Study of Standard and Individualized Treatment Model for... | NCT02929615

Studies
Study of Standard and Individualized Treatment Model for Relapse and Refractory Lymphatic System Malignant Tumors

NCT02929615

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Oct 12, 2016Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Lymphoma

Interventions

Hematopoietic stem cell transplantation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Sep 27, 2016

First Submission Date that Met QC Criteria

Oct 7, 2016

First Posted Date

Oct 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 12, 2016Estimated

Description Module

Brief Summary

The purpose of the study is to research the standard and individualized treatment model for relapse and refractory lymphatic system malignant tumors.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Treatment group	Experimental		Other: Hematopoietic stem cell transplantation

Name	Type	Description	Arm Group Labels	Other Names
Hematopoietic stem cell transplantation	Other		Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall response rate		2 years after treatment
complete response		2 years after treatment
progression-free survival		2 years after treatment
overall survival		2 years after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with relapse and refractory lymphoma and multiple myeloma.
At least 1 measurable lesions and its size≥15mm.
Patients ≤65 years，no limitations for both gender.
ECOG score is 0-1.
Life expectancy≥3 months.
LVEF≥ 55%; Peripheral blood: WBC ≥ 3.5×10(9)/L,neutrophil ≥1.5×10(9)/L, PLT≥75×109/L，Hb≥90g/L; Renal function: Cr≤2.0×UNL; Liver function: BIL≤2.0×UNL，ALT/AST≤2.5×UNL;
Written informed consent are acquired.

Exclusion Criteria:

Previously received stem cell transplantation.
Women with pregnant, lactating or not to take contraceptive measures.
Severe acute infection or suppurative and chronic infection that wound not healing.
Severe heart failure.
Suffering from mental disorders and poor compliance.
Other situations that investigators consider as contra-indication for this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhu Jun, archiater	Contact	010-88196596		Zhujun@csco.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
	Recruiting	Beijing	Beijing Municipality	100142	China

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018380	Hematopoietic Stem Cell Transplantation

Ancestor Terms

ID	Term
D033581	Stem Cell Transplantation
D017690	Cell Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy

Browse Leaves

Not provided

Browse Branches

Not provided