Acute Myeloid LeukemiaPhase 1NCT00839059
Lenalidomide In Patients With Acute Myeloid Leukemia
A Phase 1 study testing lenalidomide in people with Acute Myeloid Leukemia, run by University of Ulm at 6 sites in Germany.
Trial summary
This is a Phase I, open-label, multi-center, dose-escalation study of lenalidomide in adult patients with newly diagnosed, relapsed or refractory acute myeloid leukemia. All patients will receive lenalidomide per oral daily (starting dose is 25 mg/d). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesGermany
- Study dates
- Jan 2009to May 2011
- Phase
- Phase 1
- 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
- Disease state:
- Age > 70 years newly diagnosed AML (including de novo, s-AML, t-AML)considered ineligible for intensive treatment. Ineligibility for intensive treatment has to be documented within the case report forms (Medical/Oncologic History).
- Age > 60 years relapsed/refractory AML in medically fit patients and newly diagnosed AML (including de novo, s- AML,t-AML) in medically unfit patients
- Age 18-60 years: second or higher relapse of AML, not eligible for intensive therapy
- WBC <20x109/l, pretreatment with hydroxyurea is allowed to lower WBC
- Prior chemo-immunotherapy and other study-medications must have been completed 2 weeks before study treatment start. Treatment with hydroxyureas should be discontinued 1 day before initiating dosing with lenalidomide
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- Willingness and ability to comply with scheduled visits,treatment plan, laboratory tests and other study procedures
- Females of childbearing potential (FCBP)† must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from - FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug.
- Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
Who cannot join
- Acute promyelocytic leukemia [t(15;17)]
- bleeding disorder independent of the AML
- uncontrolled infection
- insufficiency of the kidneys (creatinin >1.5x upper normal serum level), of the liver (bilirubin, AST or AP > 2x upper normal serum level)
- severe obstructive or restrictive ventilation disorder
- heart failure NYHA III/IV
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- severe neurological or psychiatric disorder interfering with ability of giving an informed consent
- no consent for registration, storage and processing of the individual disease-characteristics and course
- peripheral neuropathy
- Performance status WHO > 2
- Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
- Pregnancy or breast-feeding
- Known positive for HIV or infectious hepatitis, type A, B or C
- Known hypersensitivity to thalidomide
- Any prior use of lenalidomide
- Drug or alcohol abuse within the last 6 months
- Participating in other studies within the last 2 weeks
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
University Hospital of Bonn
Bonn, 53111
University Hospital of Düsseldorf
Düsseldorf, 40225
Hospital of the Johann Wolfgang Goethe University
Frankfurt, 60596
University Hospital of Hamburg Eppendorf
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30625
University Hospital of Ulm
Ulm, 89081
About this study
Official title: Open-Label, Multi-Center Phase I Dose-Escalation Study With Lenalidomide In Patients With Acute Myeloid Leukemia
This is a Phase I, open-label, multi-center, dose-escalation study of lenalidomide in adult patients with newly diagnosed, relapsed or refractory acute myeloid leukemia. All patients will receive lenalidomide per oral daily (starting dose is 25 mg/d). Cohorts of 3 patients (to be expanded up to 6 if 1 dose-limiting toxicity (DLT) is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide-related toxicity or lenalidomide related serious adverse reactions encountered in the first cycle. For the purpose of this study, patients' enrollment will continue until the maximum tolerated dose (MTD) will be determined and characterized.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- lenalidomide
- Keywords
- AML, lenalidomide
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Dose escalation:
Level 0 to level 5, starting with level 1 = 25mg lenalidomide per os daily, Cohorts of 3 patients (to be expanded up to 6 if 1 DLT is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide related toxicity encountered in the first cycle or lenalidomide related serious adverse reactions.
Duration of the first cycle: 56days, each following cycle will last 28 days
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Not described Receives: Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLTs), Maximum tolerated dose (MTD)
Measured: 1-56 days
Secondary outcomes (2)
Measurement of the pharmacokinetic profile of lenalidomide
Measured: 1st and 8th day
Objective tumor response, as defined using the revised recommendations of the International Working Group for diagnosis, standardization of response criteria in Acute Myeloid Leukemia for AML
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Results of an interim analysis and a hardly ongoing enrolment in the last 10 months in all six participating centres
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Investigators
- Richard Schlenk, MD, Principal investigator, University Hospital of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839059
- Sponsor's protocol ID
- AMLSG08-07
- Status last verified
- Jul 2011
- First submitted
- 20 Jan 2009
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multi-Center Phase I Dose-Escalation Study With Lenalidomide In Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00839059
- Acronym / sponsor ID
- AMLSG08-07
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, lenalidomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of an interim analysis and a hardly ongoing enrolment in the last 10 months in all six participating centres
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Feb 2009 (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.
This is a Phase I, open-label, multi-center, dose-escalation study of lenalidomide in adult patients with newly diagnosed, relapsed or refractory acute myeloid leukemia. All patients will receive lenalidomide per oral daily (starting dose is 25 mg/d). Cohorts of 3 patients (to be expanded up to 6 if 1 dose-limiting toxicity (DLT) is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide-related toxicity or lenalidomide related serious adverse reactions encountered in the first cycle. For the purpose of this study, patients' enrollment will continue until the maximum tolerated dose (MTD) will be determined and characterized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 70 years newly diagnosed AML (including de novo, s-AML, t-AML)considered ineligible for intensive treatment. Ineligibility for intensive treatment has to be documented within the case report forms (Medical/Oncologic History).
- Age > 60 years relapsed/refractory AML in medically fit patients and newly diagnosed AML (including de novo, s- AML,t-AML) in medically unfit patients
- Age 18-60 years: second or higher relapse of AML, not eligible for intensive therapy
- WBC <20x109/l, pretreatment with hydroxyurea is allowed to lower WBC
- Prior chemo-immunotherapy and other study-medications must have been completed 2 weeks before study treatment start. Treatment with hydroxyureas should be discontinued 1 day before initiating dosing with lenalidomide
Key exclusion criteria (17 listed)
- Acute promyelocytic leukemia [t(15;17)]
- bleeding disorder independent of the AML
- uncontrolled infection
- insufficiency of the kidneys (creatinin >1.5x upper normal serum level), of the liver (bilirubin, AST or AP > 2x upper normal serum level)
- severe obstructive or restrictive ventilation disorder
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 |
|---|---|---|
| lenalidomideDose escalation: Level 0 to level 5, starting with level 1 = 25mg lenalidomide per os daily, Cohorts of 3 patients (to be expanded up to 6 if 1 DLT is observed among the first 3 patients) will be sequentially allotted to progressively higher dose levels of lenalidomide on the basis of the presence and severity of lenalidomide related toxicity encountered in the first cycle or lenalidomide related serious adverse reactions. Duration of the first cycle: 56days, each following cycle will last 28 days | Drug | Lenalidomide |
Primary outcome
Dose-Limiting Toxicities (DLTs), Maximum tolerated dose (MTD)
Time frame: 1-56 days
2 secondary outcomes
Measurement of the pharmacokinetic profile of lenalidomide
Time frame: 1st and 8th day
Objective tumor response, as defined using the revised recommendations of the International Working Group for diagnosis, standardization of response criteria in Acute Myeloid Leukemia for AML
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Results of an interim analysis and a hardly ongoing enrolment in the last 10 months in all six participating centres). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
- Related InfoLink provided by the sponsor.
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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.
Richard Schlenk, MD principal investigator
University Hospital of Ulm
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lenalidomide in people with Acute Myeloid Leukemia, run by University of Ulm at 6 sites 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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Results of an interim analysis and a hardly ongoing enrolment in the last 10 months in all six participating centres). 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.
What does the primary outcome measure?
Dose-Limiting Toxicities (DLTs), Maximum tolerated dose (MTD) (time frame: 1-56 days). 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 29 Jul 2011.