NCT02221492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

August 19, 2014

Last Update Submit

March 29, 2016

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (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

    Day 5 to Day 8 of the apheresis/treatment period

Secondary Outcomes (7)

  • 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

    Day 5 to Day 8 of the apheresis/treatment period

  • Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells

    Day 5 to Day 8 of the apheresis/treatment period

  • Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells

    Day 5 to Day 8 of the apheresis/treatment period

  • Total number of CD34+ cells/kg collected over up to 4 apheresis

    Day 5 to Day 8 of the apheresis/treatment period

  • The relative increase (ratio) of peripheral blood (PB) CD34+ cell count (cells/μL)

    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

  • +2 more secondary outcomes

Study Arms (2)

granulocyte colony-stimulating factor alone

ACTIVE COMPARATOR

G-CSF administered up to 8 days

Drug: Filgrastim

granulocyte colony-stimulating factor plus plerixafor

EXPERIMENTAL

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 GZ316455Drug: Filgrastim

Interventions

plerixafor GZ316455DRUG

Pharmaceutical form:vial Route of administration: subcutaneous injection

Also known as: Mozobil
granulocyte colony-stimulating factor plus plerixafor
FilgrastimDRUG

Pharmaceutical form:vial Route of administration: subcutaneous injection

granulocyte colony-stimulating factor alonegranulocyte colony-stimulating factor plus plerixafor

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Investigational Site Number 392005

Chiba, Japan

Location

Investigational Site Number 392011

Fukuoka, Japan

Location

Investigational Site Number 392014

Fukuyama-Shi, Japan

Location

Investigational Site Number 392010

Hamamatsu, Japan

Location

Investigational Site Number 392006

Kamogawa-Shi, Japan

Location

Investigational Site Number 392003

Kobe, Japan

Location

Investigational Site Number 392008

Kurashiki-Shi, Japan

Location

Investigational Site Number 392015

Ota-Shi, Japan

Location

Investigational Site Number 392004

Sapporo, Japan

Location

Investigational Site Number 392001

Shibuya-Ku, Japan

Location

Investigational Site Number 392009

Suwa-Shi, Japan

Location

Investigational Site Number 392007

Toyohashi, Japan

Location

Related Publications (1)

  • Matsue K, Kumagai K, Sugiura I, Ishikawa T, Igarashi T, Sato T, Uchiyama M, Miyamoto T, Ono T, Ueda Y, Kiguchi T, Sunaga Y, Sasaki T, Suzuki K. Plerixafor for mobilization and collection of haematopoietic stem cells for autologous transplantation in Japanese patients with non-Hodgkin lymphoma: a randomized phase 2 study. Int J Hematol. 2018 Nov;108(5):524-534. doi: 10.1007/s12185-018-2505-4. Epub 2018 Jul 24. Erratum In: Int J Hematol. 2018 Nov;108(5):564. doi: 10.1007/s12185-018-2524-1.

    PMID: 30043330DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

plerixaforFilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 20, 2014

Study Start

November 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

JP(12)