Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse ALL

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02766868
• Other study ID #: RJH-2015-RefactoryALL-SCT
• Status: Recruiting
• Phase: Phase 2
• First received: May 9, 2016
• Last updated: July 28, 2016
• Start date: January 2016
• Est. completion date: July 2019

Study information

• Verified date: July 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jiong Hu
• Phone: 86-21-64370045
• Email: hujiong[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia, Acute, Adult
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• FACE-Flu/Bu/Cy
Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		2 year	Yes