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

NCT03244930 | Unknown Phase 2 DMC

• 1 other identifier: HE17-00007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  5 days

Secondary Outcomes (2)

• Time to engraftment

  100 days

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

  5 days

Study Arms (1)

Arm 1

EXPERIMENTAL

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.

Drug: Plerixafor 0.12 mg/kg

Interventions

Plerixafor 0.12 mg/kg 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.

Also known as: mozobil

Arm 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

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

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (5)

• 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.

  PMID: 19720922 RESULT

• 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.

  PMID: 20067838 RESULT

• 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.

  PMID: 20530974 RESULT

• 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.

  PMID: 28067870 RESULT

• 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.

  PMID: 31618456 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease; Neoplasms, Plasma Cell

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• David Gomez Almaguer, md

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

  STUDY DIRECTOR

Central Study Contacts

Perla Colunga, MD

CONTACT

+528110761973; alrep_rcp@hotmail.com

Dalila Alvarado, MD

CONTACT

dalila_alvarado@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematology division chief

Model Details: Prospective, open-labeled, single-arm study

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: May 10, 2017
• Primary Completion: May 10, 2018
• Study Completion: June 10, 2018
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

ME (1)