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

NCT01164475 | Completed Phase 4 Results

• 2 other identifiers: MOZ11809MSC12830
• Study Type: interventional
• Target: 61
• Locations: 4 countries
• Sites: 7

Brief Summary

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.

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (2)

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

  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.

  Day 5 up to Day 8

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

  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 (8)

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

  Day 5 up to Day 8

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

  Day 5 up to Day 8

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

  Day 5 up to Day 8

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

  Day 5 up to Day 8

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

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

Study Arms (2)

Fixed Dose Plerixafor

EXPERIMENTAL

10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to \[\>=\] 5\*10\^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.

Drug: Granulocyte-colony stimulating factor (G-CSF); Drug: Fixed Dose Plerixafor

Weight-Based Plerixafor

ACTIVE COMPARATOR

G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (\>=5\*10\^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.

Drug: Granulocyte-colony stimulating factor (G-CSF); Drug: Weight-Based Plerixafor

Interventions

Granulocyte-colony stimulating factor (G-CSF) DRUG

Also known as: Filgrastim

Fixed Dose Plerixafor; Weight-Based Plerixafor

Fixed Dose Plerixafor DRUG

Also known as: Mozobil, AMD3100

Fixed Dose Plerixafor

Weight-Based Plerixafor DRUG

Also known as: Mozobil, AMD3100

Weight-Based Plerixafor

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (7)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

St. Mary's Hospital

Seoul, 137-701, South Korea

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim; plerixafor

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-us@sanofi.com

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 16, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 25, 2014
• Results First Posted: January 31, 2014

Record last verified: 2014-02

Locations

US (2); CA (1); TW (2); KR (2)