Plerixafor Harvesting And No Chemotherapy for Transplantation of Autologous STem Cells In Cancer (PHANTASTIC)
Recruitment status was Recruiting
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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 |
- 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 ]
- 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) |
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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 |
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| Contact: Richard E Clark, BA, MB, BS | 0151-706-4297/4344 | clarkre@liverpool.ac.uk |
| United Kingdom | |
| Dept of Haematology, University of Liverpool | Recruiting |
| Liverpool, Merseyside, United Kingdom, L7 8XP | |
| Principal Investigator: Richard E Clark, BA, MB, BS | |
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:
|
Lymphoma Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Paraproteinemias Neoplasms by Histologic Type Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases 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 May 16, 2013