NCT00481871已完成1 期
A Phase 1/2a Open-label Study of Pralatrexate and Gemcitabine With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Lymphoproliferative Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 15
- 主要终点
- Objective Responses Assessed by International Workshop Criteria (IWC)
研究概览
简要总结
This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory). To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's macroglobulinemia.
This study is being done to find doses of the combination of pralatrexate and gemcitabine with vitamin B12 and folic acid that can be safely given to patients with these types of lymphoma and explore the effectiveness of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase 1: Histologically/cytologically confirmed lymphoproliferative malignancy. Patients with Hodgkin lymphoma (HL) or non-HL are eligible, with exceptions per exclusion criteria.
- •Phase 2a: Histologically/cytologically confirmed HL, peripheral T-cell lymphoma (PTCL), or B-cell lymphoma including Waldenström's macroglobulinemia, with exceptions per exclusion criteria.
- •Progression of disease (PD) after at least 1 prior treatment (any number of prior therapies allowed). PD after last prior treatment and recovered from toxic effects of prior therapy. Patients treated with an FDA-approved monoclonal antibody therapy may be enrolled at any time after the therapy if they have PD.
- •PTCL patients must have received single-agent pralatrexate as a prior therapy.
- •Eastern Cooperative Oncology Group performance status ≤
- •Adequate blood, liver and kidney function per laboratory tests.
- •Has taken 1 mg daily oral folic acid for at least 7 days prior to planned start of pralatrexate and received 1 mg vitamin B12 intramuscularly within 10 weeks of the planned start of pralatrexate.
- •Females of childbearing potential must practice a medically acceptable contraceptive regimen from first dose until at least 30 days after last dose of pralatrexate and have a negative serum pregnancy test within 14 days prior to the first day of study treatment. Postmenopausal (defined as greater than 12 months since last menses) and surgically sterilized females do not require this test.
- •Males who are not surgically sterile must practice a medically acceptable contraceptive regimen from first dose until at least 90 days after last dose of pralatrexate.
- •Give written informed consent.
排除标准
- •B-cell: lymphoplasmacytic lymphoma (± Waldenström's macroglobulinemia); plasma cell myeloma/plasmacytoma; hairy cell leukemia.
- •PTCL: precursor T/Natural Killer (NK) neoplasms, with the exception of blastic NK lymphoma; T-cell prolymphocytic leukemia; T-cell large granular lymphocytic leukemia; mycosis fungoides (MF), except transformed MF; Sézary syndrome; primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphomatoid papulosis.
- •B-cell: plasma cell myeloma/plasmacytoma; hairy cell leukemia.
- •Relapsed HL or diffuse large B-cell lymphoma patients who are candidates for high dose therapy and autologous stem cell transplantation (SCT) and for whom it is a standard curative option.
- •Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, must be disease free for at least 5 years.
- •Congestive heart failure Class III/IV.
- •Uncontrolled hypertension.
- •Human immunodeficiency virus (HIV)- positive diagnosis with CD4 less than 100 or detectable viral load within past 3 months and receiving anti-retroviral therapy.
- •Hepatitis B or C virus with detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy.
- •Central nervous system disease.
- •Undergone an allogeneic SCT.
- •Patients with disease refractory to peripheral blood SCT, or who have relapsed less than 100 days since an autologous or peripheral blood SCT.
- •Active uncontrolled infection, underlying medical condition including unstable heart disease, or other serious illness impairing the ability to receive protocol treatment.
- •Major surgery within 2 weeks of planned start of treatment.
- •Receipt of any conventional chemotherapy or radiation therapy (encompassing greater than 10% of bone marrow) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study treatment or planned use during the study.
- •Receipt of systemic corticosteroids within 7 days of study treatment, unless on a continuous dose of no more than 10 mg/day of prednisone for at least 1 month.
- •Use of investigational drugs, biologics, or devices within 4 weeks prior to study treatment or planned use during the study.
- •Received a monoclonal antibody within 3 months without evidence of PD.
- •Previous exposure to pralatrexate and/or gemcitabine if discontinued due to treatment-related toxicity.
研究组 & 干预措施
Pralatrexate & Gemcitabine - Sequential Days
Experimental
干预措施: Pralatrexate Injection (Drug)
Pralatrexate & Gemcitabine - Sequential Days
Experimental
干预措施: Gemcitabine Hydrochloride (Drug)
Pralatrexate & Gemcitabine - Sequential Days
Experimental
干预措施: Vitamin B12 (Dietary Supplement)
Pralatrexate & Gemcitabine - Sequential Days
Experimental
干预措施: Folic Acid (Dietary Supplement)
Pralatrexate & Gemcitabine - Same Day
Experimental
干预措施: Pralatrexate Injection (Drug)
Pralatrexate & Gemcitabine - Same Day
Experimental
干预措施: Gemcitabine Hydrochloride (Drug)
Pralatrexate & Gemcitabine - Same Day
Experimental
干预措施: Vitamin B12 (Dietary Supplement)
Pralatrexate & Gemcitabine - Same Day
Experimental
干预措施: Folic Acid (Dietary Supplement)
结局指标
主要结局
Objective Responses Assessed by International Workshop Criteria (IWC)
时间窗: Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I
Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.
次要结局
- Progression-free Survival (PFS) Time(Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study)
- Duration of Response(Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study)
研究者
研究点 (15)
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