PEG-rhG-CSF in Lymphoma Patients After Autologous Hematop... | NCT02905942

Studies
PEG-rhG-CSF in Lymphoma Patients After Autologous Hematopoietic Stem Cell Transplantation

NCT02905942

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Sep 19, 2016Estimated

Enrollment

96Estimated

Phase

Phase 4

Conditions

Lymphoma

Interventions

PEG-rhG-CSF
rhG-CSF

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

Dec 2015

Primary Completion Date

Dec 2018Estimated

Completion Date

Not provided

First Submitted Date

Sep 14, 2016

First Submission Date that Met QC Criteria

Sep 16, 2016

First Posted Date

Sep 19, 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

Sep 16, 2016

Last Update Posted Date

Sep 19, 2016Estimated

Description Module

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF on the recovery of hematopoietic function after autologous stem cell transplantation in patients with lymphoma.

Detailed Description

At present, there is few related research of Recombinant Human Granulocyte Colony-stimulating Factor applying to AHSCT in China. The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in lymphoma patients after autologous hematopoietic stem cell transplantation. Eligible patients were randomly assigned to PEG-rhG-CSF group or rhG-CSF group. Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation with a dose of 100μg/kg. Patients with the weight more than 45kg were suggested a dose of 6 mg. Patients in control group received rhG-CSF day +1 after transplantation with a dose of 5μg/kg once per day until the recovery of neutrophil.

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

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEG-rhG-CSF	Experimental	Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation.	Drug: PEG-rhG-CSF
rhG-CSF	Active Comparator	Patients in control group received rhG-CSF day +1 after transplantation.	Drug: rhG-CSF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEG-rhG-CSF	Drug	PEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 100μg/kg(bw).For patients more than 45kg, 6mg was suggested.	PEG-rhG-CSF

Measure	Description	Time Frame
Time to neutrophil engraftment		30days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with age between 18 and 65 years.
Lymphoma patients with the requirement for autologous hematopoietic stem cell transplantation.
The collected CD34+ cells≥1×10E6/kg.
ECOG score ≤2.
Heart and lung is normal.
Blood creatinine ≤1.5×ULN.
ALT, AST, TBIL ≤2 ×ULN
Not in pregnancy.
Written informed consent are acquired.

Exclusion Criteria:

Had received autologous hematopoietic stem cell transplantation or allogeneic transplantation.
Severe or uncontrolled infectious diseases: HIV, HCV, syphilis, ALT, chronic hepatitis B.
Serious complications, such as severe infection, heart, lung, liver and kidney dysfunction.
LVEF <55%.
Allergic to the product or other biological products from genetically engineered Escherichia coli strains.
Refused to take contraceptive measures during the study period and the subsequent 1 years.
Severe mental or neurological disorders.
Serious heart, lung, central nervous system disorders.
Sickle cell anemia, hemolytic anemia and other hematologic diseases.
Participate in other drugs clinical trials 30 days before the screening.
Other situation 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

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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