CTRI/2020/09/027731招募中2 期
Reduced Toxicity and Reduced Intensity conditioning regimen using Fludarabine and Treosulfan for high risk hematological malignancies undergoing allogenic hematopoietic cell transplantation - RIC FT-10
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients with Advanced or high-risk Hematological Cancers:
- •oAcute Myeloid Leukemia (AML): intermediate and high risk cytogenetics and molecular markers [as defined by ELNet and periodically updated, inclusive but not restricted to Complex karyotype, monosomy 7, Philadelphia positive, any of inv(3) or t(3;3), t(6;9), +8 alone, MLL gene rearranged; secondary AML, FAB M6/M7 leukemia]; in CR1 and AML with greater than one induction cycle required for remission(CR2).
- •oHigh risk Myelodysplastic Syndrome [MDS with adverse cytogenetics defined by IPSS (and periodically updated), MDS with excess blasts, MDS with Multilineage dysplasia]
- •oRelapsed or Refractory Lymphomas, which are chemo-sensitive [defined as a complete or partial response to salvage systemic therapies administered pre- transplantation]
- •oRare high-risk histologies like Blastic Plasmacytoid Dendritic Cell Neoplasm, etc. can be considered if in complete remission / response
- •oHigh risk Acute Lymphoblastic Leukemia in remission and not eligible for myeloablative conditioning therapies
- •oCML in Myeloid blast crisis and in CR or chronic phase, pre-transplant
- •3.HLA matched, haplo-identical and partially mismatched, related or unrelated donor available
- •4.Patients must have received antineoplastic therapy within 3 months of consent date (measured from the start date of antineoplastic therapy).
- •5.Left ventricular ejection fraction >= 40%;
- •6.Pulmonary function: DLCO (carbon monoxide corrected diffusion lung capacity), FEV1 (forced expiratory volume in the first second), or FVC (functional vital capacity) 50% of predicted;
- •7.Liver function: total bilirubin < 2.5 mg/dL and aspartate and alanine aminotransferases and alkaline phosphatase <5 x the upper limit of normal;
- •8.Renal function: Serum creatinine within the normal range for age or measured creatinine clearance or calculated glomerular filtration rate 40 mL/min/1.73 sq.m
- •9.ECOG performance score of 0-2
- •10.HCT Co-morbidity Index: Low and Intermediate risk score (0-2)
- •11.Study treatment both planned and able to start within 4-6 weeks of registration
- •12.Tissue sample available
排除标准
- •1.Acute Leukemias not in complete morphological remission, and relapsed refractory Lymphomas with less than partial response.
- •2.Autologous hematopoietic transplant < 3 months prior to enrolment
- •3.Pregnancy or breast feeding
- •4.Evidence of HIV infection or known HIV positive serology
- •5.Current uncontrolled bacterial, viral or fungal infection: currently taking medications, or with evidence of progression of clinical symptoms or radiologic findings)
- •6.Patients with history of primary idiopathic myelofibrosis
- •7.Contraindications to any of the drug used
- •8.Serious psychiatric conditions that might limit the ability of the patient to comply with the protocol
- •9.Prior allogeneic hematopoietic cell transplantation
研究者
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