Study of the Best Timing for Plerixafor in Autologous Hematopoietic Stem Cell Collection

September 26, 2011 updated by: Patricia Shi, Shi, Patricia, M.D.

Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The current FDA-approved timing for plerixafor is approximately 11 hours prior to apheresis. This is a logistical problem, since plerixafor should be administered by a health care provider, given the risk of hypotension with administration. The primary purpose of this study is, in autologous donors with non-Hodgkins lymphoma and multiple myeloma undergoing hematopoietic progenitor cell mobilization with plerixafor and G-CSF, to determine whether the dosing interval can be increased to 16 hours prior to apheresis. Patients will be admitted to a special clinical research center on the 4th day of G-CSF administration, where the peripheral blood CD34+ count will be measured every 2 hours after plerixafor administration at 5 pm until 9 AM the following day, at which time apheresis will commence. The hypothesis is that plerixafor administration 16 hours prior to apheresis is as safe and effective as plerixafor administration at 11 hours prior to apheresis.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia A Shi, MD
        • Sub-Investigator:
          • Luis M Isola, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. In first or second CR or PR
  3. ECOG performance status of 0 or 1
  4. WBC count greater than 2.5 x 10e9/1
  5. Absolute PMN count greater than 1.5 x 10e9/1
  6. PLT count greater than 100 x 10e9/1
  7. Serum creatinine less than or equal to 2.2 mg/dl
  8. SGOT, SGPT, and total bilirubin less than 2.5 X upper limit of normal (ULN)
  9. Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
  10. Negative for HIV
  11. 4 weeks since last cycle of chemotherapy. (Rituximab, thalidomide, dexamethasone, and bortezomib are not considered chemotherapy for the purpose of the study)
  12. Patients of childbearing potential agree to use an approved form of contraception
  13. Recovered from all acute toxic effects of prior chemotherapy

Exclusion Criteria:

  1. Comorbid condition which renders patient, in view of the investigators, at high risk of treatment complications
  2. Failed previous stem cell collections or collection attempts
  3. Less than 6 weeks of carmustine prior to the 1st dose of G-CSF
  4. Received GM-CSF or pegfilgrastim within 3 weeks prior to the 1st dose of G-CSF for mobilization
  5. Received G-CSF within 14 days prior to the 1st dose of G-CSF for mobilization
  6. Active CNS involvement
  7. Active brain metastases or carcinomatous meningitis
  8. Bone marrow involvement greater than 20 percent
  9. Received radiation therapy to the pelvis
  10. Post-transplant chemotherapy and/or radiation therapy below the diaphragm is anticipated
  11. Received prior radio-immunotherapy with Zevalin or Bexxar
  12. Fever (temperature greater than 38 C/100.4 F)
  13. Received bone-seeking radionuclides (e.g., holmium)
  14. A residual acute medical condition resulting from prior chemotherapy
  15. Active brain metastases or myelomatous meningitis
  16. Received thalidomide, dexamethasone and/or Velcade within 7 days prior to the first dose of G-CSF
  17. Received Revlimid within 3 weeks prior to the first dose of G-CSF
  18. Received greater than 6 cycles of Revlimid
  19. Positive pregnancy test or lactating
  20. Active infection requiring antibiotic treatment
  21. Abnormal ECG with clinically significant rhythm disturbance (ventricular arrhythmias), or other conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial.
  22. Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase.
  23. Patients whose apheresis product will be further selected and purified.
  24. Prior autologous or allogeneic transplant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plerixafor
Plerixafor 16 hours
Drug: Plerixafor
Plerixafor administered at 16 hours prior to apheresis
Other Names:
  • Mozobil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection
Time Frame: After collection
After collection

Secondary Outcome Measures

Outcome Measure
Time Frame
Median and average neutrophil and platelet engraftment
Time Frame: After stem cell infusion
After stem cell infusion
Plerixafor-related toxicities
Time Frame: 1 month after stem cell infusion
1 month after stem cell infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shi, Patricia, M.D.

Collaborators

Genzyme, a Sanofi Company

Investigators

  • Principal Investigator: Patricia A Shi, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 26, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO # 09-0824

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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