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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
Information provided by:
University of Liverpool
ClinicalTrials.gov Identifier:
NCT01186224
First received: August 18, 2010
Last updated: August 20, 2010
Last verified: February 2010
History of Changes

August 18, 2010
August 20, 2010
May 2010
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01186224 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Plerixafor Harvesting And No Chemotherapy for Transplantation of Autologous STem Cells In Cancer (PHANTASTIC)
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Plasma Cell Dyscrasia
  • Lymphoma
  • Lymphoproliferative Disorders
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Richard E Clark, BA, MB, BS 0151-706-4297/4344 clarkre@liverpool.ac.uk
United Kingdom
 
NCT01186224
PHANTASTIC, 2009-013798-16
Yes
Prof. Richard E Clark, Dept of Haematology, Royal Liverpool University Hospital
University of Liverpool
Genzyme
Not Provided
University of Liverpool
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP