Clinical trial · Interventional
AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease
Treatment With AMD3100 Added to a Mobilizing Regimen of G-CSF to Increase the Number of Peripheral Blood Stem Cells in Patients With Hodgkin's Disease
- 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)
Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic (PK) study. The only changes to the standard of care is the addition of plerixafor to a granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to apheresis. The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34+ stem cells (≥5\*10\^6 cells/kg) after hematopoietic stem cell mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.
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 |
|---|---|---|---|
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G-CSF Plus Plerixafor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Hodgkin's Disease (HD)
- description
- Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation.
- interventionNames
- Drug: G-CSF Plus Plerixafor
Primary outcomes (1)
- measure
- Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
- timeFrame
- Day 5 up to Day 9
- description
- The proportion of total participants who mobilized ≥5\*10\^6 CD34+ cells/kg based on data from local laboratories.
Secondary outcomes (13)
- measure
- Overall Participant Counts of Adverse Events During the Treatment Period
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of HD eligible for autologous transplantation * No more than 3 prior regimens of chemotherapy (Rituximab is not considered chemotherapy for the purpose of this study.) * 4 weeks since last cycle of chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * The patient has recovered from all acute toxic effects of prior chemotherapy * White blood cell count (WBC) \>3.0\*10\^9/L * Absolute polymorphonuclear cells (PMN) count \>1.5\*10\^9/L * Platelet (PLT) count \>100\*10\^9/L * Serum creatinine ≤2.2 mg/DL * Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<2 x upper limit of normal (ULN) * Left ventricle ejection fraction \>45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan * Forced expiratory volume of the lung in the first second (FEV1) \>60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) \>45% of predicted * Negative for human immunodeficiency virus (HIV) Exclusion Criteria: * A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications * Patients who have failed previous collections * A residual acute medical condition resulting from prior chemotherapy * Hodgkin's disease involving the central nervous system * Acute infection * Fever (temp \>38°C/100.4°F) * Patients whose actual body weight exceeds 150% of their ideal body weight * History of ventricular arrhythmias * History of paresthesias * Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period
References
Publications (1)
- BACKGROUNDCashen A, Lopez S, Gao F, Calandra G, MacFarland R, Badel K, DiPersio J. A phase II study of plerixafor (AMD3100) plus G-CSF for autologous hematopoietic progenitor cell mobilization in patients with Hodgkin lymphoma. Biol Blood Marrow Transplant. 2008 Nov;14(11):1253-61. doi: 10.1016/j.bbmt.2008.08.011. PMID 18940680