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LymphomaPhase 2NCT02221492

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

A Phase 2 study testing plerixafor GZ316455 and Filgrastim in people with Lymphoma, run by Genzyme, a Sanofi Company at 12 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Lymphoma
What is being tested?
plerixafor GZ316455 and Filgrastim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
12 sitesJapan
Study dates
Nov 2014to Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 33Show fewer
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Investigational Site Number 392005

    Chiba

  • Investigational Site Number 392011

    Fukuoka

  • Investigational Site Number 392014

    Fukuyama-Shi

  • Investigational Site Number 392010

    Hamamatsu

  • Investigational Site Number 392006

    Kamogawa-Shi

  • Investigational Site Number 392003

    Kobe

  • Investigational Site Number 392008

    Kurashiki-Shi

  • Investigational Site Number 392015

    Ota-Shi

  • Investigational Site Number 392004

    Sapporo

  • Investigational Site Number 392001

    Shibuya-Ku

  • Investigational Site Number 392009

    Suwa-Shi

  • Investigational Site Number 392007

    Toyohashi

Other trials in Japan

About this study

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

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.

Read more

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.
Read the detailed description

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

Conditions
Lymphoma
Being tested
plerixafor GZ316455, Filgrastim
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • plerixafor GZ316455Drug

    Also called Mozobil

    Pharmaceutical form:vial Route of administration: subcutaneous injection

  • FilgrastimDrug

    Pharmaceutical form:vial Route of administration: subcutaneous injection

Study groups in NCT02221492
Study groupRoleWhat they receive
granulocyte colony-stimulating factor aloneActive comparatorG-CSF administered up to 8 days
Receives: Drug: Filgrastim
granulocyte colony-stimulating factor plus plerixaforExperimentalG-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)
Receives: Drug: plerixafor GZ316455; Drug: Filgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 5 to Day 8 of the apheresis/treatment period

Secondary outcomes (7)

  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

    Measured: 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

    Measured: 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

    Measured: Day 5 to Day 8 of the apheresis/treatment period

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

    Measured: Day 5 to Day 8 of the apheresis/treatment period

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

    Measured: 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

    Measured: Up to 68 days

  7. Change from baseline in clinical laboratory measurements

    Measured: Up to 68 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02221492
Sponsor's protocol ID
ACT12781
Other IDs
U1111-1152-4309
Status last verified
Mar 2016
First submitted
19 Aug 2014
Last updated
30 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30043330

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing plerixafor GZ316455 and Filgrastim in people with Lymphoma, run by Genzyme, a Sanofi Company at 12 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02221492, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016; AzTrials last refreshed its copy on 1 Nov 2026.

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