NCT00800150终止1 期
Phase I Study of Escalating Doses of Radiation Therapy Using Helical Tomotherapy in Combination With Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) Transplantation in Patients With Advanced and Hematological Malignancies Who Are Not Eligible for Fully Myeloablative Regimen
City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation using helical tomotherapy
研究概览
简要总结
RATIONALE: Giving total marrow and total lymph node irradiation together with low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase I trial is studying the side effects and best dose of total marrow and total lymph node irradiation when given together with fludarabine and melphalan followed by donor stem cell transplant in treating patients with advanced hematological cancer that has not responded to treatment.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation (TMLI) using helical tomotherapy in combination with a reduced-intensity preparative regimen comprising fludarabine phosphate and melphalan in patients undergoing allogeneic hematopoietic stem cell transplantation for advanced, relapsed or refractory hematological malignancies.
- To describe the toxicities of escalating doses of TMLI in these patients.
Secondary
- To describe the frequency of clinical response in patients treated with this regimen.
- To describe the frequency of primary and secondary engraftment failure in patients treated with this regimen.
- To describe the time to neutrophil and platelet engraftment in patients treated with this regimen.
- To describe the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.
- To describe the overall survival of patients treated with this regimen.
- To describe the progression-free survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histopathologically confirmed diagnosis of 1 of the following:
- •Acute myeloid leukemia (AML)
- •Myelodysplastic syndromes
- •Intermediate- or high-risk disease
- •Myelofibrosis
- •Granulocytic sarcoma (chloroma)
- •With or without bone marrow involvement
- •Mixed lineage leukemia
- •Induction therapy must have been directed predominantly against AML
- •Acute lymphoblastic leukemia
- •Non-Hodgkin lymphoma
- •Multiple myeloma
- •Relapsed or refractory disease with M3 marrow (marrow blasts > 25%), meeting 1 of the following criteria:
- •Persistent disease after an induction attempt
- •Persistent initial disease after two induction attempts
- •Relapse after one re-induction attempt (second relapse)
- •Persistent disease after first relapse and initial re-induction attempt
- •Not eligible for myeloablative allogeneic hematopoietic stem cell transplantation due to age (> 50 years), organ insufficiency, or significant comorbidity
- •Patients 16-50 years of age must meet ≥ 1 of the following criteria:
- •Ejection fraction 50-60% by MUGA scan and/or echocardiogram
- •DLCO 50-75% of predicted
- •Creatinine clearance or GFR 60-80 mL/min
- •Serum bilirubin ≤ 2.0 mg/dL
- •SGOT and SGPT 1.5-5 times upper limit of normal
- •No other medical and/or psychosocial problem that, in the opinion of the primary physician or principal investigator, would place the patient at unacceptable risk from study regimen
- •No Fanconi anemia
- •HLA-identical sibling OR matched unrelated donor available
- •PATIENT CHARACTERISTICS:
- •Zubrod or Karnofsky performance status 70-100%
- •Negative pregnancy test
- •Able to lie supine in a full body cast for 30 minutes
- •No HIV infection
- •No evidence of active hepatitis B or C infection
- •No evidence of cirrhosis
- •No uncontrolled viral, bacterial, or fungal infection within the past 4 weeks
- •No radiographic changes indicating pulmonary disease (e.g., pulmonary nodules, infiltrates, or pleural effusion) unless cleared by pulmonary biopsy that shows no evidence of active pulmonary disease
- •No major medical or psychiatric disorder that would seriously compromise patient tolerance of study regimen
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior radiation therapy
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation using helical tomotherapy
Toxicity
次要结局
- Time to neutrophil and platelet engraftment
- Incidence of acute and chronic graft-versus-host disease
- Progression-free survival
- Frequency of clinical response
- Frequency of primary and secondary engraftment failure
- Overall survival
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Total Marrow and Lymphoid Irradiation and Chemotherapy Before Donor Transplant in Treating Patients With Myelodysplastic Syndrome or Acute LeukemiaAdult Acute Lymphoblastic Leukemia in Complete RemissionAcute Myeloid Leukemia in RemissionPreviously Treated Myelodysplastic SyndromeRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaChildhood Acute Lymphoblastic Leukemia in Complete RemissionNCT02446964City of Hope Medical Center31
暂停
1 期
Total Marrow and Lymphoid Irradiation, Fludarabine, and Melphalan Before Donor Stem Cell Transplant in Treating Participants With High-Risk Acute Leukemia or Myelodysplastic SyndromeAcute Lymphoblastic Leukemia in RemissionAcute Myeloid LeukemiaAcute Myeloid Leukemia in RemissionHematopoietic Cell Transplantation RecipientSecondary Acute Myeloid LeukemiaMinimal Residual DiseaseAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeNCT03494569City of Hope Medical Center36
终止
1 期
IMRT-TMI With Fludarabine as Myeloablative Conditioning for Allogeneic HSCTChronic Myeloid LeukemiaAcute Lymphocytic LeukemiaMyelodysplastic SyndromesAcute Myeloid LeukemiaNCT03696537Naoyuki G. Saito, M.D., Ph.D.6
进行中（未招募）
2 期
Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute LeukemiaAcute Myeloid LeukemiaHigh Risk Myelodysplastic SyndromeMyelodysplastic SyndromeAcute Lymphoblastic LeukemiaNCT04262843City of Hope Medical Center33
已完成
1 期
Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Patients With Hematologic MalignanciesHematologic MalignanciesAcute Lymphocytic LeukemiaNon Hodgkin LymphomaChronic Myeloid LeukemiaMultiple MyelomaAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaMyeloproliferative SyndromeMyelodysplastic SyndromeHodgkin LymphomaMyelofibrosisNCT02129582Case Comprehensive Cancer Center14