Phase 2
N=22
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
Hodgkin's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00396201 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF — 0.68; 0.32 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- G-CSF Plus Plerixafor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genzyme, a Sanofi Company
- Primary completion
- Oct 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF |
0.68; 0.32 | — |
| SECONDARY Overall Participant Counts of Adverse Events During the Treatment Period |
17; 5; 11; 1; 0; 2 | — |
| SECONDARY Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF |
0.95; 0.05 | — |
| SECONDARY Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL |
3.2 | — |
| SECONDARY Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg |
7; 6; 2 | — |
| SECONDARY Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment |
9.0 | — |
| SECONDARY Number of Days Post Transplantation to Platelet (PLT) Engraftment |
19.0 | — |
| SECONDARY Number of Participants With a Durable Graft at 12 Months |
21 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor |
831 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor |
0.6 | — |
| SECONDARY Half-life (T1/2) Following a Single Dose of Plerixafor |
3.5 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor |
3572 | — |
| SECONDARY Apparent Clearance (CL/F) of Single-dose Plerixafor |
5138 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor |
25464 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00396201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.