Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 2

Conditions: Effects of Chemotherapy

Treatments: Drug: Bu-CY-E

Study type: Interventional

Funder types: Other

Identifiers

NCT02306837

Lym-Auto-RJH-2014

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Consolidation chemo

Experimental group

Description:

Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen

Treatment:

Drug: Bu-CY-E