A Phase 2 interventional study of FACE-Flu/Bu/Cy in Lymphoblastic Leukemia, Acute, Adult, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 16 Years to 59 Years. Per ClinicalTrials.gov, last updated 2016-08-01.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment
Patients with refractory and relapse lymphoblastic leukemia had poor outcome even with marrow ablative conditioning mostly standard iv-Bu-Cy or Cy-TBI. In this study, we focus on a new treatment strategy with high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+cyclophosphamide+etoposide followed by reduced intensity condiotning regimen consisting of fludarabine, busulfan and post-infusion cyclophophamide.
All patients with refractory and relapse lymphoblastic leukemia will receive a high-dose chemotherapy regimen consisting of fludaraibine+cytarabine+ cyclophosphamide+etoposide. At day 7 after chemo, a bone marrow aspiration and MRD study by flow-cytometry is planned. For those patients with no residual blasts will undergo allogeneic stem cell transplantation with reduced intensity condiotning regimen consisting of 5-day fludarabine and 3-day busulfan and post-infusion cyclophophamide (D+3 and +4) as GVHD prophylaxis.
5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's planned enrollment of 20 is below the median of 38 across 4,248 interventional studies indexed under Leukemia.
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Exclusion Criteria:
Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide
Drug: FACE-Flu/Bu/Cy
Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide
Also known as: FACE-chemo-FLu-BU-CY conditioning
disease-free survival
Time frame: 2 year
Plan to share: No
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This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine