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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00234169
Registration number
NCT00234169
Ethics application status
Date submitted
4/10/2005
Date registered
6/10/2005
Date last updated
10/05/2012
Titles & IDs
Public title
A Study of Peripheral Blood Progenitor Cells Mobilisation (PBPC) With VTP195183 Plus Granulocyte-Colony Stimulating Factor (G-CSF) Compared to Mobilisation With G-CSF Alone
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Scientific title
A Phase I/II Study of Peripheral Blood Progenitor Cells Mobilisation With VTP195183 Plus G-CSF Compared to Mobilisation With G-CSF Alone in Patients With Multiple Myeloma and Lymphoma.
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Secondary ID [1]
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05/09
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - VTP195183
Treatment: Drugs: VTP195183
VTP195183: 60mg/m2 orally daily G-CSF: 10mcg/kg/day subcutaneously Provision is made for dose reduction of VTP195183 in the event of unexpected dose-limiting toxicities G-CSF10mcg/kg/day will commence on day 1 and will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.
Patients will be treated with VTP195183 alone at 60mg/m2/day from day 1 to day 7. On day 8 VTP195183 will be continued and G-CSF10mcg/kg/day will be added. VTP195183 plus G-CSF will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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PB CD34+ kinetics using VTP195183 plus G-CSF
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Assessment method [1]
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Timepoint [1]
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up to 28 days post study drug administration
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Secondary outcome [1]
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The toxicity of VTP195183 pretreatment when used with G-CSF
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Assessment method [1]
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Timepoint [1]
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within 28 days of study drug administration
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Eligibility
Key inclusion criteria
1. Age 18-70
2. Histologically proven multiple myeloma or lymphoma
3. Intent of treating physician to proceed to high dose therapy and autologous
transplantation
4. Not currently receiving thalidomide (within 1 week of commencing VTP195813 or G-CSF),
cytotoxic agents or high dose prednisolone or Dexamethasone (at doses greater than 15
mg prednisolone or equivalent per day)
5. Multiple myeloma patients must be taking regular bisphosphonate therapy
6. Absolute neutrophil count between 1.5 and 10 x 109/L
7. ECOG performance status ? 2
8. Life expectancy of at least 2 months
9. Written informed consent signed by patient or legally authorized representative
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Active infection or a fever > 38.2 degrees C (fever due to B symptoms in lymphoma
patients will not exclude a patient)
2. Use within the previous 30 days of other vitamin A preparations within the last 30
days (including oral vitamin supplements, oral retinoids for acne or other skin
disorders, bexarotene, or topical vitamin A preparations)
3. Pregnancy or breast feeding. Women of child-bearing potential, admitted to the trial
must take adequate measures to prevent conception (at least two different forms of
contraception during the study and for at least one month after completion of study
drugs) and are to undergo a pregnancy test
4. Significant non-malignant disease including HIV infection, uncontrolled hypertension
(diastolic blood pressures > 115 mmHg), unstable angina
5. Known allergy to E.coli-derived products
6. Current treatment with tetracycline antibiotics
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2008
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer centre - Melbourne
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Recruitment postcode(s) [1]
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3002 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Peter MacCallum Cancer Centre, Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Leukemia and Lymphoma Society
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Hematopoietic stem cells (HSC) are used to support the administration of high dose
chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5
million HSC per kilogram are required. HSC are collected from the bone marrow by using drugs
such as G-CSF (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream.
HSC are collected from the bloodstream using an apheresis machine. Between 5 and 60% of
patients fail to mobilize the minimum HSC dose required for safe transplantation, and this
trial is investigating a way to enhance mobilization to overcome this problem. This trial
aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when
used in conjunction with G-CSF. Patients will undergo two mobilization procedures. They will
be given G-CSF alone, or a combination of the study drug plus G-CSF, and their stem cells
will be collected. A comparison group of patients will be given G-CSF alone for both
mobilizations. Stem cells collected from patients in this trial will be frozen and stored
until they are required for transplantation into that patient. At that time, patients will be
monitored for how well they recover from their high dose chemotherapy and HSC
transplantation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00234169
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kirsten Herbert, MBBS
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00234169
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