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Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02306837
Enrollment
40
Registered
2014-12-03
Start date
2014-09-30
Completion date
2019-09-30
Last updated
2016-09-08

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

Conditions

Effects of Chemotherapy

Keywords

lymphoma, consolidation chemotherapy, auto-HSCT

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.

Interventions

DRUGBu-CY-E

mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
progression free survival2-year

Secondary

MeasureTime frameDescription
overall survival2-year
progression2-yearPET-CT measurement
transplantation-related mortality2-year

Countries

China

Contacts

Primary ContactJiong Hu, M.D,
hujiong@medmail.com.cn86-21-64370045

Outcome results

None listed

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