Back to resultsSequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL
Primary Purpose
Lymphoblastic Leukemia, Acute, Adult
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
FACE-Flu/Bu/Cy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoblastic Leukemia, Acute, Adult
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
Sites / Locations
- Blood & Marrow Transplantation Center, RuiJin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FACE-Flu/Bu/Cy
Arm Description
Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide
Outcomes
Primary Outcome Measures
disease-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT02766868
First Posted
May 9, 2016
Last Updated
July 28, 2016
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02766868
Brief Title
Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL
Official Title
Sequential Intensive Chemotherapy With Reduced Intensity Conditioning Regimen in Adult Patients With Refractory and Relapse Acute Lymphoblastic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoblastic Leukemia, Acute, Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FACE-Flu/Bu/Cy
Arm Type
Experimental
Arm Description
Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
FACE-Flu/Bu/Cy
Other Intervention Name(s)
FACE-chemo-FLu-BU-CY conditioning
Intervention Description
Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiong Hu
Phone
86-21-64370045
Ext
601818
Email
hujiong@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Wang
Phone
86-21-64370045
Ext
601818
Email
cclingjar@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiong Hu
Organizational Affiliation
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blood & Marrow Transplantation Center, RuiJin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Wang
Phone
86-21-64370045
Ext
601818
Email
cclingjar@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL
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