Leukemia, Myelocytic, AcutePhase 2NCT00126321
Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML)
A Phase 2 study testing cladribine in people with Leukemia, Myelocytic, Acute, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the safety and the efficacy of cladribine, high-dose cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelocytic, Acute
- What is being tested?
- cladribine
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2004to Mar 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with relapsed AML with a remission duration of at least 6 months after first complete remission (CR) or of at least 3 months after second (or higher) CR
- Age >= 18 years
- Life expectancy of at least three months (without consideration of AML and complications)
- Eastern Cooperative Oncology Group (ECOG) 0-2 (without consideration of AML and complications)
- Written informed consent
Who cannot join
- Prior therapy of AML with cladribine
- Severe, uncontrolled infection at time of inclusion (enrollment is possible after control of infection)
- Cardiac insufficiency grade III or IV New York Heart Association (NYHA)
- Severe renal insufficiency with a clearance of < 30 ml/min (if not due to AML)
- Severe hepatic insufficiency with bilirubin > 3 mg/dl or AST > 200 U/l (if not due to AML)
- Other severe organ impairment grade III or IV World Health Organization (WHO) (if not due to AML or, in the opinion of the investigator, may not interfere with the procedures in the study)
Show all 10Show fewer
- HIV infection
- Intolerance to study drugs
- Pregnant or breast-feeding women
- Any other malignant disease which will probably affect the course of AML
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical Clinic & Policlinic III, University Bonn
Bonn, 53105
Marie von Lilienfeld-Toal, MD, +49-228-287-22263, m.lilienfeld.toal@uni-bonn.de
Marie von Lilienfeld-Toal, MD
About this study
Official title: Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia
The purpose of this study is to evaluate the safety and the efficacy of cladribine, high-dose cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia.
Read the detailed description
Considerable progress has been made in the induction therapy of acute myeloid leukemia (AML); however, current therapeutic results are still unsatisfactory in those with relapsed disease. The purine nucleoside analogue cladribine (2-chlorodeoxyadenosine, 2-CdA) has been shown to be a safe and active agent in acute myeloid leukemia. Synergistic interaction between cladribine and cytarabine has been demonstrated in preclinical and clinical studies.
The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of cladribine, high-dose cytarabine, and idarubicin in the treatment of patients with relapsed AML. Adult patients of all age groups can be enrolled in the trial, but elderly patients will be treated with a less dose-intensive regimen.
- Conditions
- Leukemia, Myelocytic, Acute
- Being tested
- cladribine
- Keywords
- AML, relapsed, cladribine, chemotherapy
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cladribineDrug
2-chlorodeoxyadenosine, 2-CdA
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate
Measured: continuous
Rate of complete remission
Secondary outcomes (4)
Remission duration
Overall survival
Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival
Course of CD3/CD4+ subpopulation after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2005 (estimated)
- Study startNov 2004
- Primary completionNov 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelocytic, AcuteStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Investigators
- Marie von Lilienfeld-Toal, MD, Principal investigator, Medical Clinic & Policlinic III, University Hospital Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126321
- Sponsor's protocol ID
- CAI
- Status last verified
- Feb 2010
- First submitted
- 2 Aug 2005
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00126321
- Acronym / sponsor ID
- CAI
- Conditions
- Leukemia, Myelocytic, Acute
- Keywords
- AML, relapsed, cladribine, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 3 Aug 2005 (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 evaluate the safety and the efficacy of cladribine, high-dose cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia.
Detailed description
Considerable progress has been made in the induction therapy of acute myeloid leukemia (AML); however, current therapeutic results are still unsatisfactory in those with relapsed disease. The purine nucleoside analogue cladribine (2-chlorodeoxyadenosine, 2-CdA) has been shown to be a safe and active agent in acute myeloid leukemia. Synergistic interaction between cladribine and cytarabine has been demonstrated in preclinical and clinical studies.
The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of cladribine, high-dose cytarabine, and idarubicin in the treatment of patients with relapsed AML. Adult patients of all age groups can be enrolled in the trial, but elderly patients will be treated with a less dose-intensive regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with relapsed AML with a remission duration of at least 6 months after first complete remission (CR) or of at least 3 months after second (or higher) CR
- Age >= 18 years
- Life expectancy of at least three months (without consideration of AML and complications)
- Eastern Cooperative Oncology Group (ECOG) 0-2 (without consideration of AML and complications)
- Written informed consent
Key exclusion criteria (10 listed)
- Prior therapy of AML with cladribine
- Severe, uncontrolled infection at time of inclusion (enrollment is possible after control of infection)
- Cardiac insufficiency grade III or IV New York Heart Association (NYHA)
- Severe renal insufficiency with a clearance of < 30 ml/min (if not due to AML)
- Severe hepatic insufficiency with bilirubin > 3 mg/dl or AST > 200 U/l (if not due to AML)
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 |
|---|---|---|
| cladribine2-chlorodeoxyadenosine, 2-CdA | Drug | – |
Primary outcome
Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate
Time frame: continuous
Rate of complete remission
4 secondary outcomes
Remission duration
Overall survival
Influence of cytogenetic aberrations on remission rate, duration of remission and overall survival
Course of CD3/CD4+ subpopulation after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
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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.
Marie von Lilienfeld-Toal, MD principal investigator
Medical Clinic & Policlinic III, University Hospital Bonn
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 cladribine in people with Leukemia, Myelocytic, Acute, run by University Hospital, Bonn at 1 site in Germany.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Feb 2010. 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 Germany. 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?
Contact Axel Glasmacher, MD (+49-228-287-15507, glasmacher@uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate (time frame: continuous). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 2 Feb 2010.