NCT02360111终止不适用
A Pilot Trial of GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- # GVHD (Grade II-IV) Chronic GVHD Will be Diagnosed and Graded According to the (NIH Criteria)
研究概览
简要总结
This is a pilot study which will be done in a small number of patients. The purpose of this study is to test the safety and benefit of giving a type of chemotherapy - cyclophosphamide - after the transplant to prevent graft versus host disease (GVHD) in patients with abnormal kidney function. GVHD is one of the most common complications of a stem cell transplant .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 是
入选标准
- •Age: Patients over age 18 who are deemed eligible for transplant by their treating physician.
- •Disease status:
- •AML in ≥ 1st remission - excluding those in 1st remission with 'good risk' cytogenetic features (i.e. t(8;21), t(15;17), inv 16).
- •Secondary AML
- •ALL/LL in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL > 2nd remission
- •CML failing to respond to, progressing on or not tolerating appropriate TKI therapy in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
- •Non-Hodgkins lymphoma with chemoresponsive disease in any of the following categories:
- •high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants or transplants requiring the use of calcineurin inhibitors.
- •any NHL with therapy responsive disease which is considered not curable outside the transplant setting and not eligible/appropriate for autologous transplant or a higher priority protocol.
- •Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or transfusion dependence, RAEB-1 and RAEB-2 and AML evolved from MDS, who are not eligible for a higher priority protocol.
- •Chronic myelomonocytic leukemia: CMML-1 and CMML-2, advanced polycythemia vera, and myelofibrosis.
- •Patients must have a healthy HLA compatible (8/8 molecularly matched related, or unrelated) donor willing to undergo BM harvesting or PBSC apheresis after G-CSF administration. BM will be the preferred graft source.
- •Patients diagnosed with any form of acute leukemia must have received induction and at least one course of consolidation chemotherapy pretransplant
- •Patients must have a Karnofsky Performance Status > 70%
- •Patients will have a eGFR <60 ml/min/1.73 m2
- •Patients must have adequate organ function measured by: Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 50% and must improve with exercise.
- •Hepatic: ALT < 3 x ULN and total serum bilirubin < 1.5 x ULN, unless there is congenital benign hyperbilirubinemia
- •Renal: eGFR > 30 ml/min/1.73 m2
- •Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected for hemoglobin)
- •Each patient must be willing to participate as a research subject and must sign an informed consent form.
- •Patient must have a fully matched related or unrelated donor willing to donate stem cells.
排除标准
- •Major surgery or irradiation within two weeks.
- •Active CNS or extramedullary malignant disease.
- •Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or HIV infection
- •Pregnant or lactating women - they are excluded, given the potential teratogenic effects of chemotherapy and agents used in the transplant.
- •Male and female patients of child-bearing potential unwilling to use effective means of contraception
- •HIV or HTLV I/II positive, hepatitis C or chronic active hepatitis B.
- •Patients who have had a previous malignancy unless they are deemed by their treating physicians to be at low risk for recurrence.
- •Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research tests.
研究组 & 干预措施
Post Transplant Cyclophosphamide
Experimental
Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
# GVHD (Grade II-IV) Chronic GVHD Will be Diagnosed and Graded According to the (NIH Criteria)
时间窗: 2 years
Chronic GVHD will be diagnosed and graded according to the (NIH criteria) treated with standard or experimental immunosuppressive therapy.
次要结局
- The Occurrence of Life-threatening Opportunistic Infections(2 years)
- Overall Survival(2 years)
- Disease-free Survival(2 years)
- # Renal Insufficiency Defined as a Calculated eGFR <60 ml/Min/1.73m2. Those With a eGFR < 30 ml/Min/1.73m2 Will be Considered Ineligible.(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune SuppressionGraft Vs Host DiseaseGVHDNCT02891603H. Lee Moffitt Cancer Center and Research Institute40
终止
2 期
Prevention of the Graft-Versus-Host-Disease in Patients After Stem Cell Transplantation With Tacrolimus and EverolimusGraft vs Host DiseaseNCT00117702Technische Universität Dresden24
已完成
不适用
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)Sleep Apnea SyndromesSleep Apnea, ObstructiveRespiration DisordersSigns and Symptoms, RespiratorySyndrome, Obstructive Sleep ApneaNCT01532180ImThera Medical, Inc.14
已完成
2 期
Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)Graft vs Host DiseaseImmune System DisordersNCT00224874National Heart, Lung, and Blood Institute (NHLBI)180
已完成
3 期
Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell TransplantAggressive Non-Hodgkin LymphomaAcute Myeloid LeukemiaDiffuse Large B-Cell LymphomaHematopoietic and Lymphoid Cell NeoplasmIndolent Non-Hodgkin LymphomaMyeloproliferative NeoplasmRecurrent Chronic Lymphocytic LeukemiaRecurrent Plasma Cell MyelomaRefractory Chronic Lymphocytic LeukemiaRefractory Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRefractory Hodgkin LymphomaSmall Lymphocytic LymphomaT-Cell Chronic Lymphocytic LeukemiaWaldenstrom MacroglobulinemiaChronic Lymphocytic LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeMantle Cell LymphomaProlymphocytic LeukemiaNCT01231412Fred Hutchinson Cancer Center174