Clinical trial · Interventional
Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of Plerixafor (0.24 mg/kg) Plus G CSF (10 µg/kg) Versus G CSF (10 µg/kg) Plus Placebo to Mobilize and Collect ≥5 × 106 CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
NCT01767714CI-TRIAL-00016306completedPhase 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 study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day \[GRAN® only\]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo.
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's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granulocyte-colony stimulating factor (G-CSF) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- G-CSF + plerixafor
- description
- Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive plerixafor in the evening up to a maximum of 4 doses.
- interventionNames
- Drug: Granulocyte-colony stimulating factor (G-CSF)
- Drug: Plerixafor
- type
- PLACEBO_COMPARATOR
- label
- G-CSF + Placebo
- description
- Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive placebo in the evening up to a maximum of 4 doses.
- interventionNames
- Drug: Granulocyte-colony stimulating factor (G-CSF)
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Has a biopsy-confirmed diagnosis of NHL * Is in first or second complete remission or partial remission, defined for the purpose of this study as complete or partial response following first- or second-line therapy * Treatment with an autologous peripheral HSC transplant is planned and the patient is eligible for autologous transplantation * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Has recovered from all acute toxic effects of prior chemotherapy or other cancer treatment. * Has an actual body weight \<175% of their ideal body weight (IBW) * The patient agrees to use a highly effective method of contraception from Day 1 through ≥3 months following plerixafor treatment. Exclusion Criteria: * Concurrent serious illness and pathological conditions * Has undergone previous HSC collections or collection attempt * Has had any autologous or allogeneic HSC transplant * Has active central nervous system (CNS) involvement * Bone marrow lymphoma cells involvement \>20%, as assessed by bone marrow biopsy within 4 months before signing the ICF * Has received radiation therapy to the pelvis * Has a diagnosis of all leukemias including any type of CLL * Active infection * Pregnant or nursing * Anticipated post-transplant chemotherapy and/or radiation therapy below the diaphragm * Received any prior radio-immunotherapy * Prior 1,3-bis(2-chloroethyl)-1-nitroso-urea (BCNU) within 6 weeks prior to first dose of G-CSF * Prior cancer therapy, other investigational therapy within 4 weeks prior to first dose of G-CSF * Prior granulocyte/macrophage-colony stimulating factor (GM-CSF) or pegfilgrastim within 3 weeks prior to the first dose of G-CSF * Prior G-CSF within 2 weeks prior to the first dose of G-CSF * Inadequate organ funtion evidenced by unacceptable laboratory result
References
Publications (0)
Data not yet available
No reference posted for this study.