Lymphoma, T-Cell, CutaneousPhase 2PARCTNCT03357224

PARCT: Trial of Atezolizumab in Relapsed/Refractory Cutaneous T Cell Lymphoma (CTCL)

A Phase 2 study testing Atezolizumab in people with Lymphoma, T-Cell, Cutaneous and Mycosis Fungoides/Sezary Syndrome, run by European Organisation for Research and Treatment of Cancer - EORTC at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapy For this study, we invite patients suffering from mycosis fungoides and Sézary syndrome who have progressed after initial therapy or have failed to respond… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides/Sezary Syndrome
What is being tested?: Atezolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesin 2 countries
Study dates: 24 Sep 2018to 18 Aug 2022
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients with diagnosis of CTCL (mycosis fungoides or Sézary-Syndrome) tumor stage IIB to IVB
Mandatory to ship tumor sample for evaluation of PD-L1 expression. A 4 mm formalin-fixed punch biopsy is recommended.
Inadequate response or secondary treatment failure to at least 1 prior systemic therapy for CTCL according to treatment guidelines (e.g. INF-2α or bexarotene).
Age ≥ 18 years old
WHO performance status 0-1
Adequate bone marrow and organ function prior to receiving the first dose of study treatment:

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Hemoglobin >10.0 g/dL (>100 g/L) or hematocrit >30% (>0.30 v/v);
White blood cell count >3.0 x 109/L (>3000/mm3);
Absolute neutrophil count of >1.5 x 109/L (>1500/mm3);
Platelet count >100 x 109/L (>100,000/mm3);
Estimated creatinine clearance >40 mL/min based on the Cockcroft Gault calculation or serum creatinine less than 1.5 times the upper limit of normal (ULN)
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) values less than 2 times the upper limit of normal (ULN)
Serum total bilirubin 1.5 ULN
Patients with suspicion of Gilbert disease who have serum bilirubin level 3 x ULN may be enrolled.
Clinically normal cardiac function based on 12 lead ECG without clinically relevant abnormalities and the institutional lower limit of normal for left ventricular ejection fraction as assessed either by multi-gated acquisition scan or cardiac ultrasound.
Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons.
Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 5 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomized partner
Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Who cannot join

Patients for whom only local therapy is indicated.
Received chemotherapy or targeted small molecule therapy within 4 weeks prior to registration.
Persistence of clinically relevant therapy-related toxicity from previous systemic treatment. Grade 1 or 2 adverse events (AEs) are acceptable.
Received a T cell depleting antibody (e.g. Campath) within 3 months prior to the first dose of atezolizumab.
Prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2.
History of other malignancy in the past 5 years with the exception of treated carcinoma in situ of the cervix and non-metastatic, non-melanoma skin cancer.

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Patients with known central nervous system (CNS) involvement with lymphoma.
History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins.
Known hypersensitivity to CHO cell products or any component of the atezolizumab formulation.
History of any of the following cardiovascular conditions within 6 months prior to the first dose of study treatment:
Unstable angina.
Clinically significant cardiac arrhythmias.
Myocardial infarction.
Have current or recent (past 6 months) history of severe, progressive, or uncontrolled renal, hepatic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
Severe infection within 4 weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Have active signs of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Any live, attenuated vaccine (e.g. FluMist®) is prohibited while the patient is receiving atezolizumab and for a period of 5 months after discontinuation of atezolizumab. Inactivated influenza vaccines are allowed only during flu season.
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.
Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
Rash must cover 10% of body surface area
Disease is well controlled at baseline and requires only low-potency topical corticosteroids
No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12months
Has a known history of HIV (test to be performed within 21 days of registration)
Has known active Hepatitis B or Hepatitis C. Note: patient will be eligible if
Negative hepatitis B surface antigen (HBsAg) test at screening
Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening . The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
Has immunodeficiency or on systemic steroid / immunosuppressive therapy within 7 days prior to the first dose of atezolizumab.
Note: systemic corticosteroids at doses ≤ 10 mg/day of prednisone or its equivalent is permitted
Current or previous history of non-infectious pneumonitis requiring steroids, or pulmonary fibrosis.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation.
Evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
Regarding hematopoietic stem cell transplantation:
Patients who had previously stem cell transplantation
Patients that are waiting for stem cell transplantation
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
All eligibility criteria must be adhered to, in case of deviation discussion with Headquarters and study coordinator is mandatory.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Spain1 site

Hospital Universitario 12 De Octubre
Madrid

Other trials in Spain

Switzerland1 site

UniversitaetsSpital Zurich - Division of Dermatology
Zurich

Other trials in Switzerland

About this study

Official title: Phase II Trial of Atezolizumab (Anti-PD-L1) in the Treatment of Stage IIb-IV Mycosis Fungoides/Sezary Syndrome Patients Relapsed/Refractory After a Previous Systemic Treatment

Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapy

For this study, we invite patients suffering from mycosis fungoides and Sézary syndrome who have progressed after initial therapy or have failed to respond to previous therapy.

Mycosis fungoides and Sézary syndrome are cancers in which lymphocytes* become malignant (cancerous) and affect the skin. In mycosis fungoides, the disease is generally limited to the skin, and people develop flat or raised areas on their skin where the lymphocytes have accumulated. Sometimes even larger aggregations of lymphocytes occur in the skin or lymph nodes, resulting in tumors. In Sézary syndrome, the skin is often reddened or itchy, and some abnormal lymphocytes circulate in the blood.

Lymphocytes are a type of immune cells that is made in the bone marrow and is found in the blood. Lymphocytes have a number of roles in the immune system, including the production of antibodies and other substances that fight infections and other diseases.

In standard practice, the disease will be treated with conventional chemotherapy that unfortunately has a limited lasting benefit. In this study, we want to see if a new treatment option can optimize and improve response and make benefit last as long as possible. This new treatment option is immunotherapy, using atezolizumab (Tecentriq).

Immunotherapy is a cancer treatment that uses antibodies made in the laboratory from a single type of immune system cell. These antibodies can identify substances on cancer cells or normal cells that may help cancer cell grow. The antibodies attach to the substances and kill the cancer cells, block their growth, or keep them from spreading. Atezolizumab blocks a protein called PD-L1 (programmed death-ligand 1) from binding to its receptor found on the surface of lymphocytes. It helps to restore the immune activity of the body against the cancer.

Atezolizumab is already used to treat adults with a cancer that affects the bladder and the urinary system, called urothelial carcinoma, and a cancer that affects the lungs, called non-small cell lung cancer.

In this trial, patients will receive atezolizumab for one year unless the tumor starts growing again or this is not considered suitable for them anymore or they wish to stop the treatment.

Conditions: Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides/Sezary Syndrome
Being tested: Atezolizumab
Medical subject headings: Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtezolizumabDrug
Also called Tecentriq
Patients will receive atezolizumab 1200 mg IV Q3w for 1 year.

Study groups in NCT03357224
Study group	Role	What they receive
Experimental: Atezolizumab	Experimental	The treatment will be given for a maximum of 1-year unless confirmed disease progression or unless other criteria for treatment discontinuation are met as specified in the protocol. Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Best overall response (CR+PR) rate (EORTC-ISCL-USCLC criteria)
Overall response rate is defined as the proportion of patients with global response score equal to CR or PR
Measured: Up to maximum 1 year starting from patient registration

Secondary outcomes (5)

Progression free survival (EORTC-International Society of Cutaneous Lymphoma (ISCL)-United States Cutaneous Lymphoma Consortium (USCLC) criteria)
From registration to progression
Measured: 6 months as of Last Patient In (LPI)
Overall survival (OS)
Registration till the date of death from any cause
Measured: 5 years as of LPI based on the median overall survival
Duration of response
From registration to progression
Measured: 6 months as of LPI
Time to response (CR/PR)
From registration to progression
Measured: 6 months as of LPI
Time to next systemic treatment
Time from the end of the current atezolizumab treatment until the time the next systemic treatment is recorded.
Measured: 8 months as of LPI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201818 Aug 2022

First posted29 Nov 2017
Study start24 Sep 2018
Primary completion11 Mar 2021
Study completion18 Aug 2022

Why it stopped: Following an urgent safety measure due to toxicity recruitment has been closed prematurely.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lymphoma, T-Cell, CutaneousStudies of the same condition, open and under way.
More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03357224
Sponsor's protocol ID: EORTC 1652-CLTF
Acronym: PARCT
Status last verified: Feb 2024
First submitted: 23 Nov 2017
Last updated: 22 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
Extracorporeal Photopheresis in Sezary Syndrome
Sezary Syndrome
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome

All Lymphoma, T-Cell, Cutaneous trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Atezolizumab (Anti-PD-L1) in the Treatment of Stage IIb-IV Mycosis Fungoides/Sezary Syndrome Patients Relapsed/Refractory After a Previous Systemic Treatment
ClinicalTrials.gov ID: NCT03357224
Acronym / sponsor ID: PARCT / EORTC 1652-CLTF
Conditions: Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides/Sezary Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Following an urgent safety measure due to toxicity recruitment has been closed prematurely.
Enrolment: 26 participants (actual)
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTCResearch network
Collaborators: Hoffmann-La Roche
Study start: 24 Sep 2018 (actual)
Primary completion: 11 Mar 2021 (actual)
Study completion: 18 Aug 2022 (actual)
First posted: 29 Nov 2017 (actual)
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.

Trial assessing atezolizumab (anti-PD-L1) as treatment option for patients with mycosis fungoides/sezary syndrome having progressed under or after previous therapy

For this study, we invite patients suffering from mycosis fungoides and Sézary syndrome who have progressed after initial therapy or have failed to respond to previous therapy.

Lymphocytes are a type of immune cells that is made in the bone marrow and is found in the blood. Lymphocytes have a number of roles in the immune system, including the production of antibodies and other substances that fight infections and other diseases.

In this trial, patients will receive atezolizumab for one year unless the tumor starts growing again or this is not considered suitable for them anymore or they wish to stop the treatment.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental: Atezolizumab	Experimental	Drug: AtezolizumabThe treatment will be given for a maximum of 1-year unless confirmed disease progression or unless other criteria for treatment discontinuation are met as specified in the protocol.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (27 listed)

Male or female patients with diagnosis of CTCL (mycosis fungoides or Sézary-Syndrome) tumor stage IIB to IVB
Mandatory to ship tumor sample for evaluation of PD-L1 expression. A 4 mm formalin-fixed punch biopsy is recommended.
Inadequate response or secondary treatment failure to at least 1 prior systemic therapy for CTCL according to treatment guidelines (e.g. INF-2α or bexarotene).
Age ≥ 18 years old
WHO performance status 0-1

Key exclusion criteria (38 listed)

Patients for whom only local therapy is indicated.
Received chemotherapy or targeted small molecule therapy within 4 weeks prior to registration.
Persistence of clinically relevant therapy-related toxicity from previous systemic treatment. Grade 1 or 2 adverse events (AEs) are acceptable.
Received a T cell depleting antibody (e.g. Campath) within 3 months prior to the first dose of atezolizumab.
Prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2.

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
AtezolizumabAlso: TecentriqPatients will receive atezolizumab 1200 mg IV Q3w for 1 year.	Drug	Experimental: Atezolizumab

Primary outcome

Best overall response (CR+PR) rate (EORTC-ISCL-USCLC criteria)
Time frame: Up to maximum 1 year starting from patient registration
Overall response rate is defined as the proportion of patients with global response score equal to CR or PR

5 secondary outcomes

Progression free survival (EORTC-International Society of Cutaneous Lymphoma (ISCL)-United States Cutaneous Lymphoma Consortium (USCLC) criteria)
Time frame: 6 months as of Last Patient In (LPI)
Overall survival (OS)
Time frame: 5 years as of LPI based on the median overall survival
Duration of response
Time frame: 6 months as of LPI
Time to response (CR/PR)
Time frame: 6 months as of LPI
Time to next systemic treatment
Time frame: 8 months as of LPI

Results and safety

The study was stopped early (reason given: Following an urgent safety measure due to toxicity recruitment has been closed prematurely.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.

Related trials for Lymphoma, T-Cell, Cutaneous

RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
Extracorporeal Photopheresis in Sezary Syndrome
Sezary Syndrome
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome

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.

Rudolf Stadler study chair

Johannes Wesling Klinikum Minden - Minden, Germany

Robert Knobler study chair

Medical University Vienna, General Hospital AKH - Vienna, Austria

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 27 inclusion and 38 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: stopped early, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain, Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Following an urgent safety measure due to toxicity recruitment has been closed prematurely.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best overall response (CR+PR) rate (EORTC-ISCL-USCLC criteria) (time frame: Up to maximum 1 year starting from patient registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03357224.

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 22 Feb 2024.