Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in Hodgkin's lymphoma and non-Hodgkin's lymphoma patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Sklodowska-Curie Institute - Oncology Center; Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Treatments: Cytarabine; Lenograstim

Criteria

Inclusion Criteria:

1. Hodgkin's lymphoma and non-Hodgkin's lymphoma patients considered eligible for autologous stem cell transplantation procedure.

2. Must not have achieved complete remission after first line of therapy or must have relapsed lymphoma.

3. Must have received at least two lines of therapy including four or more cycles.

4. Must have achieved a partial (PR) or complete remission (CR) .

5. Must be 18-65 years of age.

6. Must have World Health Organization performance status 0-1.

7. Time from administration or discontinuation of any chemotherapy agent must be at least four weeks.

8. Hemoglobin level > 8 g/dl, Absolute neutrophil count (ANC) > 1.5 x 10^9/L, Platelet count >100 x 10^9/L.

9. Serum creatinine < 1.5 x upper limit of normal (ULN), serum bilirubin < 1.5 ULN, serum aspartate transaminase (AST/SGOT) < 2.5 x ULN, serum alanine transaminase (ALT/SGPT) < 2.5 x ULN.

10. Negative human immunodeficiency virus (HIV) infection test.

11. Negative pregnancy test.

12. Must understand and voluntarily sign informed consent form.

Exclusion Criteria:

1. Failure of prior, first-line mobilization regimen.

2. Infiltration of central nervous system.

3. Bone marrow plasma cell infiltration of above 20%.

4. Administration of nitrosourea derivatives (Carmustine, Lomustine) within 4 weeks before starting study treatment.

5. Administration of growth-factor other than G-CSF Administration of G-CSF within 14 days before starting study treatment.

6. Ongoing or active infection.

7. Coexisting neoplasm, other than Hodgkin's or non-Hodgkin's lymphoma.

8. Administration of radioimmunotherapy in past.

9. Pregnant or lactating females.

10. Patients treated with use of autologous or allogenic stem cell transplantation in the past.

11. Positive human immunodeficiency virus (HIV) infection test.