Lymphoblastic Leukemia, Acute, Adult Clinical Trial
Official title:
Sequential Intensive Chemotherapy With Reduced Intensity Conditioning Regimen in Adult Patients With Refractory and Relapse Acute Lymphoblastic Leukemia
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 59 Years |
Eligibility |
Inclusion Criteria: - adult patients with refractory or relapse acute lymphoblastic leukemia not in remission after 2 cycles of induction chemotherapy early relapse (1st remission less than 6 months) not in remission after 1 cycle of re-induction chemotherapy multiple relapse - age 16-60 years with inform consent - no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage - HLA matched related (6/6), unrelated donors (8~10/10) or haplo Exclusion Criteria: - liver function/renal function damage (over 2 X upper normal range) - mental disease |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Blood & Marrow Transplantation Center, RuiJin Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease-free survival | 2 year | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04554485 -
Blinatumomab Followed by High-dose Chemotherapy for Ph-negative Acute Lymphoblastic Leukemia (ALL)
|
Phase 2 |