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Lymphoma, Non-HodgkinPhase 2NCT03244930

Low Dose Plerixafor Plus G-CSF in Mobilizing Stem Cells for Autologous Peripheral Blood Transplantation

A Phase 2 study testing Plerixafor 0.12 mg/kg in people with Lymphoma, Non-Hodgkin and Lymphoma, Hodgkin, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely administered once as a single dose in first attempt leading to apheresis yields of >2 x 106 CD34+ cells/kg body weight. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lymphoma, Non-Hodgkin, Lymphoma, Hodgkin, Myeloma
What is being tested?
Plerixafor 0.12 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteMexico
Study dates
10 May 2017to 10 Jun 2018
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Candidates planned for an autologous haematopoietic stem cell transplantation without previous mobilization attempts with chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • WBC count ≥2.5x109/L.
  • Absolute neutrophil count ≥1.5x109/L.
  • Platelet count ≥100x109/L

Who cannot join

  • Prior allogeneic or autologous transplantation.
  • Pregnant women.
  • Acute infection (febrile, i.e. temperature > 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF.
  • Positive serology for hepatitis B or C or HIV.
  • Left ventricular ejection fraction < 40%
  • AST ALT >2.5x or Creatinine >2 md/dL

Trial locations and contacts

1 site in 1 country.

Perla Colunga, MD contact

+528110761973

alrep_rcp@hotmail.com

Dalila Alvarado, MD contact

dalila_alvarado@hotmail.com

Mexico1 site, 1 recruiting

  • Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo Leon

    Monterrey, Nuevo León, 64460

    Perla Colunga Pedraza, MD, +528110761973, colunga.perla@gmail.com

    Guillermo Sotomayor Duque, MD

    Recruiting

Other trials in Mexico

About this study

Official title: Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation

Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely administered once as a single dose in first attempt leading to apheresis yields of >2 x 106 CD34+ cells/kg body weight.

Read the detailed description

Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. Consecutive patients in autologous transplant protocol will receive mobilization consisted of daily subcutaneously G-CSF 10 mg/kg for 4 days and plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of apheresis. HSC collection was performed with a Cobe Spectra® or Spectra Optia® apheresis system. The planned target blood volume to be processed will be 4-fold total blood volume calculated according to patients' weight and size. Peripheral blood CD34+ counts will be analyzed using flow cytometry. For each ASCT, we aimed for target yields of at least 2 x 106 CD34+cells/kg. Toxicities and engraftment will be documented.

Being tested
Plerixafor 0.12 mg/kg
Medical subject headings
Lymphoma, Non-Hodgkin, Hodgkin Disease, Neoplasms, Plasma Cell

What participants receive

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

  • Plerixafor 0.12 mg/kgDrug

    Also called mozobil

    Subcutaneously G-CSF 10 mg/kg for 4 days. At day four SC plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of aphaeresis.

Study groups in NCT03244930
Study groupRoleWhat they receive
Arm 1ExperimentalPlerixafor 0.12 mg/kg SC will be administered in the evening, 11 hours prior to initiation of apheresis. G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
Receives: Drug: Plerixafor 0.12 mg/kg

What is being measured

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

  1. Harvest of of at least 2 x106 CD34+/kg

    percentage of patients with a target yields of at least 2 x 106 CD34+ cells/kg in one single aphaeresis procedure.

    Measured: 5 days

Secondary outcomes (2)

  1. Time to engraftment

    Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl

    Measured: 100 days

  2. Rate of patients reaching a peripheral blood precount higher than 20 cells/μL

    Rate of patients reaching a peripheral blood precount higher than 20 cells/μL

    Measured: 5 days

Timeline

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

  1. First posted10 Aug 2017
  2. Study start10 May 2017
  3. Primary completion10 May 2018 (estimated)
  4. Study completion10 Jun 2018 (estimated)

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
Not applicable
Intervention model
Single group
Model description
Prospective, open-labeled, single-arm study
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03244930
Sponsor's protocol ID
HE17-00007
Status last verified
Aug 2017
First submitted
7 Aug 2017
Last updated
10 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31.

    PubMed 19720922

  • Flomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12.538. Epub 2010 Jan 11.

    PubMed 20067838

  • Brave M, Farrell A, Ching Lin S, Ocheltree T, Pope Miksinski S, Lee SL, Saber H, Fourie J, Tornoe C, Booth B, Yuan W, He K, Justice R, Pazdur R. FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. Oncology. 2010;78(3-4):282-8. doi: 10.1159/000315736. Epub 2010 Jun 8.

    PubMed 20530974

  • Haverkos BM, Huang Y, Elder P, O'Donnell L, Scholl D, Whittaker B, Vasu S, Penza S, Andritsos LA, Devine SM, Jaglowski SM. A single center's experience using four different front line mobilization strategies in lymphoma patients planned to undergo autologous hematopoietic cell transplantation. Bone Marrow Transplant. 2017 Apr;52(4):561-566. doi: 10.1038/bmt.2016.304. Epub 2017 Jan 9.

    PubMed 28067870

  • Gutierrez-Aguirre CH, Alvarado-Navarro DM, Palomares-Leal A, Mejia-Jaramillo G, Salazar-Riojas R, Leon AG, Colunga-Pedraza PR, Sotomayor-Duque G, Jaime-Perez JC, Cantu-Rodriguez OG, Del Carmen Tarin-Arzaga L, Flores-Jimenez JA, Gomez-Almaguer D. Reduced-dose plerixafor as a mobilization strategy in autologous hematopoietic cell transplantation: a proof of concept study. Transfusion. 2019 Dec;59(12):3721-3726. doi: 10.1111/trf.15547. Epub 2019 Oct 16.

    PubMed 31618456

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Plerixafor 0.12 mg/kg in people with Lymphoma, Non-Hodgkin and Lymphoma, Hodgkin, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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?

Results are not available in the source record.

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

Contact Perla Colunga, MD (+528110761973, alrep_rcp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Harvest of of at least 2 x106 CD34+/kg (time frame: 5 days). 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 NCT03244930, which also lists 5 linked publications.

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 10 Aug 2017.

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