The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
Sponsor
Peking University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04489264
Collaborator
(none)
60
1
60
1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Study of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
Anticipated Study Start Date
:
Nov 30, 2020
Anticipated Primary Completion Date
:
Nov 30, 2023
Anticipated Study Completion Date
:
Nov 30, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ASCT group patients who achieved CR or PR after 6-8 cycles first-line therapy receive ASCT as consolidation therapy |
Drug: Transplant, Autologous
high dose chemotherapy followed by autologous stem cell transplantation
|
| Observation group patients who achieved CR or PR after 6-8 cycles first-line therapy finish their therapy and go into follow-up |
Outcome Measures
Primary Outcome Measures
- PFS [2-year PFS]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Cancer Hospital | Beijing | China | 100142 |
Sponsors and Collaborators
- Peking University
Investigators
- Principal Investigator: Jun Zhu, Dr., Peking University Cancer Hospital & Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jun Zhu,
Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine,
Peking University
ClinicalTrials.gov Identifier:
NCT04489264
Other Study ID Numbers:
- ASCT for PTCL
First Posted:
Jul 28, 2020
Last Update Posted:
Dec 4, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jun Zhu,
Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine,
Peking University
Additional relevant MeSH terms: