Clinical trial · Interventional
Lymphocyte Reconstitution After Administration of Pegfilgrastim Versus Filgrastim After Peripheral Stem Cell Transplantation
Lymphocyte Reconstitution in a Randomized Study After Administration of Pegfilgrastim Versus Filgrastim in Patients With B-cell Non-Hodgkin Lymphoma Treated With High-dose Chemotherapy and Autologous Peripheral Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Number of enrolled patients was insufficient during planned inclusion time.
Summary
Brief summary (as posted)
The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral stem cell transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Filgrastim | Drug | Filgrastim | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pegfilgrastim
- interventionNames
- Drug: Pegfilgrastim
- type
- ACTIVE_COMPARATOR
- label
- Filgrastim
- interventionNames
- Drug: Filgrastim
Primary outcomes (1)
- measure
- 3 months kinetics of lymphocyte reconstitution, in the two arms
- timeFrame
- Lymphocyte count within the 3 months post transplantation
Secondary outcomes (10)
- measure
- 6 months kinetics of lymphocyte reconstitution, in the two arms
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Patients with B-cell NHL, except Burkitt Lymphoma and primary brain lymphoma, as first-line or second-line therapy, with planed BICNU, etoposide, aracytine and melphalan (BEAM) chemotherapy after pre-inclusion. * Minimum one mobilization with G-CSF, G-CSF and endoxan or mozobil * Minimum one cytapheresis with CD34\>2 millions CD34/kg for stem cell transplantation * Patients hospitalized in the investigational center throughout the procedure and until recovery from aplasia (neutrophils\> 0.5 G/L) * Mandatory affiliation with a health insurance system * Subjects must provide written informed consent prior to performance of study-specific assessments Exclusion Criteria: * Patients already treated with intensive chemotherapy and autologous stem cell transplantation * Total irradiation exposure (patients with partial irradiation exposure can be included in the study) * Intolerance to one of the two studied growth factors, or hypersensitivity to one of their components * Patients with neutropenia (neutrophils \<1.2 G/L) or thrombopenia (platelets \< 100 G/L) before intensive chemotherapy * Acquired immune deficiency syndrome, seropositivity * Pregnant or lactating women (pregnancy test, for women of childbearing potential, should be negative, in blood or urine, at inclusion time) * Impossibility to comply with protocol constraints because of geographical, psychiatric, social or family reasons * Deprived of liberty (court judgement or administrative decision)
References
Publications (20)
- BACKGROUNDDieckmann D, Plottner H, Berchtold S, Berger T, Schuler G. Ex vivo isolation and characterization of CD4(+)CD25(+) T cells with regulatory properties from human blood. J Exp Med. 2001 Jun 4;193(11):1303-10. doi: 10.1084/jem.193.11.1303. PMID 11390437
- BACKGROUNDGoguel AF, Crainic K, Ducailar A, Ouin M. Interlaboratory quality assessment of lymphocyte phenotyping. Etalonorme 1990-1992 surveys. Biol Cell. 1993;78(1-2):79-84. doi: 10.1016/0248-4900(93)90118-x. PMID 8220229
- BACKGROUNDHolmes FA, Jones SE, O'Shaughnessy J, Vukelja S, George T, Savin M, Richards D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002 Jun;13(6):903-9. doi: 10.1093/annonc/mdf130. PMID 12123336
- BACKGROUNDHolmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727. PMID 11821454
- BACKGROUNDJoao C, Porrata LF, Inwards DJ, Ansell SM, Micallef IN, Johnston PB, Gastineau DA, Markovic SN. Early lymphocyte recovery after autologous stem cell transplantation predicts superior survival in mantle-cell lymphoma. Bone Marrow Transplant. 2006 May;37(9):865-71. doi: 10.1038/sj.bmt.1705342. PMID 16532015
- BACKGROUNDJonuleit H, Schmitt E, Stassen M, Tuettenberg A, Knop J, Enk AH. Identification and functional characterization of human CD4(+)CD25(+) T cells with regulatory properties isolated from peripheral blood. J Exp Med. 2001 Jun 4;193(11):1285-94. doi: 10.1084/jem.193.11.1285.