Multicentre Phase I Trial of Engineered T Cells for Patients With Relapsed or Refractory Primary Cutaneous CD30+ Large T Cell Lymphoma or Transformed CD30+ Mycosis Fungoides (TECLA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Cologne.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Dr. rer. nat Cornelia Mauch, University of Cologne
ClinicalTrials.gov Identifier:
NCT01645293
First received: July 11, 2012
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

Patients with cutaneous CD30 positive lymphoma will receive systemical and topical treatment with their own genetically modified T cells. Treatment evaluation consists of assessment of safety and preliminary evidence of response.


Condition Intervention Phase
CD30 Positive Cutaneous T Cell Lymphoma
CD30 Positive Transformed Mycosis Fungoides
Genetic: Genetically modified T cells # 1138
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentre Phase I Trial of Engineered T Cells for Patients With Relapsed or Refractory Primary Cutaneous CD30+ Large T Cell Lymphoma or Transformed CD30+ Mycosis Fungoides

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Rate of patients experiencing dose limiting toxicities of engineered T cells #1138. [ Designated as safety issue: Yes ]
  • Definition of maximum tolerated dose (MTD) of engineered T cells #1138. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preliminary evidence of response to treatment [ Designated as safety issue: No ]
    • Complete Response (CR): Disappearance of treated lesion.
    • Partial Response (PR): At least 30% decrease in the sum of two diameters compared to the initiatal diameters of the treated lesion.
    • Progressive Disease (PD): At least 20% increase in the sum of two diameters of treated lesions.
    • Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of two diameters while on study.


Estimated Enrollment: 15
Arms Assigned Interventions
Experimental: Genetically modified T cells #1138 Genetic: Genetically modified T cells # 1138

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.
  • Male or female > 18 years of age to 70 years of age
  • Diagnosis of primary cutaneous CD30+ large T cell lymphoma OR
  • Diagnosis of transformed CD30+ mycosis fungoides, i.e.,
  • Histological confirmation of diagnosis.
  • multiple (> 5) cutaneous tumor lesions (TNM EORTC 2007 T3, N1, clinical stage <IIb),
  • Measurable disease according to RECIST criteria
  • Refractory or relapsed disease after at least one line of treatment, e.g. PUVA (Psoralen plus UVA), PUVA + Interferon, oral Bexarotene, low dose MTX)
  • ECOG performance status 0-3
  • Life expectancy > 12 months
  • Female patients with childbearing potential must have a negative serum pregnancy test within two weeks of first dose of study drug. Male and female patients must agree to use an effective oral contraceptive method while on study treatment, if appropriate, and for a minimum of twelve months following study therapy

Exclusion Criteria:

  • Previously untreated patients
  • Presence of any organ or brain involvement as determined during tumor staging by contrast computed tomography [CT] or magnetic resonance imaging [MRI] scan
  • Known hereditary blood coagulation disorders/DIC
  • Prior allogeneic hematopoietic stem-cell or organ transplantation
  • Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency > NHYA-II
  • known active infection including HIV, Hepatitis B or C, VZV, or CMV
  • Insufficient bone marrow reserve (Leucocytes <3.500/μl; Thrombocytes <100.000/μl)
  • Creatinine-Clearance < 50 ml/min or Crea > 1.8 mg/dl
  • Bilirubin > 2 mg/dl; ASAT, ALAT > 2.5xN
  • Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
  • Known pulmonary dysfunction
  • Requirement of chronic immune suppression
  • Treatment with corticosteroids for concomitant or intercurrent disease
  • Having participated in another clinical trial or any IND in the preceding 4 weeks
  • Anti-cancer chemotherapy in the preceding 4 weeks
  • Known drug abuse/alcohol abuse
  • Known allergic/hypersensitivity reaction to any of the components of the treatment
  • Known serious uncontrolled infections
  • Known active secondary malignancy or other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the skin or cervix
  • Medical or psychological condition or inadequate knowledge of german language which in the opinion of the investigator would not permit the patient to complete the study or meaningfully sign informed consent
  • Legal incapacity or limited legal capacity
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645293

Contacts
Contact: Michael Hoffmann, MD michael.hoffmann@uk-koeln.de

Locations
Germany
University Hospital of Cologne Not yet recruiting
Cologne, Germany, 50937
Contact: Michael Hoffmann, MD       michael.hoffmann@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Dr. rer. nat Cornelia Mauch, Consultant dermatologist, CIO tumor centre, University of Cologne
ClinicalTrials.gov Identifier: NCT01645293     History of Changes
Other Study ID Numbers: Uni-Koeln-1065
Study First Received: July 11, 2012
Last Updated: July 17, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Lymphoma
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, Primary Cutaneous Anaplastic Large Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on July 13, 2014