EUCTR2006-002811-29-GB进行中（未招募）1 期
A Multi-center Phase 2 Open-label Study of (RS)-10-Propargyl-10-Deazaaminopterin (pralatrexate) with Vitamin B12 and Folic Acid Supplementation in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patient has histologically/cytologically confirmed PTCL, using the Revised European
- •American Lymphoma (REAL) WHO disease classification:
- •a. T/NK-cell leukemia/lymphoma
- •b. Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
- •c. Angioimmunoblastic T-cell lymphoma
- •d. Blastic NK lymphoma (with skin, lymph node, or visceral involvement)
- •e. Anaplastic large cell lymphoma, primary systemic type
- •Allos Therapeutics, Inc.
- •Protocol PDX-008 Page 37
- •f. PTCL – unspecified
- •g. T/NK-cell lymphoma – nasal
- •h. Enteropathy-type intestinal lymphoma
- •i. Hepatosplenic T-cell lymphoma
- •j. Extranodal peripheral T/NK-cell lymphoma – unspecified
- •k. Subcutaneous panniculitis T-cell lymphoma
- •l. Transformed mycosis fungoides
- •2. Patient has documented progression of disease after at least 1 prior treatment.
- •Patients may not have received experimental drugs or biologics as their only prior
- •therapy. Patient must have clear disease progression after the last treatment received.
- •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 a FDA-approved monoclonal antibody therapy may be enrolled
- •regardless of the time frame of the therapy if they have progression of disease.
- •3. ECOG Performance Status = 2.
- •4. At least 18 years of age.
- •5. Adequate hematological, hepatic, and renal function as defined by: ANC = 1000/µL,
- •platelet count = 100,000/µL (at both screening and within 3 days prior to dosing on
- •cycle 1, day 1), total bilirubin = 1.5 mg/dL, aspartate aminotransferase (AST) and
- •ALT = 2.5 × ULN, (AST/ALT < 5 × ULN if documented hepatic involvement with
- •lymphoma), creatinine = 1.5 mg/dL (if the patient’s creatinine is > 1.5 mg/dL, then
- •the calculated creatinine clearance must be = 50 mL/min).
- •6. 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 (> 12 months since last menses) or are surgically
- •sterilized do not require this test.
- •7. 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.
- •8. Patient has given written informed consent (IC).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Num
排除标准
- •1. Patient has:
- •a. Precursor T/NK neoplasms, with the exception of blastic NK lymphoma
- •c. T-cell large granular lymphocytic leukemia
- •d. Mycosis fungoides, other than transformed mycosis fungoides
- •e. Sézary syndrome
- •f. Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and
- •lymphomatoid papulosis
- •2. 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 = 5 years.
- •3. Congestive heart failure Class III/IV according to the New York Heart Association’s
- •Heart Failure Guidelines.
- •4. Uncontrolled hypertension.
- •5. Human immunodeficiency virus (HIV)-positive diagnosis and is receiving
- •combination anti-retroviral therapy.
- •6. Patient has, or history of, brain metastases or central nervous system (CNS) disease.
- •7. Patient has undergone an allogeneic stem cell transplant.
- •8. Patient has relapsed less than 75 days from time of an autologous stem cell transplant.
- •9. 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.
- •10. Patient has had major surgery within 2 weeks of study entry.
- •11. 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.
- •12. 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
- •13. Use of any investigational drugs, biologics, or devices within 4 weeks prior to study
- •treatment or planned use during the course of the study.
- •14. Previous exposure to pralatrexate.
研究者
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