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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/NCT00400556




Registration number
NCT00400556
Ethics application status
Date submitted
15/11/2006
Date registered
17/11/2006
Date last updated
17/11/2006

Titles & IDs
Public title
ATRA Plus G-CSF for Mobilization of Hematopoietic Stem and Progenitor Cells
Scientific title
A Phase I Study of Haematopoietic Stem Cell Mobilization Using G-CSF With ATRA in Patients With Cutaneous Lymphoma and Multiple Myeloma
Secondary ID [1] 0 0
04/24
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Cutaneous Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination

Treatment: Drugs: ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Toxicity data (NCI-CTC version 2.0 criteria)
Timepoint [1] 0 0
Primary outcome [2] 0 0
skin toxicity
Timepoint [2] 0 0
Primary outcome [3] 0 0
hepatotoxicity
Timepoint [3] 0 0
Primary outcome [4] 0 0
mucosal toxicity
Timepoint [4] 0 0
Primary outcome [5] 0 0
hematologic toxicity
Timepoint [5] 0 0
Primary outcome [6] 0 0
neurologic toxicity
Timepoint [6] 0 0
Primary outcome [7] 0 0
treatment response
Timepoint [7] 0 0
Primary outcome [8] 0 0
CD34+ cell count peak level
Timepoint [8] 0 0
Primary outcome [9] 0 0
time to CD34+ count peak level
Timepoint [9] 0 0
Primary outcome [10] 0 0
time to reach level >5 x 10^6.L
Timepoint [10] 0 0
Primary outcome [11] 0 0
area under curve for duration of time spent with CD34+ count >5 x 10^6/L
Timepoint [11] 0 0
Primary outcome [12] 0 0
peripheral blood colony forming unit assays
Timepoint [12] 0 0
Primary outcome [13] 0 0
peak CFU-GEMM level
Timepoint [13] 0 0
Primary outcome [14] 0 0
time to peak CFU-GEMM level
Timepoint [14] 0 0

Eligibility
Key inclusion criteria
- likely to comply with study protocol

- age of 18-70

- histologically proven multiple myeloma or lymphoma

- not currently receiving cytotoxic agents however thalidomide, prednisolone,
dexamethasone are allowable

- multiple myeloma patients must be receiving regular bisphosphonates

- absolute neutrophil count between 1.5 and 10.0 x 10^9/L

- ECOG performance status </= 3

- life expectancy of at least two months

- written informed consent signed by patient or legally authorised representative
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- use of other vitamin A preparations within the last 30 days

- active infection or fever >/= 38.2 degrees celsius

- 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) and are to undergo a pregnancy test. Oral contraception must not
include low-dose progestogens

- known allergy to E.coli derived products

- current treatment with tetracycline antibiotics

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Leukemia and Lymphoma Society
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients
undergoing high dose therapy for the treatment of a range of cancers.

- HSPC are collected from the bloodstream after treatment with medications that cause the
HSPC to move from the bone marrow into the bloodstream, a process called mobilization

- between 5 and 60% of patients can fail to collect enough HSPC for a transplant, using
current mobilization techniques

- this study aims to assess the safety of combining a derivative of vitamin A, ATRA with
G-CSF (the drug most commonly used to mobilize HSPC)

- ATRA has never been combined with G-CSF for mobilization of HSPC and therefore a study
is needed to assess the safety of this combination, and whether it successfully
mobilizes HSPC
Trial website
https://clinicaltrials.gov/ct2/show/NCT00400556
Trial related presentations / publications
Herbert KE, Walkley CR, Winkler IG, Hendy J, Olsen GH, Yuan YD, Chandraratna RA, Prince HM, Levesque JP, Purton LE. Granulocyte colony-stimulating factor and an RARalpha specific agonist, VTP195183, synergize to enhance the mobilization of hematopoietic progenitor cells. Transplantation. 2007 Feb 27;83(4):375-84. doi: 10.1097/01.tp.0000251376.75347.b4.
Public notes

Contacts
Principal investigator
Name 0 0
Kirsten E Herbert, MBBS
Address 0 0
Peter MacCallum Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00400556