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

Peking University

Status and phase: Unknown; Phase 4

Conditions: Lymphoma

Treatments: Drug: rhG-CSF; Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT02905942

CSPC-JYL-20150830

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

PEG-rhG-CSF

Experimental group

Description:

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

Treatment:

Drug: PEG-rhG-CSF

rhG-CSF

Active Comparator group

Description:

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

Treatment:

Drug: rhG-CSF