Back to results

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

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written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.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

NCT ID

NCT01645293

First Posted

July 11, 2012

Last Updated

July 17, 2012

Sponsor

University of Cologne

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

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

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

We'll reach out to this number within 24 hrs