Study of Pralatrexate Versus Observation Following CHOP-based Chemotherapy in Previously Undiagnosed Peripheral T-cell Lymphoma Patients | Stopped
Study of Pralatrexate Versus Observation Following CHOP-based Chemotherapy in Previously Undiagnosed Peripheral T-cell Lymphoma Patients

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Peripheral T-cell Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Stopped
Recruitment Status
NCT01420679
Primary Trial ID Number
Summary
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Pralatrexate Injection

Study Arm Groups : Pralatrexate

Intervention Type
See Interventions above
Primary Outcome Measures
  • Progression-free Survival (PFS); Assessed at 8 weeks (+/-1 wk) then every 12 weeks (+/-1 wk) through 3 years, then every 24 weeks (+/-4 wks) until progression of disease (PD) or up to 7 years post-randomization; Overall Survival (OS); Collected approximately every 6 months after documented PD through 7 years post-randomization
Secondary Outcome Measures
  • Objective Response to Pralatrexate versus Observation; Assessed at 8 weeks (+/-1 wk) then every 12 weeks (+/-1 wk) through 3 years, then every 24 weeks (+/-4 wks) until progression of disease (PD) or up to 7 years post-randomization
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Royal Liverpool University Hospital
Liverpool
England
L7 8XP
Research Site
Truro
Cornwall
TR1 3LJ
Belfast City Hospital
Belfast
BT9 7AB
GSK Investigational Site
Glasgow
G11 6NT
Mount Vernon Hospital
Middlesex
HA6 2RN
Novartis Investigative Site
Cardiff
CF14 2TL
Poole
Dorset
BH15 2JB
Sandwell Hospital
West Bromwich
B71 4HJ
UHCW (University Hospital Coventry and Warwickshire)
Warwick
CA34 5BW
Derriford Hospital
Devon
England
PL68DH
Antrim Area Hospital
County Antrim
Northern Ireland
BT41 2RL
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Australia, Belgium, Canada, France, Ireland, Israel, Italy, New Zealand, Poland, Spain, United Kingdom
Scientific Title
A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients With Previously Undiagnosed Peripheral T-cell Lymphoma Who Have Achieved an Objective Response Following Initial Treatment With CHOP-based Chemotherapy
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
PDX-017
Sponsor(s)
Spectrum Pharmaceuticals, Inc
Key Dates

Recruitment Start Date

Aug 2011

Recruitment End Date

Dec 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

18 Aug 2011

Last Updated

11 Aug 2014