Chronic Myelomonocytic LeukemiaPhase 1/2NCT01368757
Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
A Phase 1/2 study testing Revlimid in people with Chronic Myelomonocytic Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 10 sites in Austria.
Trial summary
In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelomonocytic Leukemia
- What is being tested?
- Revlimid
- How many people
- 30 participants
- Where
- 10 sitesAustria
- Study dates
- Jun 2010to May 2015
- Phase
- Phase 1/2
- 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
- CMML according to the WHO diagnostic criteria.
- Understand and voluntarily sign an informed consent form.
- Age >=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. Patients carrying a somatic mutation involving the platelet derived growth factor receptor beta (PDGFRB) can be included if standard treatment with imatinib failed.
- ECOG performance status of <= 2 at study entry.
Show all 19Show fewer
- Laboratory test results within these ranges:
- Creatinine clearance > 30ml/min
- AST (SGOT) and ALT (SGPT) <= 2.5 x ULN
- Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
- Female subjects of childbearing potential must:
- Understand the study drug is expected to have a teratogenic risk
- Agree to use two effective contraception
- Male subjects must
- Agree to use condoms
- Agree not to donate semen
- All subjects must
- Agree to abstain from donating blood
- Agree not to share study drug with another person
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Show all 9Show fewer
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type A, B or C.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Austria10 sites
LKH Feldkirch, Interne E
Feldkirch, Vorarlberg, 6807
Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie
Graz, Styria, 8036
Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie
Innsbruck, Tyrol, 6020
Krankenhaus d. Barmherzigen Schwestern Linz, Interne I
Linz, Upper Austria, 4010
Krankenhaus der Elisabethinen Linz GmbH, 1. Interne
Linz, Upper Austria, 4010
AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie
Linz, Upper Austria, 4021
Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III
Salzburg, State of Salzburg, 5020
MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie
Vienna, State of Vienna, 1090
Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie
Vienna, State of Vienna, 1140
Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung
Wels, Upper Austria, 4600
About this study
Official title: A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. The primary endpoint will concern the efficacy of lenalidomide in patients with CMML according to the WHO diagnostic criteria.
- Conditions
- Chronic Myelomonocytic Leukemia
- Being tested
- Revlimid
- Keywords
- Chronic myelomonocytic leukemia, CMML, Lenalidomide, Revlimid
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevlimidDrug
Also called lenalidomide, lenalidomid
Dose escalation 5mg - 10mg - 15mg - 20mg in cohorts of three patients
The first step of phase I will be 5 mg lenalidomide in a daily regimen, the next step will be 10 mg in a daily regimen, the dosis of the following steps will be increased by 5 mg each until dose limiting toxicity (DLT) is reached.
Phase II will be started at the MTD (1 dose step below DLT) and will be administered in a daily regimen.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
This is a phase I/II, open-label, dose-escalation study of lenalidomide in patients with CMML. In phase I of the study the primary purpose is to determine the MTD. The purpose of phase II is to determine the response rate.
Measured: 2 years
Secondary outcomes (4)
Number and seriousness of adverse events to evaluate safety and tolerability
For both phases (phase I and II), secondary objectives are to evaluate safety, tolerability, efficacy and analysis of molecular markers.
Measured: 4 years
Number of patients achieving transfusion independence
Phase II
Measured: 4 years
Progression free survival, Overall survival
Phase II
Measured: 4 years
Patients achieving cytogenetic response
Phase II; Cytogenetic response assessment requires 20 analyzable metaphases using conventional cytogenetic techniques, FISH may be used an a supplement to follow a specifically defined cytogenetic abnormality
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelomonocytic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- Josef Thaler, MD, Study director, Klinikum Wels-Grieskirchen GmbHSonja Burgstaller, MD, Study director, Klinikum Wels-Grieskirchen GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368757
- Sponsor's protocol ID
- AGMT_CMML 1
- Other IDs
- 2009-017147-33, 2009
- Status last verified
- Mar 2015
- First submitted
- 9 May 2011
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
- ClinicalTrials.gov ID
- NCT01368757
- Acronym / sponsor ID
- AGMT_CMML 1
- Conditions
- Chronic Myelomonocytic Leukemia
- Keywords
- Chronic myelomonocytic leukemia, CMML, Lenalidomide, Revlimid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jun 2010
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 8 Jun 2011 (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.
In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. The primary endpoint will concern the efficacy of lenalidomide in patients with CMML according to the WHO diagnostic criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (19 listed)
- CMML according to the WHO diagnostic criteria.
- Understand and voluntarily sign an informed consent form.
- Age >=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. Patients carrying a somatic mutation involving the platelet derived growth factor receptor beta (PDGFRB) can be included if standard treatment with imatinib failed.
Key exclusion criteria (9 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
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 |
|---|---|---|
| RevlimidAlso: lenalidomide, lenalidomidDose escalation 5mg - 10mg - 15mg - 20mg in cohorts of three patients The first step of phase I will be 5 mg lenalidomide in a daily regimen, the next step will be 10 mg in a daily regimen, the dosis of the following steps will be increased by 5 mg each until dose limiting toxicity (DLT) is reached. Phase II will be started at the MTD (1 dose step below DLT) and will be administered in a daily regimen. | Drug | – |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 2 years
This is a phase I/II, open-label, dose-escalation study of lenalidomide in patients with CMML. In phase I of the study the primary purpose is to determine the MTD. The purpose of phase II is to determine the response rate.
4 secondary outcomes
Number and seriousness of adverse events to evaluate safety and tolerability
Time frame: 4 years
Number of patients achieving transfusion independence
Time frame: 4 years
Progression free survival, Overall survival
Time frame: 4 years
Patients achieving cytogenetic response
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
Related trials for Chronic Myelomonocytic Leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
Active, not recruitingPhase 2
Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
Juvenile Myelomonocytic Leukemia, Neurofibromatosis Type 1
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
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.
Josef Thaler, MD study director
Klinikum Wels-Grieskirchen GmbH
Sonja Burgstaller, MD study director
Klinikum Wels-Grieskirchen GmbH
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Revlimid in people with Chronic Myelomonocytic Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 10 sites in Austria.
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 19 inclusion and 9 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Austria. 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 combined 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.
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.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: 2 years). 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 9 Mar 2015.