LeukemiaPhase 2NCT00003758
Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia
A Phase 2 study testing cytarabine, idarubicin and allogeneic bone marrow transplantation in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 7 countries.
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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Leukemia
- What is being tested?
- cytarabine, idarubicin and allogeneic bone marrow transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 16 sitesin 7 countries
- Study dates
- Dec 1998to not given
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: First bone marrow relapse of primary acute myelogenous leukemia (AML), all subtypes except M3 OR First bone marrow relapse of secondary AML that occurred after other malignancies, but cured, or after alkylating agents and/or radiotherapy, or after myelodysplastic syndrome No previously untreated AML or second or subsequent relapse of AML No isolated extramedullar localization of AML Must have achieved a first complete remission No leukemias after other myeloproliferative diseases
PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN AST no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No cardiac contraindications to anthracycline chemotherapy Ventricular ejection fraction at least 45% Other: No uncontrolled infection No concurrent severe neurological or psychiatric disease No other progressive malignant nonhematological disease
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic or autologous bone marrow or peripheral stem cell transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Belgium4 sites
Algemeen Ziekenhuis Middelheim
Antwerp, 2020
A.Z. St. Jan
Bruges, 8000
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
Netherlands4 sites
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, 5211 NL
Leiden University Medical Center
Leiden, 2300 ZA
University Medical Center Nijmegen
Nijmegen, NL-6252 HB
Sint Joseph Ziekenhuis
Veldhoven, 5500 MB DB
Croatia2 sites
Medical School/University of Zagreb
Zagreb, 41000
University Hospital Rebro
Zagreb, 41000
Italy2 sites
Ospedale San Eugenio
Rome, 00144
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168
Turkey (Türkiye)1 site
Ibn-i Sina Hospital, Ankara Univeristy
Ankara, 06100
About this study
Official title: Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside (ARA-C) Plus Interspaced Continuous Infusion Idarubicin, Followed by Continuous Infusion of Low-Dose ARA-C, A Phase II Study by the EORTC-LCG
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.
Read the detailed description
OBJECTIVES: I. Assess the feasibility and efficacy of intermediate dose cytarabine plus idarubicin followed by low dose cytarabine in patients with relapsed acute myelogenous leukemia.
OUTLINE: This is a multicenter study. Patients receive intermediate dose cytarabine IV over 2 hours twice a day on days 1-5, idarubicin IV over 24 hours on days 1, 3, and 5, and low dose cytarabine IV over 24 hours on days 6-15. If patients achieve complete remission by day 35, this regimen is repeated once. If patients achieve partial remission by day 35, this regimen is repeated, except with an additional day of idarubicin on day 7. If these patients then achieve complete remission by day 70, the regimen is repeated. Patients may then undergo stem cell transplantation within 6 months of achieving complete remission. Patients who have an HLA identical sibling available receive an allogeneic transplant; others receive an autologous transplant. Patients are followed monthly for 1 year, every 3 months for 3 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 24-60 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- cytarabine, idarubicin, allogeneic bone marrow transplantation, autologous bone marrow transplantation, peripheral blood stem cell transplantation
- Keywords
- recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, adult acute monoblastic leukemia and acute monocytic leukemia (M5), childhood acute monoblastic leukemia and acute monocytic leukemia (M5), adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute eosinophilic leukemia, adult acute basophilic leukemia, adult acute megakaryoblastic leukemia (M7), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myelomonocytic leukemia (M4), childhood acute erythroleukemia (M6), childhood acute eosinophilic leukemia, childhood acute basophilic leukemia, childhood acute megakaryocytic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), childhood acute minimally differentiated myeloid leukemia (M0)
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Basophilic, Acute, Leukemia, Megakaryoblastic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytarabineDrug
idarubicinDrug
allogeneic bone marrow transplantationProcedure or surgery
autologous bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2004 (estimated)
- Study startDec 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.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Investigators
- Petra Muus, MD, PhD, Study chair, Universitair Medisch Centrum St. Radboud - Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003758
- Sponsor's protocol ID
- CDR0000066882
- Other IDs
- EORTC-06956
- Status last verified
- Jan 2001
- First submitted
- 1 Nov 1999
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside (ARA-C) Plus Interspaced Continuous Infusion Idarubicin, Followed by Continuous Infusion of Low-Dose ARA-C, A Phase II Study by the EORTC-LCG
- ClinicalTrials.gov ID
- NCT00003758
- Acronym / sponsor ID
- CDR0000066882
- Conditions
- Leukemia
- Keywords
- recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, adult acute monoblastic leukemia and acute monocytic leukemia (M5), childhood acute monoblastic leukemia and acute monocytic leukemia (M5), adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Dec 1998
- First posted
- 3 Jun 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.
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.
Detailed description
OBJECTIVES: I. Assess the feasibility and efficacy of intermediate dose cytarabine plus idarubicin followed by low dose cytarabine in patients with relapsed acute myelogenous leukemia.
OUTLINE: This is a multicenter study. Patients receive intermediate dose cytarabine IV over 2 hours twice a day on days 1-5, idarubicin IV over 24 hours on days 1, 3, and 5, and low dose cytarabine IV over 24 hours on days 6-15. If patients achieve complete remission by day 35, this regimen is repeated once. If patients achieve partial remission by day 35, this regimen is repeated, except with an additional day of idarubicin on day 7. If these patients then achieve complete remission by day 70, the regimen is repeated. Patients may then undergo stem cell transplantation within 6 months of achieving complete remission. Patients who have an HLA identical sibling available receive an allogeneic transplant; others receive an autologous transplant. Patients are followed monthly for 1 year, every 3 months for 3 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 24-60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 | – |
| idarubicin | Drug | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
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 9 Feb 2009.
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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.
Petra Muus, MD, PhD study chair
Universitair Medisch Centrum St. Radboud - Nijmegen
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cytarabine, idarubicin and allogeneic bone marrow transplantation in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 7 countries.
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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Belgium, Netherlands, Croatia, France, Italy and 2 more countries. 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?
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 9 Feb 2009.