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
Condition: Hodgkin's Disease
MeSH terms: Hodgkin Disease
Intervention: G-CSF Plus Plerixafor
Intervention description: Randomized participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hodgkin's Disease; Stem cell mobilization; apheresis

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 <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