- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244930
Low Dose Plerixafor Plus G-CSF in Mobilizing Stem Cells for Autologous Peripheral Blood Transplantation
August 9, 2017 updated by: David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Perla Colunga, MD
- Phone Number: +528110761973
- Email: alrep_rcp@hotmail.com
Study Contact Backup
- Name: Dalila Alvarado, MD
- Email: dalila_alvarado@hotmail.com
Study Locations
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico, 64460
- Recruiting
- Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo Leon
-
Contact:
- Perla Colunga Pedraza, MD
- Phone Number: +528110761973
- Email: colunga.perla@gmail.com
-
Contact:
- Guillermo Sotomayor Duque, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Plerixafor 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Harvest of of at least 2 x106 CD34+/kg
Time Frame: 5 days
|
percentage of patients with a target yields of at least 2 x 106 CD34+ cells/kg in one single aphaeresis procedure.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to engraftment
Time Frame: 100 days
|
Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl
|
100 days
|
Rate of patients reaching a peripheral blood precount higher than 20 cells/μL
Time Frame: 5 days
|
Rate of patients reaching a peripheral blood precount higher than 20 cells/μL
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: David Gomez Almaguer, md, Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez"
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2017
Primary Completion (Anticipated)
May 10, 2018
Study Completion (Anticipated)
June 10, 2018
Study Registration Dates
First Submitted
August 7, 2017
First Submitted That Met QC Criteria
August 9, 2017
First Posted (Actual)
August 10, 2017
Study Record Updates
Last Update Posted (Actual)
August 10, 2017
Last Update Submitted That Met QC Criteria
August 9, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE17-00007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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