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

NCT02905942 | Unknown Phase 4

• 1 other identifier: CSPC-JYL-20150830
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Time to neutrophil engraftment

  30days

Study Arms (2)

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

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

rhG-CSF DRUG

rhG-CSF was given day +1 after transplantation with a dose of 5μg/kg once per day

rhG-CSF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jun Zhu

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhu, MD

CONTACT

+86-10-88196596; zj@bjcancer.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

CN (1)