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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Peripheral T-cell Lymphoma

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Trial Information

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


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

- S├ęzary 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Show-Li Sun, MD

Investigator Role:

Study Director

Investigator Affiliation:

Spectrum Pharmaceuticals, Inc

Authority:

United States: Food and Drug Administration

Study ID:

PDX-017

NCT ID:

NCT01420679

Start Date:

August 2011

Completion Date:

December 2017

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Lymphoproliferative Disorders
  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • T-cell Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
New York Presbyterian Hospital New York, New York  10021
Georgia Health Sciences University Augusta, Georgia  30912
Detroit Clinical Research Center, PC Novi, Michigan  48377