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

NCT ID: NCT01645293

Last Updated: 2012-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Conditions

CD30 Positive Cutaneous T Cell Lymphoma; CD30 Positive Transformed Mycosis Fungoides

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genetically modified T cells #1138

Group Type: EXPERIMENTAL

Genetically modified T cells # 1138

Intervention Type: GENETIC

Interventions

Genetically modified T cells # 1138

Intervention Type: GENETIC

Eligibility 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written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Dr. rer. nat Cornelia Mauch

Consultant dermatologist, CIO tumor centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Cologne

Cologne, , Germany

Countries

Germany

Central Contacts

Michael Hoffmann, MD

Role: CONTACT

Email: michael.hoffmann@uk-koeln.de

Facility Contacts

Michael Hoffmann, MD

Role: primary

Other Identifiers

Uni-Koeln-1065

Identifier Type: -

Identifier Source: org_study_id