Back to resultsIUdR/BUdR Cell Cycle Labelling
Primary Purpose
Hematologic Malignancies
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chemotherapy for hematologic malignancy
Sponsored by
About this trial
This is an interventional diagnostic trial for Hematologic Malignancies focused on measuring Cell Cycle Interphase, G0, G1, G2, S Phase
Eligibility Criteria
Histologic proof of one of: AML, ALL, or AUL MDS or CMML CML OR undergoing bone marrow transplantation. Participants should be: off therapy for at least two weeks At least 18 years old or older Using adequate contraception if of child-bearing capability.
Sites / Locations
- M.D. Anderson Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00042250
First Posted
July 24, 2002
Last Updated
January 20, 2012
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00042250
Brief Title
IUdR/BUdR Cell Cycle Labelling
Official Title
Cell Cycle Kinetics in Vivo in Patients With Hematologic Malignancies Studied by Iododeoxyuridine and Bromodeoxyuridine Labelling
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 1992 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine cell cycle parameters and changes after treatment, the labelling agent is given and a bone marrow aspiration is accomplished before treatment and after treatment for comparison. Participants must be undergoing concurrent therapy for hematologic malignancy.
Detailed Description
Cell cycle parameters include LI, Ts, Tc, T dpot, changes in these parameters, and differences between normal and leukemic cells in patients with hematologic malignancy prior to and following treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
Cell Cycle Interphase, G0, G1, G2, S Phase
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Chemotherapy for hematologic malignancy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Histologic proof of one of:
AML, ALL, or AUL
MDS or CMML
CML
OR undergoing bone marrow transplantation.
Participants should be:
off therapy for at least two weeks
At least 18 years old or older
Using adequate contraception if of child-bearing capability.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Andreeff, MD, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M. D. Anderson Cancer Center
Learn more about this trial
IUdR/BUdR Cell Cycle Labelling
We'll reach out to this number within 24 hrs