Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation

NCT06892119 | Completed Phase 1

• 1 other identifier: HE19-00013
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Generic plerixafor use at reduced-dose for mobilization on HSCT transplant

Conditions

Lymphoma; Myeloma

Outcome Measures

Primary Outcomes (1)

• Post-RD plerixafor increase in CD34+/μL pre-count, final CD34+ cell yield and harvest

  The objective of this study is to demonstrate that the use of a low dose of the generic form of plerixafor is effective in increasing the amount of hematopoietic cells (stem cells).

  1 year

Study Arms (2)

Generic plerixafor

ACTIVE COMPARATOR

Use a reduced-dose of generic plerixafor (0.12 mcg/Kg)

Drug: Celrixafor

Placebo

PLACEBO COMPARATOR

Use of a subcutaenous application of saline solution

Drug: Celrixafor

Interventions

Celrixafor DRUG

Use a reduced-dose of generic plerixafor

Generic plerixafor; Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with lymphoma or multiple myeloma who are candidates for autoHSCT
• Patients \> 18 years old who signed our informed consent
• Normal CBC count (Hb \> 10, WBC 4.0-11.00, plt \> 100,000)

You may not qualify if:

• Patients with HIV, Hepatitis C, Hepatitis B diagnosis
• Pregnant women

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Lymphoma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Olga G Cantú-Rodríguez, MD

  Universidad Autónoma de Nuevo León

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient receive a subcutaenous application (placbe vs generic plerixafor)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel study comparing placebo vs generic plerixafor

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: March 24, 2025
• Study Start: December 9, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)