Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

Phase 2

• Conditions: Effects of Chemotherapy
• Interventions: Drug: Bu-CY-E

• Registration Number: NCT02306837
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation

Detailed Description

Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-08
• Primary Completion: 2018-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
• ECOG: 0-2
• Tbil < 1.5x ULN and AST/ALT <2.5x ULN
• With informed consent

Exclusion Criteria

• Life expectancy < 3 months
• Women in pregnancy
• uncontrollable infection disease
• serum Cr >400mmol/l
• uncontroled diabetis and heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Consolidation chemo	Bu-CY-E	Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen

Primary Outcome Measures

Name	Time	Method
progression free survival	2-year

Secondary Outcome Measures

Name	Time	Method
overall survival	2-year
progression	2-year	PET-CT measurement
transplantation-related mortality	2-year

Trial Locations

Locations (2)

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, China

Shanghai No 10 Hospital; 🇨🇳 Shanghai, China