Low Dose Plerixafor Plus G-CSF in Mobilizing Stem Cells for Autologous Peripheral Blood Transplantation
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03244930|
Recruitment Status : Unknown
Verified August 2017 by David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez.
Recruitment status was: Recruiting
First Posted : August 10, 2017
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Myeloma Stem Cell Transplant Complications||Drug: Plerixafor 0.12 mg/kg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, open-labeled, single-arm study|
|Masking:||None (Open Label)|
|Official Title:||Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation|
|Actual Study Start Date :||May 10, 2017|
|Estimated Primary Completion Date :||May 10, 2018|
|Estimated Study Completion Date :||June 10, 2018|
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
- 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.
- 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
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
|Contact: Perla Colunga, MDemail@example.com|
|Contact: Dalila Alvarado, MDfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Guillermo Sotomayor Duque, MD|
|Study Director:||David Gomez Almaguer, md||Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez"|