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ATRA Plus G-CSF for Mobilization of Hematopoietic Stem and Progenitor Cells

NCT00400556 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2006-11-17

No results posted yet for this study

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

Conditions

Interventions

DRUG

ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Kirsten E Herbert, MBBS · Peter MacCallum Cancer Center

  • Miles Prince, MBBS · Peter MacCallum Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Completion
2005-05-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00400556 on ClinicalTrials.gov