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

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEG-rhG-CSF

Patients in PEG-rhG-CSF group received PEG-rhG-CSF day +1 after transplantation.

Group Type EXPERIMENTAL

PEG-rhG-CSF

Intervention Type 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.

rhG-CSF

Patients in control group received rhG-CSF day +1 after transplantation.

Group Type ACTIVE_COMPARATOR

rhG-CSF

Intervention Type DRUG

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

Interventions

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PEG-rhG-CSF

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.

Intervention Type DRUG

rhG-CSF

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No