Plerixafor Harvesting And No Chemotherapy for Transplantation of Autologous STem Cells In Cancer (PHANTASTIC) (PHANTASTIC)

August 20, 2010 updated by: University of Liverpool

A Comparison of Plerixafor/G-CSF With Chemotherapy/G-CSF for Stem Cell Mobilisation

To assess the efficacy and toxicity of plerixafor (AMD 3100) together with granulocyte-colony stimulating factor (G-CSF) for stem cell mobilisation, in patients with myeloma or lymphoma requiring high dose chemotherapy with stem cell rescue.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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 Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • Recruiting
        • Dept of Haematology, University of Liverpool
        • Principal Investigator:
          • Richard E Clark, BA, MB, BS

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All of the following must be satisfied:

Aged 18 or over

Able to give informed written consent.

Diagnosis of EITHER multiple myeloma or related plasma cell dyscrasia, OR any form of lymphoma or associated lymphoproliferative disease Autologous stem cell transplantation is planned as the next course of treatment.

The patient has not previously undergone a mobilisation attempt for the current transplant. Patients who have received previous autologous transplants at least 2 years previously are eligible, as long as stem cell mobilisation has not been attempted for the current transplant.

No serious concomitant illness (e.g. heart disease) that might preclude completion of the study.

Creatinine clearance of at least 30 mls/min. Note that a dose reduction of plerixafor is required where the creatinine clearance is between 30-50 mls/min; see section 3.3/5.1/5.3.

Negative pregnancy test in women of childbearing age.

Exclusion Criteria:

  • Unable to give informed written consent

Pregnancy or lactating

Creatinine clearance of less than 30 mls/min. Patients with clearances lower than this may still be able to receive plerixafor at reduced dosage following discussion with the trial co-ordinators, but are not eligible for entry into this trial.

Any previous attempt at mobilisation for the current transplant. Patients with any form of leukaemia, INCLUDING PLASMA CELL LEUKAEMIA, are not eligible.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A composite primary endpoint of BOTH an adequate stem cell harvest (≥4 x 106 CD34+/kg in no more than 2 aphereses); AND a neutrophil count that never falls below 1.0 x 109 / Litre in the 3 weeks following initiation of mobilisation.
Time Frame: 3 weeks following initiation of mobilisation
3 weeks following initiation of mobilisation

Secondary Outcome Measures

Outcome Measure
Time Frame
Serial neutrophil and platelet counts during mobilisation
Time Frame: 1 Day
1 Day
Total stem cell yield in 1-2 aphereses
Time Frame: 1 day
1 day
The usage of plerixafor and the number and timing of apheresis collections
Time Frame: 1 day
1 day
The time to neutrophil engraftment after subsequent transplantation
Time Frame: First of 2 consecutive days on which the neutrophil count equals or exceeds 0.5 x 109/litre
First of 2 consecutive days on which the neutrophil count equals or exceeds 0.5 x 109/litre
The time to platelet engraftment after subsequent transplantation
Time Frame: First of two consecutive days on which the platelet count equals or exceeds 50 x 109/litre, having been free of platelet transfusion for at least 48 hours
First of two consecutive days on which the platelet count equals or exceeds 50 x 109/litre, having been free of platelet transfusion for at least 48 hours

Collaborators and Investigators

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

Sponsor

University of Liverpool

Collaborators

Genzyme, a Sanofi Company

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

May 1, 2010

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

August 18, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

August 23, 2010

Last Update Submitted That Met QC Criteria

August 20, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHANTASTIC
  • 2009-013798-16 (EudraCT Number)

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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