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

NCT ID: NCT03244930

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2018-06-10

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Plerixafor 0.12 mg/kg

Intervention Type: DRUG

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.

Interventions

Plerixafor 0.12 mg/kg

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.

Intervention Type: DRUG

Other Intervention Names

mozobil

Eligibility Criteria

Inclusion Criteria

1. Candidates planned for an autologous haematopoietic stem cell transplantation without previous mobilization attempts with chemotherapy.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

3. WBC count ≥2.5x109/L.

4. Absolute neutrophil count ≥1.5x109/L.

5. Platelet count ≥100x109/L

Exclusion Criteria

1. Prior allogeneic or autologous transplantation.

2. Pregnant women.

3. 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.

4. Positive serology for hepatitis B or C or HIV.

5. Left ventricular ejection fraction < 40%

6. AST ALT >2.5x or Creatinine >2 md/dL

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role: lead

Responsible Party

David Gomez Almaguer

Hematology division chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Gomez Almaguer, md

Role: STUDY_DIRECTOR

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

Locations

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

Monterrey, Nuevo León, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Perla Colunga, MD

Role: CONTACT

alrep_rcp@hotmail.com

+528110761973

Dalila Alvarado, MD

Role: CONTACT

dalila_alvarado@hotmail.com

Facility Contacts

Perla Colunga Pedraza, MD

Role: primary

colunga.perla@gmail.com

+528110761973

Guillermo Sotomayor Duque, MD

Role: backup

References

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.

Reference Type: RESULT

PMID: 19720922 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20067838 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20530974 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28067870 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31618456 (View on PubMed)

Other Identifiers

HE17-00007

Identifier Type: -

Identifier Source: org_study_id