Consolidation Chemotherapy After Autologous Stem Cell Tra... | NCT02306837

Studies
Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

NCT02306837

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Sep 8, 2016Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Effects of Chemotherapy

Interventions

Bu-CY-E

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

Sep 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

Sep 2014

Primary Completion Date

Sep 2018Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Dec 1, 2014

First Submission Date that Met QC Criteria

Dec 1, 2014

First Posted Date

Dec 3, 2014Estimated

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

Sep 6, 2016

Last Update Posted Date

Sep 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiong HU, Head, Blood & Marrow Transplantation Center, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation

Detailed Description

Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Consolidation chemo	Experimental	Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen	Drug: Bu-CY-E

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bu-CY-E	Drug	mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT	Consolidation chemo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival		2-year

Secondary Outcomes

Measure	Description	Time Frame
overall survival		2-year
progression	PET-CT measurement	2-year
transplantation-related mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
ECOG: 0-2
Tbil < 1.5x ULN and AST/ALT <2.5x ULN
With informed consent

Exclusion Criteria:

Life expectancy < 3 months
Women in pregnancy
uncontrollable infection disease
serum Cr >400mmol/l
uncontroled diabetis and heart disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiong Hu, M.D,	Contact	86-21-64370045	601878	hujiong@medmail.com.cn

Overall Officials

Name	Affiliation	Role
Jiong Hu, M.D,	Rui Jin Hospital, Shanghai Jiaotong Unic\versity School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine	Recruiting	Shanghai		200025	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

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Browse Branches

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