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

NCT ID: NCT04489264

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral T Cell Lymphoma

Keywords

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Autologous Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ASCT group

patients who achieved CR or PR after 6-8 cycles first-line therapy receive ASCT as consolidation therapy

Transplant, Autologous

Intervention Type DRUG

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

No interventions assigned to this group

Interventions

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Transplant, Autologous

high dose chemotherapy followed by autologous stem cell transplantation

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Jun Zhu

Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Zhu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Beijing Cancer Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Zhu, Dr.

Role: CONTACT

Phone: +86-13910333346

Email: [email protected]

Facility Contacts

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Meng Wu

Role: primary

Other Identifiers

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ASCT for PTCL

Identifier Type: -

Identifier Source: org_study_id