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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01420679




Trial ID
NCT01420679
Ethics application status
Date submitted
18/08/2011
Date registered
19/08/2011
Date last updated
30/04/2018

Titles & IDs
Public title
Study of Pralatrexate Versus Observation Following CHOP-based Chemotherapy in Previously Undiagnosed Peripheral T-cell Lymphoma Patients
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
Secondary ID [1] 0 0
2010-022230-81
Secondary ID [2] 0 0
PDX-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral T-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pralatrexate Injection

Experimental: Pralatrexate - Patients randomized to the Pralatrexate Arm will receive pralatrexate injection and Vitamins B12 and Folic Acid until a criterion for pralatrexate injection treatment discontinuation is met.

No Intervention: Observation - Patients randomized to the Observation Arm will receive Vitamins B12 and Folic Acid and remain under observation until a criterion for observation discontinuation is met.


Treatment: Drugs: Pralatrexate Injection
Intravenous (IV) push administration over 30 seconds to 5 minutes via a patent IV line containing normal saline (0.9% sodium chloride).
Initial dose: 30 mg/m2
Administered weekly for 3 weeks of a 4-week cycle until criteria for discontinuation per the protocol are met.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Collected approximately every 6 months after documented PD through 7 years post-randomization
Secondary outcome [1] 0 0
Objective Response to Pralatrexate versus Observation
Timepoint [1] 0 0
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

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Saint Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Frankston Hospital - Frankston
Recruitment hospital [7] 0 0
Cabrini Health - Malvern
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
7001 - Hobart
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3109 - Fitzroy
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Belgium
State/province [3] 0 0
Brugge
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
France
State/province [7] 0 0
Brest
Country [8] 0 0
France
State/province [8] 0 0
Pessac
Country [9] 0 0
Ireland
State/province [9] 0 0
Dublin 8
Country [10] 0 0
Israel
State/province [10] 0 0
Jerusalem
Country [11] 0 0
Israel
State/province [11] 0 0
Petach Tikva
Country [12] 0 0
Israel
State/province [12] 0 0
Tel Hashomer
Country [13] 0 0
Italy
State/province [13] 0 0
Forli
Country [14] 0 0
Italy
State/province [14] 0 0
Bologna
Country [15] 0 0
Italy
State/province [15] 0 0
Brescia
Country [16] 0 0
Italy
State/province [16] 0 0
Ravenna
Country [17] 0 0
Italy
State/province [17] 0 0
Roma
Country [18] 0 0
Italy
State/province [18] 0 0
Siena
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland
Country [20] 0 0
New Zealand
State/province [20] 0 0
Christchurch
Country [21] 0 0
New Zealand
State/province [21] 0 0
Milford
Country [22] 0 0
Poland
State/province [22] 0 0
Mazowieckie
Country [23] 0 0
Poland
State/province [23] 0 0
Gdansk
Country [24] 0 0
Poland
State/province [24] 0 0
Kraków
Country [25] 0 0
Puerto Rico
State/province [25] 0 0
San Juan
Country [26] 0 0
Spain
State/province [26] 0 0
Navarra
Country [27] 0 0
Spain
State/province [27] 0 0
A Coruña
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Majadahonda, Madrid
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Cornwall
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Dorset
Country [33] 0 0
United Kingdom
State/province [33] 0 0
England
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Northern Ireland
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Scotland
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Belfast
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Cardiff
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Liverpool
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Middlesex
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Warwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Spectrum Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT01420679
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pankaj Sharma, MD
Address 0 0
Spectrum Pharmaceuticals, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries