Clinical trial NCT01645293: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: CD30 Positive Cutaneous T Cell Lymphoma
CD30 Positive Transformed Mycosis Fungoides
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.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

Primary outcomes:
measure: Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.
measure: Definition of maximum tolerated dose (MTD) of engineered T cells #1138.
Secondary outcomes:
measure: Preliminary evidence of response to treatment
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
References: