EUCTR2015-000602-18-DE进行中（未招募）1 期
A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus Host-Disease - CNI-Free GvHD Prophylaxis
ational Heart, Lung, and Blood Institute (NHLBI)0 个研究点目标入组 345 人开始时间: 2015年10月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 345
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. Males and females aged = 1.0 year and < 66.0 years
- •2. Patients with acute leukemia in morphologic complete remission with or without hematologic recovery or with myelodysplasia (MDS) with no circulating blasts and with less than 5% blasts in the bone marrow. Patients with CMML must have a WBC count =10,000 cells/µL and <5% blasts in the marrow. Patients with = 5% blasts due to a regenerating marrow must contact the protocol chairs for review.
- •3. Planned myeloablative conditioning regimen (see eligible regimens in Table 2.4)
- •4. Patients must have a related or unrelated donor as follows:
- •a. Related donor must be an 8/8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing. Pediatric related donors must weigh = 25.0 kg., must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter, must be willing to (1) donate bone marrow and (2) receive G-CSF followed by donation of peripheral blood stem cells (product to be determined by randomization post enrollment) and must meet institutional criteria for donation1.
- •b. Unrelated donor must be an 8/8 match at HLA-A, -B, -C and –DRB1 at high resolution using DNA-based typing. Unrelated donor must be medically eligible to donate according to NMDP (or equivalent donor search organization) criteria. At time of enrollment, the donor should not have any known preferences or contraindications to donate bone marrow or peripheral blood stem cells .
- •i. Selection of unrelated donors is to be performed according to institutional practice. It is recommended that the time from collection to initiation of the cell processing be considered when prioritizing donors, as data shows better results for CD34 selection when cell processing begins within 36 hours of the end of collection as indicated in section 2.5.1.2.
- •5. Cardiac function: Ejection fraction at rest =45.0% or shortening fraction of = 27.0% by echocardiogram or radionuclide scan (MUGA).
- •6. Estimated creatinine clearance (for patients > 12 years) greater than 50.0 mL/minute (using the Cockcroft-Gault formula and actual body weight); for pediatric patients (= 1 year to 12 years), GFR estimated by the updated Schwartz formula = 90.0 mL/min/1.73 m2. If the estimated creatinine clearance is < 90 mL/min/1.73 m2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 70.0 mL/min/1.73 m2.
- •7. Pulmonary function: DLCO =50% (adjusted for hemoglobin), and FVC and FEV1=50%; for children who are unable to perform for PFTs due to age or developmental ability, there must be no evidence of dyspnea and no need for supplemental oxygen, as evidenced by O2 saturation = 92% on room air.
- •8. Liver function: total bilirubin < 2x the upper limit of normal (unless elevated bilirubin is attributed to Gilbert’s Syndrome) and ALT/AST < 2.5x the upper limit of normal.
- •9. Signed informed consent.
- •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 345
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior autologous or allogeneic hematopoietic stem cell transplant
- •2. Karnofsky or Lansky Performance Score < 70%
- •3. Active CNS involvement by malignant cells
- •4. Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment
- •5. Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
- •6. Patients seropositive for HIV-1 or -2
- •7. Patients seropositive for HTLV-I or -II
- •8. Patients with active Hepatitis B or C viral replication by PCR
- •9. Documented allergy to iron dextran or murine proteins
- •10. Women who are pregnant (positive serum or urine ßHCG) or breastfeeding
- •11. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use 2 effective forms of birth control or abstinence for one year after transplantation
- •12. History of uncontrolled autoimmune disease or on active treatment
- •13. Patients with prior malignancies, except resected non-melanoma or treated cervical carcinoma in situ. Cancer treated with curative intent = 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs.
- •14. Patient unable to comply with the treatment protocol including appropriate supportive care, follow-up and research tests
- •15. Planned post-transplant maintenance therapy except for FLT3 inhibitors or TKIs
- •a. Must be declared prior to randomization.
- •16. If it is known prior to enrollement that the hematopoietic stem cell product will need to be cryopreserved, the patient should not be enrolled.
- •17. German centers only: Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or participation in any other interventional clinical study.
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