Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT02722733
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02722733
Study Brief:
Protocol Section:
NCT02722733