Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02766868

Enrollment

Registered

2016-05-10

Start date

2016-01-31

Completion date

2019-07-31

Last updated

2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoblastic Leukemia, Acute, Adult

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.

Interventions

DRUGFACE-Flu/Bu/Cy

Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 59 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
disease-free survival	2 year

Countries

China

Contacts

Primary ContactJiong Hu

hujiong@medmail.com.cn86-21-64370045

Backup ContactLing Wang

cclingjar@163.com86-21-64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026