Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00901225
First received: May 4, 2009
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population.

The study hypothesis for this study is that patients with a circulating CD34+ count < 20 cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.


Condition Intervention Phase
Multiple Myeloma
Non-Hodgkins Lymphoma
Hodgkins Disease
Drug: G-CSF plus Plerixafor
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Plerixafor Rescue Mobilization For Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF. [ Time Frame: 5 days after receiving G-CSF ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Experiencing a Grade III/IV Toxicity [ Time Frame: 6 months post transplant or until relapse ] [ Designated as safety issue: Yes ]
    Safety of plerixafor as measured by Grade III/IV Toxicity

  • Number of Subjects Experiencing Graft Failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To investigate the hematological activity of Plerixafor as measured by Graft Failure. Graft failure is defined as failure of initial engraftment (primary graft failure) or initial engraftment, but subsequent loss of hematopoiesis (secondary graft failure).

  • Days to Absolute Neutrophil Count >500 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of Subjects Experiencing Durability of Engraftment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Durability of engraftment is defined as the duration and stability of hematopoiesis following autologous transplantation. Subjects who experience durable engraftment have neutrophil counts greater than 500 and platelet counts greater than 20,000 within the specified time frame.

  • Platelet Engraftment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Days to platelet count >20,000


Enrollment: 21
Study Start Date: May 2009
Study Completion Date: May 2013
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-CSF plus Plerixafor
Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
Drug: G-CSF plus Plerixafor

On Day 5 of G-CSF mobilization,

  1. if the patient's peripheral CD34+ cell count is < 7cells/µl then 240ug/kg Plerixafor will be given in the evening prior to receiving 10µg/kg G-CSF and undergoing apheresis the next morning for up to 3 days of apheresis or until ≥ 5x10(6) cells/kg are collected.
  2. if the patient's peripheral CD34+ cell count is 7 to 19 cells/ul (inclusive), apheresis will be done. If the apheresis yield is < 1.3x10(6) CD34+ cells/kg then 240ug/kg Plerixafor will be given in the evening prior to receiving 10 µg/kg G-CSF and undergoing apheresis the next morning. If the apheresis yield is at least double that on Day 5, Plerixafor followed the next morning by G-CSF and apheresis will be repeated for up to a total of 3 days of apheresis or until 5x10(6) cells/kg are collected.
Other Name: Mozobil, AMD3100

Detailed Description:

This is a single-center, Phase 2, open-label study. All patients diagnosed with non-hodgkins lymphoma, hodgkins disease or multiple myeloma and candidates for autologous transplantation are eligible to enter into the study. The only change to the standard of care is the addition of 240 ug/kg Plerixafor following 5 days of (G-CSF) mobilization.

The results of the study will provide both numeric and categorical estimates of measurements of the safety and efficacy of Plerixafor. The primary efficacy endpoint, Treatment Success, is a binary response variable categorizing whether the patient was able to mobilize at least 2 X 10(6) CD34+ cells/kg within 3 days of apheresis.

The percentage of patients achieving Treatment Success will be summarized. All AEs will be followed for 30 days after the last apheresis or until the first dose of ablative chemotherapy, whichever occurs first. All SAEs will be followed for 6 months post-transplant or until relapse. All patients who receive at least one dose of Plerixafor will be included in all summaries of AEs.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 75 years.
  • Diagnosis of NHL, HD or MM
  • Eligible for autologous transplantation
  • CD34+ cell count < 7 cells/ul after 5 days of mobilization with G-CSF or CD34+ cell count between 7 and 19 (inclusive) on day 5 of mobilization with G-CSF and < 1.3 x 106 CD34+ cells collected by apheresis on day 5 of G-CSF therapy.
  • < or equal to 5 prior regimens of chemotherapy (Rituxan is not considered chemotherapy for the purpose of this study)
  • ≥ 3 weeks since last cycle of chemotherapy and the beginning of G-CSF mobilization (Rituxan and Lenalidomide are not considered chemotherapy for the purpose of this study)
  • Total dose of melphalan < or equal to 200 mg
  • ECOG performance status of 0 or 1
  • Recovered from all acute toxic effects of prior chemotherapy
  • Absolute PMN count > 1.0 X 10(9)/l prior to first dose of G-CSF
  • PLT count > 75 X 10(9)/l prior to first dose of G-CSF
  • Serum creatinine < or equal to 2.5 mg/dl
  • SGOT, SGPT and total bilirubin < 2 X upper limit of normal (ULN) prior to the first dose of G-CSF
  • Cardiac and pulmonary status sufficient to undergo apheresis and transplantation as determined by standard institutional practice
  • Signed informed consent
  • Patients of childbearing potential agree to use an approved form of contraception

Exclusion Criteria:

  • A co-morbid condition which, in the view of the investigator, renders the patient at high risk from treatment complications
  • Failed previous stem cell collection or collection attempts
  • A residual acute medical condition resulting from prior chemotherapy
  • Active brain metastases or carcinomatous meningitis
  • Active infection requiring antibiotic treatment (excluding controlled catheter-related bacteremia)
  • Received prior radio-immunotherapy with Zevalin or Bexxar
  • Received thalidomide, dexamethasone, and/or Velcade within 7 days prior to the first dose of G-CSF
  • Positive pregnancy test in female patients
  • Lactating females
  • Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901225

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Mitchell Horwitz, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00901225     History of Changes
Other Study ID Numbers: Pro00014563
Study First Received: May 4, 2009
Results First Received: October 30, 2013
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
NHL

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014