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Completed

NCT Number: NCT01164475

Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 Kilograms

The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.

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Key information

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Princess Margaret Hospital, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 78 years (inclusive)
  • Patients diagnosed with NHL who were to receive treatment with an autologous peripheral stem cell transplant for the first time
  • Biopsy-confirmed diagnosis of NHL (chronic lymphocytic leukemia and all variants were excluded)
  • Weight less than or equal to 70 kg
  • 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 only
  • 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 consent
  • Signed informed consent form (ICF)
  • White blood cell count (WBC) greater than (>) 2.5*10^9 per liter (L)
  • Absolute neutrophil count (ANC) >1.5*10^9/L
  • Platelet (PLT) count >100*10^9/L
  • Creatinine clearance >=80 milliliter per minute (mL/min) (estimated by Cockcroft-Gault formula or 24 hour urine collection)
  • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT), and total bilirubin less than 2.5*upper limit of normal
  • Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
  • All patients agreed to an effective method of contraception while on study treatment and for at least 3 months following plerixafor treatment (including both female patients of child-bearing potential and male patients with partners of child-bearing potential)

Exclusion criteria

  • A co-morbid condition which, in the view of the Investigator(s), rendered 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 percent (%), 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 degree Celsius / 100.4 Fahrenheit), 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), warranted exclusion of the patient from the trial
  • Previously received experimental therapy within 4 weeks of enrolling or who were currently enrolled in another experimental protocol during the G CSF and plerixafor treatment period

Treatment and study plan

Granulocyte-colony stimulating factor (G-CSF)

Drug

Other names: Filgrastim

Fixed Dose Plerixafor

Drug

Other names: Mozobil, AMD3100

Weight-Based Plerixafor

Drug

Other names: Mozobil, AMD3100

Primary outcomes

  1. Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)

    Time frame: Day 5 up to Day 8

    The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >=5*10^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.

  2. Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])

    Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5

Secondary outcomes

  1. Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis

    Time frame: Day 5 up to Day 8

    The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >= 2*10^6 CD34+ cells/kg (minimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.

  2. Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg

    Time frame: Day 5 up to Day 8

  3. Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg

    Time frame: Day 5 up to Day 8

  4. Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses

    Time frame: Day 5 up to Day 8

    The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was reported.

  5. Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor

    Time frame: Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)

    Fold increase was calculated as CD34+ cell count on Day 5 divided by CD34+ cell count on Day 4.

  6. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5

  7. Time to Reach Maximum Plasma Concentration (Tmax)

    Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5

  8. Terminal Elimination Half-life (T1/2)

    Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5

    T1/2 is the time required for the plasma concentration to decrease to one half.

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Phase 4, Multicenter, Randomized, Comparator Trial Evaluating the Standard Weight-Based Dose (0.24 mg/kg) Compared to a Fixed Dose (20 mg) of Plerixafor Injection in Combination With G-CSF to Mobilize and Collect ≥5 x 10^6 CD34+ Cells/kg in ≤4 Days and to Evaluate the Difference in Total Systemic Exposure in Patients With Non-Hodgkin's Lymphoma Weighing ≤70 kg

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 16, 2010
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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