Generic Plerixafor Efficacy of Autologous Hematopoietic Stem Cell Transplantation

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Completed; Phase 1

Conditions: Lymphoma; Myeloma

Treatments: Drug: Celrixafor

Study type: Interventional

Funder types: Other

Identifiers

NCT06892119

HE19-00013

Details and patient eligibility

About

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

Full description

The objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant. Plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups, including a placebo group

Generic plerixafor

Active Comparator group

Description:

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

Treatment:

Drug: Celrixafor

Placebo

Placebo Comparator group

Description:

Use of a subcutaenous application of saline solution

Treatment:

Drug: Celrixafor