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)
Primary Purpose
CD30 Positive Cutaneous T Cell Lymphoma, CD30 Positive Transformed Mycosis Fungoides
Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Genetically modified T cells # 1138
Sponsored by
About this trial
This is an interventional treatment trial for CD30 Positive Cutaneous T Cell Lymphoma
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written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.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
Sites / Locations
- University Hospital of Cologne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Genetically modified T cells #1138
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.
Definition of maximum tolerated dose (MTD) of engineered T cells #1138.
Secondary Outcome Measures
Preliminary evidence of response to treatment
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01645293
Brief 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
Acronym
TECLA
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
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD30 Positive Cutaneous T Cell Lymphoma, CD30 Positive Transformed Mycosis Fungoides
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Genetically modified T cells #1138
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
Genetically modified T cells # 1138
Primary Outcome Measure Information:
Title
Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.
Title
Definition of maximum tolerated dose (MTD) of engineered T cells #1138.
Secondary Outcome Measure Information:
Title
Preliminary evidence of response to treatment
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Hoffmann, MD
Email
michael.hoffmann@uk-koeln.de
Facility Information:
Facility Name
University Hospital of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Hoffmann, MD
Email
michael.hoffmann@uk-koeln.de
12. IPD Sharing Statement
Learn more about this trial
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
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