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NCT04489264 Clinical Trial

The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma

Peripheral T Cell Lymphoma Clinical Trial

Official title:
A Prospective Study of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04489264
Other study ID # ASCT for PTCL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2020
Est. completion date November 30, 2025

Study information
Verified date December 2020
Source Peking University
Contact Jun Zhu, Dr.
Phone +86-13910333346
Email zhu-jun2017@outlook.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The role of autologous stem cell transplantation (ASCT) in the first remission (CR1 & PR1) of peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date November 30, 2025
Est. primary completion date November 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients with confirmed pathological diagnosis of aggressive PTCL - Age 18-65 years old - Achieving CR or PR after first-line therapy Exclusion Criteria: - Subtypes with a more indolent course, including precursor T/natural killer neoplasms, T-cell large granular lymphocytic leukemia, mycosis fungoides other than transformed mycosis fungoides, Sézary syndrome, and primary cutaneous CD30-positive disorders.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Transplant, Autologous
high dose chemotherapy followed by autologous stem cell transplantation

Locations
Country Name City State
China Beijing Cancer Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS 2-year PFS
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