LeukemiaPhase 3NCT00003602
Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
A Phase 3 study testing cytarabine, etoposide and idarubicin in people with Leukemia and Myelodysplastic Syndromes, run by Riverside Haematology Group at 1 site in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes
- What is being tested?
- cytarabine, etoposide and idarubicin
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 1998to not given
- Phase
- Phase 3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed de novo or secondary acute myeloid leukemia (AML)
- Prior myelodysplasia allowed
- Refractory anemia with excess blasts (RAEB) OR
- RAEB in transformation
- No relapsed AML
- No chronic granulocytic leukemia in transformation
- No CNS disease
PATIENT CHARACTERISTICS:
Age:
- Over 55
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Transaminases no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 2.5 times ULN
Cardiovascular:
- No severe or uncontrolled cardiac failure
Other:
- No serious medical, social, or psychological condition
- Not HIV 1 or 2 seropositive
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No plan for future autograft
Chemotherapy:
- No prior chemotherapy for myelodysplastic syndrome or AML
Endocrine therapy:
- Not specifed
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent aluminum or magnesium-based antacids
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, NE7 7DN
About this study
Official title: A Randomised Study Comparing an Oral Regimen (Idarubicin and Etoposide) With an Intravenous Regimen (MAE) for Consolidation in Patients Over 55 Years With Acute Myeloid Leukaemia in First Complete Remission
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of oral idarubicin and etoposide vs intravenous mitoxantrone, etoposide, and cytarabine as consolidation therapy in patients over 55 years old with acute myeloid leukemia in first complete remission.
- Compare the toxicity of these 2 regimens in these patients.
- Assess the quality of life of these patients.
OUTLINE: This is a randomized study. Patients are stratified according to number of courses of induction therapy required to achieve complete remission.
All patients receive induction chemotherapy consisting of idarubicin IV on days 1-3 and cytarabine IV over 12 hours on days 1-7. Patients receive 1-2 courses of induction chemotherapy to achieve complete remission.
Patients are randomized to one of two treatment arms for consolidation therapy after achieving complete remission.
- Arm I: Patients receive 2 courses of mitoxantrone IV on days 1 and 2, etoposide IV over 1 hour on days 1-5, and cytarabine IV over 12 hours on days 1-5.
- Arm II: Patients receive 2 courses of oral idarubicin and etoposide on days 1-3.
Quality of life is assessed before each course of consolidation chemotherapy and 6-8 weeks after completion of therapy.
Patients are followed until death.
PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Being tested
- cytarabine, etoposide, idarubicin, mitoxantrone hydrochloride
- Keywords
- untreated adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytarabineDrug
etoposideDrug
idarubicinDrug
mitoxantrone hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riverside Haematology Group
- Sponsor type
- University, hospital or other
- Investigators
- Graham Jackson, MD, Study chair, Newcastle-upon-Tyne Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003602
- Sponsor's protocol ID
- CDR0000066675
- Other IDs
- RHG-AML97, EU-98031
- Status last verified
- Jan 2001
- First submitted
- 1 Nov 1999
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study Comparing an Oral Regimen (Idarubicin and Etoposide) With an Intravenous Regimen (MAE) for Consolidation in Patients Over 55 Years With Acute Myeloid Leukaemia in First Complete Remission
- ClinicalTrials.gov ID
- NCT00003602
- Acronym / sponsor ID
- CDR0000066675
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Keywords
- untreated adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Riverside Haematology GroupUniversity, hospital or other
- Study start
- Mar 1998
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission.
Detailed description
OBJECTIVES:
- Compare the efficacy of oral idarubicin and etoposide vs intravenous mitoxantrone, etoposide, and cytarabine as consolidation therapy in patients over 55 years old with acute myeloid leukemia in first complete remission.
- Compare the toxicity of these 2 regimens in these patients.
- Assess the quality of life of these patients.
OUTLINE: This is a randomized study. Patients are stratified according to number of courses of induction therapy required to achieve complete remission.
All patients receive induction chemotherapy consisting of idarubicin IV on days 1-3 and cytarabine IV over 12 hours on days 1-7. Patients receive 1-2 courses of induction chemotherapy to achieve complete remission.
Patients are randomized to one of two treatment arms for consolidation therapy after achieving complete remission.
- Arm I: Patients receive 2 courses of mitoxantrone IV on days 1 and 2, etoposide IV over 1 hour on days 1-5, and cytarabine IV over 12 hours on days 1-5.
- Arm II: Patients receive 2 courses of oral idarubicin and etoposide on days 1-3.
Quality of life is assessed before each course of consolidation chemotherapy and 6-8 weeks after completion of therapy.
Patients are followed until death.
PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cytarabine | Drug | – |
| etoposide | Drug | – |
| idarubicin | Drug | – |
| mitoxantrone hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
Graham Jackson, MD study chair
Newcastle-upon-Tyne Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cytarabine, etoposide and idarubicin in people with Leukemia and Myelodysplastic Syndromes, run by Riverside Haematology Group at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 20 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 Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 20 Sep 2013.