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
Phase 1
18 Years
70 Years
18 Years
70 Years
Not Enrolling
Both
CD30 Positive Cutaneous T Cell Lymphoma, CD30 Positive Transformed Mycosis Fungoides
Both
CD30 Positive Cutaneous T Cell Lymphoma, CD30 Positive Transformed Mycosis Fungoides
Trial Information
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
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understanding that the consent may be withdrawn by the patient at any time without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
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.
Safety Issue:
Yes
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
Uni-Koeln-1065
NCT ID:
NCT01645293
Start Date:
Completion Date:
Related Keywords:
- CD30 Positive Cutaneous T Cell Lymphoma
- CD30 Positive Transformed Mycosis Fungoides
- Lymphoma
- Mycoses
- Mycosis Fungoides
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, Primary Cutaneous Anaplastic Large Cell
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