The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
A Prospective Study of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedDecember 4, 2020
December 1, 2020
3 years
July 23, 2020
December 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS
2-year PFS
Study Arms (2)
ASCT group
patients who achieved CR or PR after 6-8 cycles first-line therapy receive ASCT as consolidation therapy
Observation group
patients who achieved CR or PR after 6-8 cycles first-line therapy finish their therapy and go into follow-up
Interventions
high dose chemotherapy followed by autologous stem cell transplantation
Eligibility Criteria
lymphoma patients in several hospitals in China
You may qualify if:
- Patients with confirmed pathological diagnosis of aggressive PTCL
- Age 18-65 years old
- Achieving CR or PR after first-line therapy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, 100142, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Zhu, Dr.
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine
Study Record Dates
First Submitted
July 23, 2020
First Posted
July 28, 2020
Study Start
November 30, 2020
Primary Completion
November 30, 2023
Study Completion
November 30, 2025
Last Updated
December 4, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share