Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
NCT ID: NCT00364923
Last Updated: 2019-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
115 participants
INTERVENTIONAL
2006-08-31
2009-02-24
Brief Summary
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• Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)
Secondary
* Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL
* Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation
Detailed Description
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Pralatrexate will be given over 3-5 minutes intravenously (IV), which means through a vein. If pralatrexate is tolerated well, the patient will receive IV injections of pralatrexate every week for 6 weeks, followed by 1 week without receiving pralatrexate. These 7 week cycles will be repeated depending on response and tolerability.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Pralatrexate Injection
Pralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. T/Natural Killer (T/NK) cell leukemia/lymphoma
2. Adult T-cell lymphoma/leukemia (human T-cell leukemia virus \[HTLV\] 1+)
3. Angioimmunoblastic T cell lymphoma
4. Blastic Natural Killer (NK) lymphoma (with skin, lymph node, or visceral involvement)
5. Anaplastic large cell lymphoma, primary systemic type
6. PTCL - unspecified
7. T/NK-cell lymphoma - nasal
8. Enteropathy-type intestinal lymphoma
9. Hepatosplenic T cell lymphoma
10. Extranodal peripheral T/NK-cell lymphoma - unspecified
11. Subcutaneous panniculitis T-cell lymphoma
12. Transformed mycosis fungoides
* Documented progression of disease after at least 1 prior treatment. Patients may not have received experimental therapy as their only prior therapy. Patient has at least 1 biopsy from initial diagnosis or in the relapsed setting to confirm the diagnosis of PTCL. Patient has recovered from the toxic effects of prior therapy. Patients treated with monoclonal antibody therapy may be enrolled regardless of the time frame of the therapy if they have progression of disease.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* ≥ 18 years of age.
* Adequate hematological, hepatic, and renal function.
* Women of childbearing potential must agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 30 days after the last administration of pralatrexate and must have a negative serum pregnancy test within 14 days prior to the first day of study treatment. Patients who are postmenopausal for at least 1 year or are surgically sterilized do not require this test.
* Men who are not surgically sterile must agree to practice a medically acceptable contraceptive regimen from study treatment initiation until at least 90 days after the last administration of pralatrexate.
* Patient has given written informed consent.
Exclusion Criteria
1. Precursor T/NK neoplasms, with the exception of blastic NK lymphoma
2. T cell prolymphocytic leukemia (T-PLL)
3. T cell large granular lymphocytic leukemia
4. Mycosis fungoides, other than transformed mycosis fungoides
5. Sézary syndrome
6. Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphomatoid papulosis
* Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease free for greater than or equal to 5 years.
* Congestive heart failure Class III/IV according to the New York Heart Association's Heart Failure Guidelines.
* Uncontrolled hypertension.
* Human immunodeficiency virus (HIV)-positive diagnosis and is receiving combination anti-retroviral therapy.
* Patient has, or history of, brain metastases or central nervous system (CNS) disease.
* Patient has undergone an allogeneic stem cell transplant.
* Patient has relapsed less than 75 days from time of an autologous stem cell transplant.
* Active uncontrolled infection, underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to receive protocol treatment.
* Major surgery within 2 weeks of study entry.
* Receipt of any conventional chemotherapy or radiation therapy (RT) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the course of the study.
* Receipt of corticosteroids within 7 days of study treatment, unless patient has been taking a continuous dose of no more than 10 mg/day of prednisone for at least 1 month.
* Use of any investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the course of the study.
* Previous exposure to pralatrexate.
18 Years
ALL
No
Sponsors
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Acrotech Biopharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Owen O'Connor, MD, PhD
Role: STUDY_CHAIR
Columbia University
Locations
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City of Hope National Medical Center
Duarte, California, United States
University of California at Los Angeles
Los Angeles, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Cliniques Universitaire Saint-Luc
Brussels, , Belgium
Cliniques Universitaires UCL
Yvoir, , Belgium
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CHU Henri Mondor
Créteil, , France
CHU DIJON - Hôpital d'enfant
Dijon, , France
CHU Nice - Hôpital de l'Archet 1
Nice, , France
CHU Nantes - Hôtel Dieu
Paris, , France
CHU Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Robert Debré
Reims, , France
Ospedale Sant'Orsola - Policlinico Sant'Orsola
Bologna, , Italy
St. Georges Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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Other Identifiers
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2006-002811-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PDX-008
Identifier Type: -
Identifier Source: org_study_id