Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 9, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedAugust 1, 2016
July 1, 2016
3 years
May 9, 2016
July 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
disease-free survival
2 year
Study Arms (1)
FACE-Flu/Bu/Cy
EXPERIMENTALChemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide
Interventions
Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- liver function/renal function damage (over 2 X upper normal range)
- mental disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiong Hu
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Blood and Marrow Transplantation Program
Study Record Dates
First Submitted
May 9, 2016
First Posted
May 10, 2016
Study Start
January 1, 2016
Primary Completion
January 1, 2019
Study Completion
July 1, 2019
Last Updated
August 1, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share