Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Sequential Intensive Chemotherapy With Reduced Intensity Conditioning Regimen in Adult Patients With Refractory and Relapse Acute Lymphoblastic Leukemia

Conditions
-----------------
Lymphoblastic Leukemia, Acute, Adult

Intervention / Treatment
-----------------
* Drug: FACE-Flu/Bu/Cy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FACE-Flu/Bu/Cy<br>Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide | Drug: FACE-Flu/Bu/Cy<br>* Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide<br>* Other names: FACE-chemo-FLu-BU-CY conditioning;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 2 year |