Study of the Best Timing for Plerixafor in Autologous Hematopoietic Stem Cell Collection
Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-myeloma
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 6, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 27, 2011
September 1, 2011
1.8 years
January 5, 2010
September 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection
After collection
Secondary Outcomes (2)
Median and average neutrophil and platelet engraftment
After stem cell infusion
Plerixafor-related toxicities
1 month after stem cell infusion
Study Arms (1)
Plerixafor
EXPERIMENTALPlerixafor 16 hours
Interventions
Plerixafor administered at 16 hours prior to apheresis
Eligibility Criteria
You may qualify if:
- Autologous donors age 18 to 75 years with NHL or MM scheduled to undergo peripheral blood stem cell collection as part of standard clinical care. Biopsy-confirmed diagnosis of NHL or MM is to have been done prior to the first mobilization.
- In first or second CR or PR
- ECOG performance status of 0 or 1
- WBC count greater than 2.5 x 10e9/1
- Absolute PMN count greater than 1.5 x 10e9/1
- PLT count greater than 100 x 10e9/1
- Serum creatinine less than or equal to 2.2 mg/dl
- SGOT, SGPT, and total bilirubin less than 2.5 X upper limit of normal (ULN)
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
- Negative for HIV
- weeks since last cycle of chemotherapy. (Rituximab, thalidomide, dexamethasone, and bortezomib are not considered chemotherapy for the purpose of the study)
- Patients of childbearing potential agree to use an approved form of contraception
- Recovered from all acute toxic effects of prior chemotherapy
You may not qualify if:
- Comorbid condition which renders patient, in view of the investigators, at high risk of treatment complications
- Failed previous stem cell collections or collection attempts
- Less than 6 weeks of carmustine prior to the 1st dose of G-CSF
- Received GM-CSF or pegfilgrastim within 3 weeks prior to the 1st dose of G-CSF for mobilization
- Received G-CSF within 14 days prior to the 1st dose of G-CSF for mobilization
- Active CNS involvement
- Active brain metastases or carcinomatous meningitis
- Bone marrow involvement greater than 20 percent
- Received radiation therapy to the pelvis
- Post-transplant chemotherapy and/or radiation therapy below the diaphragm is anticipated
- Received prior radio-immunotherapy with Zevalin or Bexxar
- Fever (temperature greater than 38 C/100.4 F)
- Received bone-seeking radionuclides (e.g., holmium)
- A residual acute medical condition resulting from prior chemotherapy
- Active brain metastases or myelomatous meningitis
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shi, Patricia, M.D.lead
- Genzyme, a Sanofi Companycollaborator
Study Sites (1)
Mount Sinai School of Medicine
New York, New York, 10029, United States
Related Publications (2)
Liles WC, Rodger E, Broxmeyer HE, Dehner C, Badel K, Calandra G, Christensen J, Wood B, Price TH, Dale DC. Augmented mobilization and collection of CD34+ hematopoietic cells from normal human volunteers stimulated with granulocyte-colony-stimulating factor by single-dose administration of AMD3100, a CXCR4 antagonist. Transfusion. 2005 Mar;45(3):295-300. doi: 10.1111/j.1537-2995.2005.04222.x.
PMID: 15752146BACKGROUNDDiPersio 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: 19720922BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia A Shi, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Hematology-Oncology
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 6, 2010
Study Start
February 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
September 27, 2011
Record last verified: 2011-09