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

NCT00901225 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00014563
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma; Non-Hodgkins Lymphoma; Hodgkins Disease

Keywords

NHL

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days after receiving G-CSF

Secondary Outcomes (5)

• Number of Participants Experiencing a Grade III/IV Toxicity

  6 months post transplant or until relapse

• Number of Subjects Experiencing Graft Failure

  12 months

• Days to Absolute Neutrophil Count >500

  12 months

• Number of Subjects Experiencing Durability of Engraftment

  12 months

• Platelet Engraftment

  12 months

Study Arms (1)

G-CSF plus Plerixafor

EXPERIMENTAL

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

Interventions

G-CSF plus Plerixafor DRUG

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.

Also known as: Mozobil, AMD3100

G-CSF plus Plerixafor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease

Interventions

Granulocyte Colony-Stimulating Factor; plerixafor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Mitchell E Horwitz, MD, Principal Investigator
• Organization: Duke University Medical Center

mitchell.horwitz@duke.edu

919-668-1045

Study Officials

• Mitchell Horwitz, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 13, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: May 1, 2013
• Last Updated: May 7, 2014
• Results First Posted: May 7, 2014

Record last verified: 2014-04

Locations

US (1)