EUCTR2006-002811-29-IT进行中（未招募）不适用
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 - PDX-008
ALLOS0 个研究点目标入组 100 人开始时间: 2006年12月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- 性别
- All
入选标准
- •1. Patient has histologically/cytologically confirmed PTCL, using the Revised European American Lymphoma REAL World Health Organization WHO disease classification a. T/Natural Killer 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 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 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. 3. Eastern Cooperative Oncology Group ECOG Performance Status 61603; 2. 4. At least 18 years of age. 5. Adequate hematological, hepatic, and renal function as defined by absolute neutrophil count ANC 1000/mL, platelet count 50,000/mL, total bilirubin 1.5 mg/dL, aspartate aminotransferase AST and alanine aminotransferase ALT 2.5 upper limit of normal ULN AST/ALT 5 ULN if documented hepatic involvement with lymphoma , creatinine 1.5 mg/dL or a calculated creatinine clearance 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 Number of subjects for this age range
排除标准
- •1. Patient has a. Precursor T/NK neoplasms, with the exception of blastic NK lymphoma b. T cell prolymphocytic leukemia T-PLL c. T cell large granular lymphocytic leukemia d. Mycosis fungoides, other than transformed mycosis fungoides e. Se zary 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 1 month. 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
相似试验
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 LymphomaEUCTR2006-002811-29-GBAllos Therapeutics, Inc.100
进行中（未招募）
不适用
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 LymphomaPhase 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 LymphomaEUCTR2006-002811-29-BEAllos Therapeutics, Inc.100
进行中（未招募）
不适用
A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Ageno medical, conditionhealthy, at risk volunteers will be recruited for a clinical trial to receive three vaccinations against meningococcal strain B and one vaccination against meningococcal strains A,C, W and Y.EUCTR2007-001563-29-DEovartis Vaccines and Diagnostics S.r.l.250
进行中（未招募）
不适用
A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age - NDPrevention Meningitis/Sepsi caused by Meningococcus type B or A, C, W-135, YMedDRA version: 9.1Level: SOCClassification code 10021881Term: Infections and infestationsEUCTR2007-001563-29-ITOVARTIS VACCINES AND DIAGNOSTICS S.R.L.250
进行中（未招募）
1 期
An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects with Relapsed or Refractory Small Cell Lung Cancer (SCLC)EUCTR2021-001530-19-HUKartos Therapeutics, Inc.56