Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

Effects of Chemotherapy Clinical Trial

Official title:

A Phase II Trial of Consolidation Chemothetapy for Patients With Relapse or Refractory Lymphoid Malignancies After Autologous Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306837
• Other study ID #: Lym-Auto-RJH-2014
• Status: Recruiting
• Phase: Phase 2
• First received: December 1, 2014
• Last updated: September 6, 2016
• Start date: September 2014
• Est. completion date: September 2019

Study information

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

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Effects of Chemotherapy

Intervention

Drug:
• Bu-CY-E
mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT

Locations

Country	Name	City	State
China	Rui Jin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai
China	Shanghai No 10 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	progression free survival		2-year	No
Secondary	overall survival		2-year	Yes
Secondary	progression	PET-CT measurement	2-year	No
Secondary	transplantation-related mortality		2-year	Yes