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

This study is currently recruiting participants.
Verified August 2017 by David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
Sponsor:
ClinicalTrials.gov Identifier:
NCT03244930
First Posted: August 10, 2017
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
  Purpose
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.

Condition Intervention Phase
Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Myeloma Stem Cell Transplant Complications Drug: Plerixafor 0.12 mg/kg Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, open-labeled, single-arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation

Resource links provided by NLM:


Further study details as provided by David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Harvest of of at least 2 x106 CD34+/kg [ Time Frame: 5 days ]
    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 [ Time Frame: 100 days ]
    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 [ Time Frame: 5 days ]
    Rate of patients reaching a peripheral blood precount higher than 20 cells/μL


Estimated Enrollment: 20
Actual Study Start Date: May 10, 2017
Estimated Study Completion Date: June 10, 2018
Estimated Primary Completion Date: May 10, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: mozobil

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.
  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244930


Contacts
Contact: Perla Colunga, MD +528110761973 alrep_rcp@hotmail.com
Contact: Dalila Alvarado, MD dalila_alvarado@hotmail.com

Locations
Mexico
Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo Leon Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Perla Colunga Pedraza, MD    +528110761973    colunga.perla@gmail.com   
Contact: Guillermo Sotomayor Duque, MD         
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Study Director: David Gomez Almaguer, md Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez"
  More Information

Publications:

Responsible Party: David Gomez Almaguer, Hematology division chief, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03244930     History of Changes
Other Study ID Numbers: HE17-00007
First Submitted: August 7, 2017
First Posted: August 10, 2017
Last Update Posted: August 10, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents