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

Primary Purpose

Lymphoma, Non-Hodgkin, Lymphoma, Hodgkin, Myeloma

Status

Unknown status

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Plerixafor 0.12 mg/kg

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to engraftment

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

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

Full Information

NCT ID

NCT03244930

First Posted

August 7, 2017

Last Updated

August 9, 2017

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

1. Study Identification

Unique Protocol Identification Number

NCT03244930

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 10, 2017 (Actual)

Primary Completion Date

May 10, 2018 (Anticipated)

Study Completion Date

June 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Non-Hodgkin, Lymphoma, Hodgkin, Myeloma, Stem Cell Transplant Complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Prospective, open-labeled, single-arm study

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Plerixafor 0.12 mg/kg

Other Intervention Name(s)

mozobil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Harvest of of at least 2 x106 CD34+/kg

Description

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

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Time to engraftment

Description

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

Time Frame

100 days

Title

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

Description

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

Time Frame

5 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Perla Colunga, MD

Phone

+528110761973

alrep_rcp@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dalila Alvarado, MD

dalila_alvarado@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Gomez Almaguer, md

Organizational Affiliation

Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez"

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Perla Colunga Pedraza, MD

Phone

+528110761973

colunga.perla@gmail.com

First Name & Middle Initial & Last Name & Degree

Guillermo Sotomayor Duque, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19720922

Citation

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.

Results Reference

result

PubMed Identifier

20067838

Citation

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.

Results Reference

result

PubMed Identifier

20530974

Citation

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.

Results Reference

result

PubMed Identifier

28067870

Citation

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.

Results Reference

result

PubMed Identifier

31618456

Citation

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.

Results Reference

derived

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

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