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A Phase 4, Multicenter, Randomized, Comparator Trial Evaluating the Standard Weight-Based Dose (240 µg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination With G-CSF to Mobilize and Collect =5 x 106 CD34+ Cells/kg in =4 Days a

Phase 4
18 Years
78 Years
Not Enrolling
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Phase 4, Multicenter, Randomized, Comparator Trial Evaluating the Standard Weight-Based Dose (240 µg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination With G-CSF to Mobilize and Collect =5 x 106 CD34+ Cells/kg in =4 Days a

Inclusion Criteria:

- Patients diagnosed with NHL who are eligible to receive treatment with autologous
peripheral stem cell transplant for the first time

- Biopsy-confirmed diagnosis of NHL

- Weight ≤ 70kg

- 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

- At least 4 weeks since last cycle of chemotherapy and/or other cancer therapy
including rituximab

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Recovered from all acute toxic effects of prior chemotherapy

- Negative for human immunodeficiency virus (HIV), active hepatitis B, and active
hepatitis C from assessments performed within 3 months before signing informed

- Signed informed consent (ICF)

- White blood cell (WBC) count >2.5 × 10^9/L

- Absolute neutrophil count (ANC) >1.5 × 10^9/L

- Platelet (PLT) count >100 × 10^9/L

- Creatinine clearance ≥80 mL/min (estimated by Cockcroft-Gault formula or 24 hour
urine collection)

- Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT), serum
glutamic pyruvic transaminase/alanine aminotransferase (SGPT), and total bilirubin
<2.5 × upper limit of normal

- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation

Exclusion Criteria:

- A co-morbid condition which, in the view of the Investigator(s), renders the patient
at high risk from treatment complications

- Failed previous hematopoietic stem cell(HSC) collections or collection attempts

- Prior autologous or allogeneic transplant

- Less than 6 weeks off 1,3-bis(2-chloroethyl)-1-nitroso-urea (BCNU) prior to first
dose of G CSF

- Active central nervous system involvement, active brain metastases, or any history of
carcinomatous meningitis (active or inactive)

- Bone marrow involvement >20%, as assessed by bone marrow biopsy within 4 months of
the first Screening assessment, unless a bone marrow biopsy was performed immediately
prior to the last chemotherapy and was negative and the patient responded to last
chemotherapy achieving a complete or partial remission

- Received radiation therapy to the pelvis

- Received granulocyte/macrophage-colony stimulating factor (GM CSF) or pegfilgrastim
within 3 weeks prior to the first dose of granulocyte colony stimulating factor (G
CSF) for mobilization

- Received G CSF within 14 days prior to the first dose of G CSF for mobilization.

- Received prior radio-immunotherapy with ibritumomab tiuxetan or tositumomab iodine

- Active infection, including unexplained fever (>38.1 °C / 100.4 °F), or antibiotic,
antiviral, or antifungal therapy within 7 days prior to the first dose of G-CSF

- Positive pregnancy test (female patients)

- Lactating (female patients)

- Abnormal electrocardiogram (ECG) with clinically significant rhythm disturbance
(ventricular arrhythmias) or other conduction abnormality in the last year that, in
the opinion of the Investigator(s), warrants exclusion of the patient from the trial

- Previously received experimental therapy within 4 weeks of enrolling or who are
currently enrolled in another experimental protocol during the G CSF and plerixafor
treatment period

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients in each treatment arm who meet the target of ≥5 × 10^6 CD34+ cells/kg

Outcome Time Frame:

Variable between Day 5 and Day 8 of the Apheresis/Treatment Period

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

February 2013

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Arizona Cancer CenterTucson, Arizona  85724
University of Colorado Cancer CenterDenver, Colorado  80262
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Loyola University Medical CenterMaywood, Illinois  60153
University of Rochester Medical CenterRochester, New York  14642
City of Hope National Medical CenterLos Angeles, California  91010
Indiana Blood and Marrow TransplantationIndianapolis, Indiana  46202
Colorado Blood Cancer InstituteDenver, Colorado  80218