Phase 2 Completed N=100 Treatment

AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts

Autologous Stem Cell Transplantation

Source: ClinicalTrials.gov NCT00396331 ↗

Enrolled (actual)

100

Serious AEs

6.0%

Results posted

Dec 2010

Primary outcomePrimary: Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period — 65; 20; 9; 3 Participants

Summary

This study evaluates the safety, efficacy, and pharmacokinetics (PK) of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients who would benefit from an autologous stem cell transplant but have failed previous collections or collection attempts with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional therapy including cytokines, chemotherapy and cytokines and bone marrow harvests. The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of AMD3100 (plerixafor) on the evening prior to each day of apheresis. Efficacy outcomes include quantification of CD34+ cells in the apheresis product and assessment of successful polymorphonuclear leukocyte (PMN) and platelet (PLT) engraftment after transplantation. PK outcomes include analysis of repeated doses of plerixafor.

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period	65; 20; 9; 3; 97; 42	—
PRIMARY Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF	.773; .714; 1.00; .667; .780	—
PRIMARY Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF	0.288; 0.429; 0.70; 0.667; 0.37	—
SECONDARY Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment	12.0; 12.0; 13.0; 10.0; 12.0	—
SECONDARY Median Number of Days to Platelet (PLT) Engraftment	21.0; 21.0; 19.0; 26.0; 21.0	—
SECONDARY Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation	44; 14; 7; 65	—
SECONDARY Number of Participants With Non-Hodgkin's Lymphoma (NHL) Who Had Evidence of Tumor Cell Mobilization After G-CSF or Plerixafor Administration	—	—
SECONDARY Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF	54; 18; 10; 2; 84	—
SECONDARY Number of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF	21; 9; 7; 2; 39	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) on Day 4	796	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) on Day 7	894	—
SECONDARY Time to Maximum Plasma Concentration (Tmax) on Day 4	0.500	—
SECONDARY Time to Maximum Plasma Concentration (Tmax) on Day 7	0.500	—
SECONDARY Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 4	4578	—
SECONDARY Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 7	5496	—

Eligibility Criteria

Inclusion Criteria

Eligible to undergo autologous transplantation
Has failed previous collections or collection attempts with a mobilization regimen of granulocyte colony-stimulating factor (G-CSF), chemotherapy and G-CSF or any other conventional therapy including cytokines, chemotherapy and cytokines or bone marrow harvest.
Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
≥3 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade™ are not considered prior chemotherapy for the purpose of this study) NOTE: Although thalidomide, dexamethasone, and Velcade™ are not considered prior chemotherapy for the purpose of this study, none are to be administered within 7 days prior to the first dose of G-CSF (see Exclusion Criteria).
The patient has recovered from all acute toxic effects of prior chemotherapy
White blood cell count (WBC) >2.5*10^9/L
Absolute neutrophil count >1.5*10^9/L
Platelet count >85*10^9/L
Serum creatinine ≤1.5 mg/dl
Creatinine clearance >60 ml/min
Aspartate aminotransferase (AST), alanine transaminase (ALT) and total bilirubin 45% (by normal echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan)
Forced expiratory volume in one minute (FEV1) >60% of predicted or diffusion lung capacity for carbon monoxide (DLCO) ≥45% of predicted
No active infection of hepatitis B or C
Negative for HIV
Signed informed consent
Women of child-bearing potential agree to use an approved form of contraception

Exclusion Criteria

Once 70 patients have enrolled, patients with diagnoses other than lymphoma are not eligible (eg, acute myeloid leukemia, chronic lymphocytic leukemia, or multiple myeloma).
A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
A residual acute medical condition resulting from prior chemotherapy
Received Neupogen™, thalidomide, dexamethasone, and/or Velcade™ within 7 days prior to the first dose of G-CSF
Brain metastases or carcinomatous meningitis
Acute infection
Fever (temperature >38°C/100.4°F)
Hypercalcaemia (>1 mg/dL above the ULN)
Positive pregnancy test in female patients
Lactating females
Patients of child-bearing potential unwilling to implement adequate birth control
Patients whose actual body weight exceeds 175% of their ideal body weight
Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the Mobilization phase

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Data sourced from ClinicalTrials.gov (NCT00396331). 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. Informational only — not medical advice.