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Non-Hodgkin's LymphomaPhase 3NCT01767714

Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation

A Phase 3 study testing Granulocyte-colony stimulating factor (G-CSF) and Plerixafor in people with Non-Hodgkin's Lymphoma, run by Sanofi at 16 sites in China.

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

The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day [GRAN® only]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
Granulocyte-colony stimulating factor (G-CSF) and Plerixafor
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
16 sitesChina
Study dates
Apr 2013to Nov 2014
Phase
Phase 3
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a biopsy-confirmed diagnosis of NHL
  • Is 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
  • Treatment with an autologous peripheral HSC transplant is planned and the patient is eligible for autologous transplantation
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Has recovered from all acute toxic effects of prior chemotherapy or other cancer treatment.
  • Has an actual body weight <175% of their ideal body weight (IBW)
  • The patient agrees to use a highly effective method of contraception from Day 1 through ≥3 months following plerixafor treatment.

Who cannot join

  • Concurrent serious illness and pathological conditions
  • Has undergone previous HSC collections or collection attempt
  • Has had any autologous or allogeneic HSC transplant
  • Has active central nervous system (CNS) involvement
  • Bone marrow lymphoma cells involvement >20%, as assessed by bone marrow biopsy within 4 months before signing the ICF
  • Has received radiation therapy to the pelvis
Show all 16Show fewer
  • Has a diagnosis of all leukemias including any type of CLL
  • Active infection
  • Pregnant or nursing
  • Anticipated post-transplant chemotherapy and/or radiation therapy below the diaphragm
  • Received any prior radio-immunotherapy
  • Prior 1,3-bis(2-chloroethyl)-1-nitroso-urea (BCNU) within 6 weeks prior to first dose of G-CSF
  • Prior cancer therapy, other investigational therapy within 4 weeks prior to first dose of G-CSF
  • Prior granulocyte/macrophage-colony stimulating factor (GM-CSF) or pegfilgrastim within 3 weeks prior to the first dose of G-CSF
  • Prior G-CSF within 2 weeks prior to the first dose of G-CSF
  • Inadequate organ funtion evidenced by unacceptable laboratory result

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Investigational Site Number 156017

    Beijing, 100034

  • Investigational Site Number 156001

    Beijing, 100044

  • Investigational Site Number 156005

    Beijing, 100071

  • Investigational Site Number 156002

    Beijing, 100142

  • Investigational Site Number 156003

    Beijing, 100730

  • Investigational Site Number 156020

    Chongqing, 400037

  • Investigational Site Number 156016

    Fuzhou, 350001

  • Investigational Site Number 156021

    Guangzhou, 510060

  • Investigational Site Number 156011

    Hangzhou, 310003

  • Investigational Site Number 156018

    Nanjing, 210029

  • Investigational Site Number 156009

    Shanghai, 200025

  • Investigational Site Number 156010

    Suzhou, 215006

  • Investigational Site Number 156008

    Tianjin, 300020

  • Investigational Site Number 156013

    Wuhan, 430022

  • Investigational Site Number 156015

    Xi'an, 710038

  • Investigational Site Number 156022

    Zhengzhou, 450008

Other trials in China

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of Plerixafor (0.24 mg/kg) Plus G CSF (10 µg/kg) Versus G CSF (10 µg/kg) Plus Placebo to Mobilize and Collect ≥5 × 106 CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation

The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day [GRAN® only]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo.

Read the detailed description

Eligible patients who are unable to achieve adequate apheresis cell counts may enter an Open-Label Rescue Period where they will receive plerixafor, following the same study schedule as during the Double-Blind Treatment Period.

Being tested
Granulocyte-colony stimulating factor (G-CSF), Plerixafor, Placebo
Keywords
hematopoietic stem cell transplantation
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • Granulocyte-colony stimulating factor (G-CSF)Drug

    Also called GRAN®, Filgrastim

    10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection

  • PlerixaforDrug

    Also called Mozobil, AMD3100, GZ316455

    0.24 mg/kg/day subcutaneous injection

  • PlaceboDrug

    0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection

Study groups in NCT01767714
Study groupRoleWhat they receive
G-CSF + plerixaforExperimentalPatients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive plerixafor in the evening up to a maximum of 4 doses.
Receives: Drug: Granulocyte-colony stimulating factor (G-CSF); Drug: Plerixafor
G-CSF + PlaceboPlacebo comparatorPatients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive placebo in the evening up to a maximum of 4 doses.
Receives: Drug: Granulocyte-colony stimulating factor (G-CSF); Drug: Placebo

What is being measured

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

  1. Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis

    Measured: Days 5- Day8

Secondary outcomes (17)

  1. Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis

    Measured: Day 5 - Day 8

  2. Number of days of apheresis to collect ≥2 × 10^6 CD34+ cells/kg

    Measured: Up to achieve the target of collecting ≥2 × 10^6 CD34+ cells/kg

  3. Number of days of apheresis to collect ≥5 × 10^6 CD34+ cells/kg

    Measured: Up to achieve the target of collecting ≥5 × 10^6 CD34+ cells/kg

  4. Total number of CD34+ cells collected

    Measured: Day 5 - Day 8

  5. Time from transplantation to neutrophil and platelet (PLT) engraftment

    Measured: up to 30 days post-transplantation

  6. Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Measured: from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed

  7. Maximum plasma concentration (Cmax)

    Measured: Day 4 - Day 5

  8. Time to reach Cmax (Tmax)

    Measured: Day 4 - Day 5

  9. Area Under the Curve 0 to 10 hours post-dose (AUC0-10)

    Measured: Day 4 - Day 5

  10. Area Under the Curve 0 to last observed concentration (AUClast)

    Measured: Day 4 - Day 5

  11. Area Under the Curve (AUC)

    Measured: Day 4 - Day 5

  12. Percentage of extrapolation of AUC (AUCext)

    Measured: Day 4 - Day 5

  13. Half life (T1/2)

    Measured: Day 4 - Day 5

  14. Volume of distribution (Vz/F)

    Measured: Day 4 - Day 5

  15. Total body clearance (CL/F)

    Measured: Day 4 - Day 5

  16. Peripheral blood CD34+ cell counts (Pharmacodynamic analysis)

    Measured: Day 4 - Day 5

  17. The fold-increase in the number of circulating CD34+ following the first dose of plerixafor or placebo, with the first apheresis day (Day 5) value serving as the primary estimate

    Measured: Day 5 - Day 8

Timeline

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

  1. First posted14 Jan 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2014
  4. Study completionNov 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01767714
Sponsor's protocol ID
EFC12482
Other IDs
MOZ14409, U1111-1131-0145
Status last verified
Dec 2014
First submitted
17 Dec 2012
Last updated
9 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Granulocyte-colony stimulating factor (G-CSF) and Plerixafor in people with Non-Hodgkin's Lymphoma, run by Sanofi at 16 sites in China.

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 7 inclusion and 16 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 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis (time frame: Days 5- Day8). 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 NCT01767714.

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 9 Dec 2014.

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