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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Liverpool.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
University of Liverpool
ClinicalTrials.gov Identifier:
NCT01186224
First received: August 18, 2010
Last updated: August 20, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Multiple Myeloma
Plasma Cell Dyscrasia
Lymphoma
Lymphoproliferative Disorders
Drug: Plerixafor and G-CSF

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Plerixafor/G-CSF With Chemotherapy/G-CSF for Stem Cell Mobilisation

Resource links provided by NLM:


Further study details as provided by University of Liverpool:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serial neutrophil and platelet counts during mobilisation [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
  • Total stem cell yield in 1-2 aphereses [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • The usage of plerixafor and the number and timing of apheresis collections [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Plerixafor and G-CSF

    G-CSF will be given daily from day 1, which will usually be timed to fall toward the end of the working week. Plerixafor will commence on day 4 at as near to 10 PM as practicable, and also on day 5 and subsequent days (maximum of 4 total days) at a similar time of day if insufficient CD34+ cells have been collected. Stem cell harvesting will be carried out on day 5 and if necessary on days 6, 7 and 8, until the target yield of 4 x 106 CD34+ cells /kg recipient weight have been achieved.

    The daily dose of G-CSF is 300 ug for patients up to and including 60kg in weight; 480 ug for patients over 60 kg but under 96 kg, and 600 ug for patients weighing 96 kg or more. This equates to a dose of at least 5 ug/kg (maximum 8 mg/kg) for all patients up to 120 kg. The daily dose of plerixafor is 240 ug/kg if the creatinine clearance is equal to or greater than 50mls/minute; if less than this then the dose is 160 ug/kg daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT01186224

Contacts
Contact: Richard E Clark, BA, MB, BS 0151-706-4297/4344 clarkre@liverpool.ac.uk

Locations
United Kingdom
Dept of Haematology, University of Liverpool Recruiting
Liverpool, Merseyside, United Kingdom, L7 8XP
Principal Investigator: Richard E Clark, BA, MB, BS         
Sponsors and Collaborators
University of Liverpool
Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Prof. Richard E Clark, Dept of Haematology, Royal Liverpool University Hospital
ClinicalTrials.gov Identifier: NCT01186224     History of Changes
Other Study ID Numbers: PHANTASTIC, 2009-013798-16
Study First Received: August 18, 2010
Last Updated: August 20, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 18, 2014