PARCT: Trial of Atezolizumab in Relapsed/Refractory Cutaneous T Cell Lymphoma (CTCL) (PARCT)
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|ClinicalTrials.gov Identifier: NCT03357224|
Recruitment Status : Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : July 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, T-Cell, Cutaneous Mycosis Fungoides/Sezary Syndrome||Drug: Atezolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||April 2025|
Experimental: Experimental: Atezolizumab
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.
Patients will receive atezolizumab 1200 mg IV Q3w for 1 year.
Other Name: Tecentriq
- 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
- 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) ]From registration to progression
- Overall survival (OS) [ Time Frame: 5 years as of LPI based on the median overall survival ]Registration till the date of death from any cause
- Duration of response [ Time Frame: 6 months as of LPI ]From registration to progression
- Time to response (CR/PR) [ Time Frame: 6 months as of LPI ]From registration to progression
- Time to next systemic treatment [ Time Frame: 8 months as of LPI ]Time from the end of the current atezolizumab treatment until the time the next systemic treatment is recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357224
|Contact: EORTC HQ||+32 2 774 firstname.lastname@example.org|
|UniversitaetsSpital Zurich - Division of Dermatology||Not yet recruiting|
|Principal Investigator: Emmanuella Guenova|
|Study Chair:||Rudolf Stadler||Johannes Wesling Klinikum Minden - Minden, Germany|
|Study Chair:||Robert Knobler||Medical University Vienna, General Hospital AKH - Vienna, Austria|