Study of Pralatrexate Versus Observation Following CHOP-based Chemotherapy in Previously Undiagnosed Peripheral T-cell Lymphoma Patients
Verified June 2014 by Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
First received: August 18, 2011
Last updated: June 12, 2014
Last verified: June 2014
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.
Peripheral T-cell Lymphoma
Drug: Pralatrexate Injection
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Progression-free Survival (PFS) [ 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 ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: Collected approximately every 6 months after documented PD through 7 years post-randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective Response to Pralatrexate versus Observation [ 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
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.
Drug: 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.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420679
Spectrum Pharmaceuticals, Inc
||Pankaj Sharma, MD
||Spectrum Pharmaceuticals, Inc
No publications provided
||Spectrum Pharmaceuticals, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 18, 2011
||June 12, 2014
||United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: Ethics Committee
Israel: Ethics Commission
New Zealand: Medsafe
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Keywords provided by Spectrum Pharmaceuticals, Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Immune System Diseases
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action