IUdR/BUdR Cell Cycle Labelling | NCT00042250

Studies
IUdR/BUdR Cell Cycle Labelling

NCT00042250

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Jan 24, 2012Estimated

Enrollment

28Actual

Phase

Not Applicable

Conditions

Hematologic Malignancies

Interventions

Chemotherapy for hematologic malignancy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1992

Primary Completion Date

Oct 2002Actual

Completion Date

Oct 2002Actual

First Submitted Date

Jul 24, 2002

First Submission Date that Met QC Criteria

Jul 25, 2002

First Posted Date

Jul 26, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2012

Last Update Posted Date

Jan 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Name	Type	Description	Arm Group Labels	Other Names
Chemotherapy for hematologic malignancy	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Andreeff, MD, PhD	M.D. Anderson Cancer Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M.D. Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
M. D. Anderson Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided