MedDataX Logo

Use of Topotecan in Patients With Refractory Acute Leukemia

NCT ID: NCT00100477

Last Updated: 2013-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-08-31

Study Completion Date

2001-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Hodgkin's Lymphoma Leukemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Multiple Myeloma Lymphoma Leukemia Etoposide Drug Therapy Clinical Trials

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type OTHER

Topotecan

Intervention Type DRUG

Mitozantrone

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topotecan

Intervention Type DRUG

Mitozantrone

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients in the following disease categories will be considered eligible for this study:

* Any acute leukemia beyond an initial attempt to induce a remission or after relapse
* Chronic Myelogenous Leukemia in Blast Phase
* Refractory Multiple Myeloma
* Refractory non-Hodgkin's and Hodgkin's Lymphoma
* Patients must be more than 14 days beyond prior myelotoxic chemotherapy
* Several other eligibility criteria apply.

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Immunex Corporation

INDUSTRY

Sponsor Role collaborator

SmithKline Beecham

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark Mainwaring

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CADE-RCD1

Identifier Type: -

Identifier Source: org_study_id