Clinical trial · Interventional
Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Safety and Efficacy of Stem Cell Mobilization Using G-CSF (Filgrastim) Alone Compared to Intermediate-dose Cytosine Arabinoside Plus G-CSF in Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma Patients.
NCT02722733CI-TRIAL-00021550unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytosine arabinoside with G-CSF (filgrastim) | Drug | — | UNRESOLVED |
| G-CSF (filgrastim) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- G-CSF (filgrastim)
- description
- 1.G-CSF at 10 μg/kg per day (divided into two doses every 12 hours) subcutaneously for up to 7 days.
- interventionNames
- Drug: G-CSF (filgrastim)
- type
- ACTIVE_COMPARATOR
- label
- Cytosine arabinoside + G-CSF (filgrastim)
- description
- 1. Cytosine arabinoside will be administered as a 2-hour i.v. infusion at a dose of 0.4 g/m2 twice daily on days 1 and 2 (total dose 1.6 g/m2). 2. G-CSF 5-10 μg/kg per day (divided into two doses every 12 hours) will be started on day 5 subcutaneously and continued until last leukapheresis.
- interventionNames
- Drug: Cytosine arabinoside with G-CSF (filgrastim)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDNarayanasami U, Kanteti R, Morelli J, Klekar A, Al-Olama A, Keating C, O'Connor C, Berkman E, Erban JK, Sprague KA, Miller KB, Schenkein DP. Randomized trial of filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells for rescue in autologous transplantation. Blood. 2001 Oct 1;98(7):2059-64. doi: 10.1182/blood.v98.7.2059. PMID 11567990
- BACKGROUNDKaranth M, Chakrabarti S, Lovell RA, Harvey C, Holder K, McConkey CC, McDonald D, Fegan CD, Milligan DW. A randomised study comparing peripheral blood progenitor mobilisation using intermediate-dose cyclophosphamide plus lenograstim with lenograstim alone. Bone Marrow Transplant. 2004 Sep;34(5):399-403. doi: 10.1038/sj.bmt.1704598. PMID 15273706
- BACKGROUNDSheppard D, Bredeson C, Allan D, Tay J. Systematic review of randomized controlled trials of hematopoietic stem cell mobilization strategies for autologous transplantation for hematologic malignancies. Biol Blood Marrow Transplant. 2012 Aug;18(8):1191-203. doi: 10.1016/j.bbmt.2012.01.008. Epub 2012 Jan 16. PMID 22261379
- BACKGROUNDKruzel T, Sadus-Wojciechowska M, Najda J, Czerw T, Glowala-Kosinska M, Holowiecki J, Giebel S. Very high efficacy of intermediate-dose cytarabine in combination with G-CSF as a second-line mobilization of hematopoietic stem cells. Int J Hematol. 2012 Aug;96(2):287-9. doi: 10.1007/s12185-012-1135-5. Epub 2012 Jul 14. No abstract available. PMID 22797877
- BACKGROUNDGiebel S, Kruzel T, Czerw T, Sadus-Wojciechowska M, Najda J, Chmielowska E, Grosicki S, Jurczyszyn A, Pasiarski M, Nowara E, Glowala-Kosinka M, Chwieduk A, Mitrus I, Smagur A, Holowiecki J. Intermediate-dose Ara-C plus G-CSF for stem cell mobilization in patients with lymphoid malignancies, including predicted poor mobilizers. Bone Marrow Transplant. 2013 Jul;48(7):915-21. doi: 10.1038/bmt.2012.269. Epub 2013 Jan 7. PMID 23292239