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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
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CD30 Positive Cutaneous T Cell Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.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

First Posted
July 11, 2012
Last Updated
July 17, 2012
Sponsor
University of Cologne
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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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