Clinical trial · Interventional
Mozobil for Autologous Stem Cell Mobilization
Plerixafor (Plerixafor AMD 3100) + Recombinant Human G-CSF (rhG-CSF) for Autologous Peripheral Blood Stem Cell Transplantation (AutoSCT) in Hard to Mobilise Patients: a Phase IIB Study
NCT01164345CI-TRIAL-00020045completedPhase 2ClinicalTrials.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 aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL) patients for autologous transplantation.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autologous Stem Cell Transplantation | — | UNRESOLVED | — |
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Stem Cell Mobilization | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MOZOBIL
- description
- treatment with mozobil for autologous stem cell collection
- interventionNames
- Drug: Plerixafor
Primary outcomes (1)
- measure
- Mobilisation success rate
- timeFrame
- 4 weeks
- description
- Mobilisation success rate is defined as the mobilisation of a PBSC graft containing \>2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach \>2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching \>5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.
Secondary outcomes (1)
- measure
- engraftment after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Patients eligible and planned for an autologous haematopoietic stem cell transplantation. 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 1.2 WBC count ≥2.5x109/L. 1.3 Absolute neutrophil count ≥1.5x109/L. 1.4 Platelet count ≥100x109/L 1.5 Adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation. 1.6 Previously, heavily pretreated lymphoma patients or patients suspected to have a poor bone marrow stem cell reserve for at least one of the following: * \>2 lines of chemotherapy. * Previous radiotherapy involving bone marrow * Prior therapy with specific stem cell toxic chemotherapeutic agents * Platelets count pre-mobilisation, ≤150.103 x mm3 * Level of circulating CD34+ ≤ 20 cells/mcL prior to apheresis on the collection day * Patients \> 60 years of age Exclusion Criteria: 2.1 Lymphoma patients that did not fulfil the inclusion criteria. 2.2 History of any acute or chronic leukemia (including myelodysplastic syndrome. 2.3 Prior allogeneic or autologous transplantation. 2.4 Inability to tolerate stem cell harvest. 2.5 Peripheral venous access not possible. 2.6 Pregnant or nursing women. 2.7 Positive serology for hepatitis B or C. 2.8 Acute infection (febrile, i.e. temperature \> 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF. 2.9 HIV positive. 2.10 Left ventricular ejection fraction \< 50%. 2.11 DLCO \< 50%. 2.12 Splenectomised or splenic irradiation. 2.13 Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study. 2.14 Treatment with other investigational drugs within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.
References
Publications (0)
Data not yet available
No reference posted for this study.