Peripheral T-cell Lymphoma Clinical Trial
Official title:
A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients Previously Undiagnosed Peripheral T-cell Lymphoma Who Achieved an Objective Response After Initial Treatment With CHOP-based Chemotherapy
Verified date | November 2021 |
Source | Spectrum Pharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.
Status | Terminated |
Enrollment | 21 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification: - T/natural killer (NK)-cell leukemia/lymphoma - Adult T-cell lymphoma (TCL)/leukemia (human T-cell leukemia virus 1+) - Angioimmunoblastic TCL - Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score less than 2 at initial diagnosis and complete response (CR) after CHOP-based therapy - PTCL-unspecified - Enteropathy-type intestinal lymphoma - Hepatosplenic TCL - Subcutaneous panniculitis TCL - Transformed mycosis fungoides (tMF) - Extranodal T/NK-cell lymphoma nasal or nasal type - Primary cutaneous gamma-delta TCL - Primary cutaneous CD8+ aggressive epidermic cytotoxic TCL - Documented completion of at least 6 cycles of CHOP-based therapy: - CHOP 21 - CHOP 14 - CHOP + etoposide - Other CHOP variants: substitution allowed for 1 component with a drug of the same mechanism of action. Additional components, except alemtuzumab, are allowed. Rituximab may be added if not given within 3 cycles of randomization. - Patient has achieved CR or partial response (PR) per per investigator's assessment following completion of CHOP-based therapy and has had radiological assessment within 21 days prior to randomization. - Eastern Cooperative Oncology Group performance status less than or equal to 2. - Adequate blood, liver, and kidney function as defined by laboratory tests. - Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization and agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate. - Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for 90 days after the last administration of pralatrexate. - Has given written informed consent. Exclusion Criteria: - Patient has: - Precursor T/NK neoplasms - ALCL (ALK+) with IPI score less than 2 at initial diagnosis and CR after CHOP-based therapy - T cell prolymphocytic leukemia - T cell large granular lymphocytic leukemia - Mycosis fungoides, except tMF - Sézary syndrome - Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis - If there is a history of prior malignancies other than those below, must be disease free for at least 5 years. Patients with malignancies listed below less than 5 years before study entry may be enrolled if they have received treatment resulting in complete resolution of the cancer and have no clinical, radiologic, or laboratory evidence of active/recurrent disease. - non-melanoma skin cancer - carcinoma in situ of the cervix - localized prostate cancer - localized thyroid cancer - Receipt of prior chemotherapy (CT) or radiation therapy (RT) for PTCL, other than a single allowed CHOP regimen, except: - Patients with nasal NK lymphoma who received local RT less than 4 weeks prior to randomization. - Patients with tMF who received 1 systemic single-agent CT (except methotrexate) prior to transformation. - Prior exposure to pralatrexate. - Receipt of systemic corticosteroids within 3 weeks of study treatment, unless patient has been taking a continuous dose of 10 mg/day or less of oral prednisone or equivalent for at least 4 weeks or as part of a CHOP prednisone taper. - Planned use of any treatment for PTCL during the course of the study. - Patient has: - Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and receiving anti-retroviral therapy. - Hepatitis B (HBV)-positive serology and is receiving interferon therapy or has liver function test results outside the parameters of study inclusion criteria. Other antiviral therapies are permitted if at a stable dose for at least 4 weeks. - Hepatitis C (HCV) virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy. - Symptomatic central nervous system metastases or lesions requiring treatment. - Uncontrolled hypertension or congestive heart failure Class III/IV per the New York Heart Association's Heart Failure Guidelines - Active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness impairing the ability of the patient to receive protocol treatment. - Major surgery within 2 weeks prior to study entry, except for line placement or biopsy procedure. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Flinders Medical Center | Bedford Park | South Australia |
Australia | Monash Medical Centre | Clayton | Victoria |
Australia | Saint Vincent's Hospital Melbourne | Fitzroy | Victoria |
Australia | Frankston Hospital | Frankston | Victoria |
Australia | Royal Hobart Hospital | Hobart | Tasmania |
Australia | Cabrini Health | Malvern | Victoria |
Australia | Royal Perth Hospital | Perth | Western Australia |
Belgium | AZ Sint-Jan | Brugge | |
Belgium | Universitair Ziekenhuis Gent | Gent | |
Canada | Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec |
Canada | Sunnybrook Health Science Centre | Toronto | Ontario |
France | Hôpital Morvan | Brest | |
France | CHU Haut-Leveque | Pessac | |
Ireland | St James Hospital | Dublin 8 | |
Israel | Hadassah Ein-Kerem Medical Centre | Jerusalem | |
Israel | Shaare Zedek Medical Center | Jerusalem | |
Israel | Rabin Medical Center | Petach Tikva | |
Israel | Chaim Sheba Medical Center | Tel Hashomer | |
Italy | Az. Ospedaliera Universitaria S. Orsola Malpighi | Bologna | |
Italy | Spedali Civili di Brescia | Brescia | |
Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | Forli |
Italy | Ospedale S. Maria delle Croci | Ravenna | |
Italy | Università Cattolica del Sacro Cuore | Roma | |
Italy | Az. Ospedaliera Università Senese | Siena | |
New Zealand | Auckland City Hospital / Auckland University | Auckland | |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | North Shore Hospital | Milford | |
New Zealand | Middlemore Hospital | Otahuhu | Auckland |
Poland | Dept of Hematology and Transplantology | Gdansk | |
Poland | Malopolskie Centrum Medyczne | Kraków | |
Poland | Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie | Warszawa | Mazowieckie |
Puerto Rico | Auxilio Mutuo Cancer Center | San Juan | |
Spain | Complejo Hospitalario Universitario A Coruña- Hospital A Coruña | A Coruña | |
Spain | Hospital Clínic i Provincial de Barcelona | Barcelona | |
Spain | Hospital General Vall d'Hebron | Barcelona | |
Spain | Hospital de Madrid Norte-Sanchinarro | Madrid | |
Spain | Hospital Universitario Puerta de Hierro Majadahonda | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | Clinica Universidad de Navarra | Pamplona | Navarra |
Spain | Complejo Hospitalario de Navarra, Servicio de Hematologia | Pamplona | Navarra |
United Kingdom | Antrim Area Hospital | Antrim | Northern Ireland |
United Kingdom | Belfast City Hospital | Belfast | |
United Kingdom | Velindre Hospital | Cardiff | |
United Kingdom | NHS Greater Glasgow and Clyde Western Infirmary | Glasgow | Scotland |
United Kingdom | Royal Liverpool University Hospital | Liverpool | |
United Kingdom | Mount Vernon Cancer Centre | Middlesex | |
United Kingdom | Derriford Hospital | Plymouth | England |
United Kingdom | Poole Hospital NHS Foundation Trust, Poole General Hospital | Poole | Dorset |
United Kingdom | Royal Cornwall Hospital | Truro | Cornwall |
United Kingdom | UHCW (University Hospital Coventry and Warwickshire) | Warwick | |
United Kingdom | Sandwell & West Birmingham Hospitals NHS Trust | West Bromwich | England |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | New York Presbyterian Hospital | New York | New York |
United States | Detroit Clinical Research Center, PC | Novi | Michigan |
Lead Sponsor | Collaborator |
---|---|
Spectrum Pharmaceuticals, Inc |
United States, Australia, Belgium, Canada, France, Ireland, Israel, Italy, New Zealand, Poland, Puerto Rico, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival (PFS) | PFS was defined as the time in days from randomization to the date of objective documentation of progressive disease (PD) or death, regardless of cause (date of PD or death - date of randomization + 1). PFS was to be assessed according to the International Workshop Criteria (IWC) without including positron emission tomography (PET). PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Participants who were alive without a disease response assessment of PD was to be censored at their last disease assessment date or the date of randomization, whichever was later. Date of progression was not to be imputed for participants with missing tumor assessments before an assessment of PD. Participants who withdraw from treatment prior to PD were to be followed for disease status whenever possible. Participants who have no response assessments after baseline were to be censored at randomization. | From randomization to the date of progression of disease or death due to any cause (up to 76 months) | |
Primary | Overall Survival (OS) | Overall survival was defined as the time in days from randomization to the date of death, regardless of cause (date of death - date of randomization + 1). | From randomization until death (up to 76 months) | |
Secondary | Objective Response Rate | Objective response rate was defined as percentage of participants with an objective response of complete response (CR) or partial response (PR), relative to disease status at the time of study entry. The percentage was to be calculated by dividing number of participants within each category of response by the number of participants with measurable disease at baseline. Objective response was assessed according to the IWC without including PET. CR was defined as complete disappearance all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR was defined as regression of measurable disease and no new sites. | Up to 2 years | |
Secondary | Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. AE included both serious and non- SAEs. An AE of "Hematology and Chemistry" was collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening and Grade 4 refers to life-threatening consequences. | From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years) |
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