Non-Hodgkin's LymphomaPhase 2NCT00100477
Use of Topotecan in Patients With Refractory Acute Leukemia
A Phase 2 study testing Topotecan, Mitozantrone and Etoposide in people with Non-Hodgkin's Lymphoma and Leukemia, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Leukemia
- What is being tested?
- Topotecan, Mitozantrone and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Jun 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
Official title: Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia
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).
Read the detailed description
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
- Non-Hodgkin's Lymphoma, Leukemia
- Keywords
- Multiple Myeloma, Lymphoma, Leukemia, Etoposide, Drug Therapy, Clinical Trials
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Drug: Topotecan; Drug: Mitozantrone; Drug: Etoposide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2004 (estimated)
- Study startAug 1998
- Primary completionJan 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Immunex Corporation, SmithKline Beecham, Amgen
- Responsible party
- Sponsor
- Investigators
- Mark Mainwaring, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100477
- Sponsor's protocol ID
- CADE-RCD1
- Status last verified
- Sep 2013
- First submitted
- 30 Dec 2004
- Last updated
- 25 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia
- ClinicalTrials.gov ID
- NCT00100477
- Acronym / sponsor ID
- CADE-RCD1
- Conditions
- Non-Hodgkin's Lymphoma, Leukemia
- Keywords
- Multiple Myeloma, Lymphoma, Leukemia, Etoposide, Drug Therapy, Clinical Trials
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Immunex Corporation, SmithKline Beecham, Amgen
- Study start
- Aug 1998
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 31 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Topotecan, Drug: Mitozantrone, Drug: Etoposide |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topotecan | Drug | Arm 1 |
| Mitozantrone | Drug | Arm 1 |
| Etoposide | Drug | Arm 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Mainwaring principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topotecan, Mitozantrone and Etoposide in people with Non-Hodgkin's Lymphoma and Leukemia, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2013.