior to study entry.

5. Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.

6. 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.

7. Any active viral, bacterial, or systemic fungal infection within 4 weeks prior to study entry.

8. Known to be positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).

9. History of significant chronic or recurrent infections requiring treatment.

10. Receiving systemic steroid prednisone or equivalent during the 3 weeks immediately preceding enrollment.

11. Pregnant or breast-feeding.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AFM 13
Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations.

Locations

Country Name City State
Germany University Hosptial Cologne Koln Köln
Germany University Hospital Würzburg Würzburg
United States The University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Affimed GmbH

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the safety and tolerability of AFM13 monotherapy. Measure occurrence of adverse events and monitor laboratory safety parameters. Immunogenicity of AFM13. Length of Study Yes
Secondary To determine the OBD (Optimal Biological Dose) or MTD (Maximum Tolerated Dose) of AFM13 Length of study Yes
Secondary To define the pharmacokinetic profile of AFM13. To test levels of AFM13 in blood samples and assess curve compared to dose of AFM13 administered. Length of study No
Secondary 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. Length of study No
Secondary To assess the immunogenicity of AFM13. length of study Yes
Secondary 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. length of study No
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05019976 - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma N/A
Active, not recruiting NCT03617666 - Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study Phase 2
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Recruiting NCT02507479 - Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies Phase 2
Active, not recruiting NCT02191930 - Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma Phase 2
Completed NCT01943682 - Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma Phase 1
Completed NCT01393106 - Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma Phase 2
Terminated NCT00992030 - R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma Phase 3
Terminated NCT00722865 - Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma Phase 2
Unknown status NCT00598624 - Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) Phase 2
Completed NCT03242902 - To Decrease Fatigue With Light Therapy Phase 3
Active, not recruiting NCT05205512 - Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial N/A
Recruiting NCT03681561 - Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma Phase 1/Phase 2
Recruiting NCT03250962 - SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma Phase 2
Recruiting NCT04510610 - Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma Phase 2/Phase 3
Completed NCT06295211 - Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
Active, not recruiting NCT02256137 - A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
Completed NCT02432235 - Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma Phase 1