Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221492
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:

Primary Objective:

To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in 4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.

Secondary Objectives:

  • To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL participants.
  • To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
  • To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 5 x 10^6 CD34+ cells/kg.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: plerixafor GZ316455 Drug: Filgrastim Phase 2

Detailed Description:
Total study duration for a participant can be approximately up to 68 days.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Two-arm Parallel Group, Comparative Study for Assessing the Clinical Benefit of Subcutaneous Injection of Plerixafor Plus G-CSF for Mobilization and Collection of Peripheral Hematopoietic Stem Cells in Japanese Patients With Non-Hodgkin Lymphoma
Study Start Date : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Active Comparator: granulocyte colony-stimulating factor alone
G-CSF administered up to 8 days
Drug: Filgrastim
Pharmaceutical form:vial Route of administration: subcutaneous injection

Experimental: granulocyte colony-stimulating factor plus plerixafor
G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)
Drug: plerixafor GZ316455
Pharmaceutical form:vial Route of administration: subcutaneous injection
Other Name: Mozobil

Drug: Filgrastim
Pharmaceutical form:vial Route of administration: subcutaneous injection




Primary Outcome Measures :
  1. Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis [ Time Frame: Day 5 to Day 8 of the apheresis/treatment period ]

Secondary Outcome Measures :
  1. Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis [ Time Frame: Day 5 to Day 8 of the apheresis/treatment period ]
  2. Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells [ Time Frame: Day 5 to Day 8 of the apheresis/treatment period ]
  3. Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells [ Time Frame: Day 5 to Day 8 of the apheresis/treatment period ]
  4. Total number of CD34+ cells/kg collected over up to 4 apheresis [ Time Frame: Day 5 to Day 8 of the apheresis/treatment period ]
  5. The relative increase (ratio) of peripheral blood (PB) CD34+ cell count (cells/μL) [ Time Frame: From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only ]
  6. Number of participants with adverse events [ Time Frame: Up to 68 days ]
  7. Change from baseline in clinical laboratory measurements [ Time Frame: Up to 68 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 20 to 75.
  • Japanese participants with histological or pathological diagnosis of NHL.
  • First or second complete response (CR) or partial response (PR).

Exclusion criteria:

  • Leukemia participants.
  • Myelodysplastic syndrome (MDS) participants.
  • Less than 2 weeks since completion of last cycle of chemotherapy.
  • Failed previous hematopoietic stem cell (HSC) collections or collection attempts.
  • Prior autologous or allogeneic transplant.
  • Diagnosis of another malignancy.
  • Known hypersensitivity to plerixafor, G-CSF or their components.
  • Bone marrow involvement greater than 5%.
  • Eastern Cooperative Oncology Group (ECOG) performance status greater than 1.
  • Not yet recovered from all acute toxic effects of prior Chemotherapy.
  • White blood cell (WBC) count less than or equal to 2.5 × 10^9 cells/L.
  • Absolute neutrophil count (ANC) less than or equal to 1.5 × 10^9 cells /L.
  • Platelet count less than or equal to 100 × 10^9 cells /L.
  • Creatinine clearance less than 50 mL/min.
  • Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) greater than or equal to 2.5 x upper limit of normal,Total Bilirubin greater than or equal to 2.5 x upper limit of normal.
  • Cardiac and pulmonary status insufficient to undergo apheresis or transplantation.
  • Active central nervous system (CNS) involvement, active brain metastases, or any history of carcinomatous meningitis.
  • Active infection, including unexplained fever (greater than 38 degrees C), or antibiotic therapy within 7 days prior to the first dose of G-CSF.
  • Less than 6 weeks off nitrosoureas prior to first dose of G-CSF.
  • Conditions/situations such as received prior radio-immunotherapy with ibritumomab tiuxetan or tositumomab iodine and received radiation therapy to the pelvis.
  • Significant concomitant illness, including psychiatric condition that, in the opinion of the Investigator or Sponsor, would adversely affect the participant's participation in the study.
  • 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 participant from the trial.
  • Previously received experimental therapy within 4 weeks of randomization or who are currently enrolled in another experimental protocol during the G-CSF and plerixafor treatment period.
  • Any malignancy related to immunodeficiency virus (HIV) or solid organ transplant; history of known HIV, viral hepatitis as documented at the detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb)[exclude patients who clearly received vaccination], hepatitis B core antibody (HBcAb), and/or hepatitis C virus (HCV) antibody at the time of the screening visit.
  • Unwillingness and inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
  • Related to the active comparator and/or mandatory background therapies.
  • Received G-CSF within 7 days prior to the first dose of G-CSF for mobilization.
  • Related to the current knowledge of Sanofi compound.
  • Pregnant or breast-feeding women.
  • All participants, who are sexually active (males and females), must agree to an effective method of contraception while on study treatment and for at least 3 months following plerixafor treatment (including both female participants of child-bearing potential and male participants with partners of childbearing potential).
  • Patient who has withdrawn consent before enrollment/randomization.
  • Despite screening of the patient, enrollment/randomization is stopped at the study level.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221492


Locations
Layout table for location information
Japan
Investigational Site Number 392005
Chiba-Shi, Japan
Investigational Site Number 392011
Fukuoka-Shi, Japan
Investigational Site Number 392014
Fukuyama-Shi, Japan
Investigational Site Number 392010
Hamamatsu-Shi, Japan
Investigational Site Number 392006
Kamogawa-Shi, Japan
Investigational Site Number 392003
Kobe-Shi, Japan
Investigational Site Number 392008
Kurashiki-Shi, Japan
Investigational Site Number 392015
Ota-Shi, Japan
Investigational Site Number 392004
Sapporo-Shi, Japan
Investigational Site Number 392001
Shibuya-Ku, Japan
Investigational Site Number 392009
Suwa-Shi, Japan
Investigational Site Number 392007
Toyohashi-Shi, Japan
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02221492     History of Changes
Other Study ID Numbers: ACT12781
U1111-1152-4309 ( Other Identifier: UTN )
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Plerixafor octahydrochloride
Lenograstim
Sargramostim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents