CD30 Positive Cutaneous T Cell LymphomaPhase 1TECLANCT01645293
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
A Phase 1 study testing Genetically modified T cells # 1138 in people with CD30 Positive Cutaneous T Cell Lymphoma and CD30 Positive Transformed Mycosis Fungoides, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CD30 Positive Cutaneous T Cell Lymphoma, CD30 Positive Transformed Mycosis Fungoides
- What is being tested?
- Genetically modified T cells # 1138
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.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),
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Michael Hoffmann, MD contact
Germany1 site
University Hospital of Cologne
Cologne, 50937
Michael Hoffmann, MD, michael.hoffmann@uk-koeln.de
About this study
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.
- Being tested
- Genetically modified T cells # 1138
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetically modified T cells # 1138Genetic
| Study group | Role | What they receive |
|---|---|---|
| Genetically modified T cells #1138 | Experimental | Not described Receives: Genetic: Genetically modified T cells # 1138 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.
Definition of maximum tolerated dose (MTD) of engineered T cells #1138.
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD30 Positive Cutaneous T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Dr. rer. nat Cornelia Mauch, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645293
- Sponsor's protocol ID
- Uni-Koeln-1065
- Acronym
- TECLA
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01645293
- Acronym / sponsor ID
- TECLA / Uni-Koeln-1065
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genetically modified T cells #1138 | Experimental | Genetic: Genetically modified T cells # 1138 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetically modified T cells # 1138 | Genetic | Genetically modified T cells #1138 |
Primary outcome
Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.
Definition of maximum tolerated dose (MTD) of engineered T cells #1138.
1 secondary outcome
Preliminary evidence of response to treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hoffmann, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Genetically modified T cells # 1138 in people with CD30 Positive Cutaneous T Cell Lymphoma and CD30 Positive Transformed Mycosis Fungoides, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Hoffmann, MD (michael.hoffmann@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients experiencing dose limiting toxicities of engineered T cells #1138.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2012.