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

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Medical Conditions
  • Peripheral T-cell Lymphoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Stopped
Trial source and source ID number
NCT01420679

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
Rheumatology Department, Poole Hospital NHS Trust
Poole
BH15 2JB
Belfast
BT9 7AB
Truro
TR1 3LJ
Liverpool
Merseyside
L7 8XP
City Hospital - Birmingham
West Bromwich
England
B71 4HJ
Glasgow Renal and Transplant Unit
Glasgow
G11 6NT
Mount Vernon Cancer Centre
HA6 2RN
Derriford Hospital
Plymouth
England
PL68DH
Antrim Area Hospital
Antrim
Northern Ireland
BT41 2RL
UHCW (University Hospital Coventry and Warwickshire)
CA34 5BW
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Canada, France, Ireland, Israel, Italy, New Zealand, Poland, Puerto Rico, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

18 Aug 2011

Date updated in source

11 Aug 2014