Myelodysplastic SyndromePhase 2ViLen 001NCT01053806
Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome
A Phase 2 study testing 5-Azacytidine and Lenalidomide in people with Myelodysplastic Syndrome, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1 who are considered to be at high risk due to unfavorable additional factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- 5-Azacytidine and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Mar 2014
- 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
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Patient is older than 18 years at the time of signing the informed consent.
- Female subjects of childbearing potential† must:
- Understand that the study medication could have a potential teratogenic risk (Lenalidomide is structurally related to thalidomide which is a known human teratogenic active substance that causes severe life-threatening birth defects. Lenalidomide induced in monkeys malformations similar to those described with thalidomide)
- Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception • Implant - Levonorgestrel-releasing intrauterine system (IUS)
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- Medroxyprogesterone acetate depot • Tubal sterilisation • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses • Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.
- prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
- o Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
- Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
- Male subjects must Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- All subjects must Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- Agree not to share study medication with another person and to return all unused study drug to the investigator
- Patient was diagnosed with Myelodysplastic syndrome, INT-2 or HIGH risk according IPSS score, Low risk and INT-1 risk patients that meet all of the following criteria may also be included into the trial when they meet the following criteria:
- Resistant to EPO
- No transfusion independence achieved with lenalidomide treatment alone
- RBC transfusion dependant
- cytogenetic abnormalities: del 5q, chromosome 7, 5q with complex karyotypes
- Bone marrow aspiration examination including cytogenetics performed up to 12 months before patient signing informed consent.
- Patient was defined as erythropoietin resistant (not increasing Hb level after 8 weeks of erythropoietin treatment in the past or is not planed to receive erythropoietin in study period.)
- Patient has a Performance status 0-2 (WHO).(see appendix V)
- Patient has a life-expectancy > 6 months
- Patient has negative serology for: active infectious hepatitis type B or C, or HIV infection.
- Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1):
- Platelet count ≥ 25 x 109/L without transfusion support within 7 days before the test.
- Absolute neutrophil count (ANC) ≥ 0.5 x 109/L without the use of growth factors.
- Aspartate transaminase (AST): ≤2.5 x the upper limit of normal (ULN).
- Alanine transaminase (ALT): ≤ 2.5 x the ULN.
- Total bilirubin: ≤ 1.5 x the ULN.
- serum creatinine: ≤ 2 X the ULN
Who cannot join
- Previous treatment with anti-MDS therapy in the last 2 months (including growth factors, does not include blood transfusions).
- Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- Pregnant or lactating females.
- Prior history of malignancies, other than MDS, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- Patients previously diagnosed as bearing deep venous thrombosis or arterial thromboembolic event within the latest 6 months, or bearing a clear contra indication for anti-platelet or anticoagulant therapy or bearing a high risk of bleeding complications are ineligible for the study protocol.
- Bone marrow blast count > 30%
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- low risk MDS according IPSS with no additional features appearing in inclusion criteria number 5
- Total bilirubin > 1.5 x ULN
- AST/ALT > 2.5 x ULN
- Serum creatinine > 2 x ULN
- Known allergy or intolerance to Lenalidomide or 5-azacitatidine or any of the exipients
- Use of chemotherapeutic drugs or biologic agents or steroids in the last 3 months.
- Administration of investigational drugs in the last 3 month
- Known neuropathy
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of internal medicine A
Tel Aviv
Moshe Mittelman, Prof, moshemt@tasmc.health.gov.il
Moshe Mittelman, Prof
About this study
Official title: A PHASE 2, SINGLE ARM STUDY TO DETERMINE THE SAFETY AND EFFICACY OF AZACITIDINE, AND LENALIDOMIDE IN HIGHER RISK MYELODYSPLASTIC SYNDROME
To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1 who are considered to be at high risk due to unfavorable additional factors.
- To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients.
- To evaluate the hematological improvement rate.
- To evaluate the cytogenetic response rate.
- To evaluate the Progression free survival (PFS).
- To assess Quality of life.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- 5-Azacytidine and Lenalidomide
- Keywords
- MDS, Lenalidomide, 5-Azacytidine., ORR, PFS, myelodysplastic syndrome.High risk.
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Azacytidine and LenalidomideDrug
Induction:5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days a cycle for 6 cycles and Lenalidomide 10mg/d orally days 6-28 every cycle for 6 cycles Consolidation: 5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days for 6 cycles Maintenance: Lenalidomide 10mg/d orally days 1-21 every cycle of 28 days for 13 cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: 2 years
Secondary outcomes (1)
PFS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startAug 2011
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053806
- Sponsor's protocol ID
- TASMC-10-MM-0437-09-CTIL
- Acronym
- ViLen 001
- Status last verified
- Sep 2012
- First submitted
- 19 Jan 2010
- Last updated
- 25 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 2, SINGLE ARM STUDY TO DETERMINE THE SAFETY AND EFFICACY OF AZACITIDINE, AND LENALIDOMIDE IN HIGHER RISK MYELODYSPLASTIC SYNDROME
- ClinicalTrials.gov ID
- NCT01053806
- Acronym / sponsor ID
- ViLen 001 / TASMC-10-MM-0437-09-CTIL
- Conditions
- Myelodysplastic Syndrome
- Keywords
- MDS, Lenalidomide, 5-Azacytidine., ORR, PFS, myelodysplastic syndrome.High risk.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (estimated)
- First posted
- 21 Jan 2010 (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.
To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1 who are considered to be at high risk due to unfavorable additional factors.
- To evaluate the safety of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients.
- To evaluate the hematological improvement rate.
- To evaluate the cytogenetic response rate.
- To evaluate the Progression free survival (PFS).
- To assess Quality of life.
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 (32 listed)
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Patient is older than 18 years at the time of signing the informed consent.
- Female subjects of childbearing potential† must:
- Understand that the study medication could have a potential teratogenic risk (Lenalidomide is structurally related to thalidomide which is a known human teratogenic active substance that causes severe life-threatening birth defects. Lenalidomide induced in monkeys malformations similar to those described with thalidomide)
Key exclusion criteria (15 listed)
- Previous treatment with anti-MDS therapy in the last 2 months (including growth factors, does not include blood transfusions).
- Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
- Pregnant or lactating females.
- Prior history of malignancies, other than MDS, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- Patients previously diagnosed as bearing deep venous thrombosis or arterial thromboembolic event within the latest 6 months, or bearing a clear contra indication for anti-platelet or anticoagulant therapy or bearing a high risk of bleeding complications are ineligible for the study protocol.
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 |
|---|---|---|
| 5-Azacytidine and LenalidomideInduction:5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days a cycle for 6 cycles and Lenalidomide 10mg/d orally days 6-28 every cycle for 6 cycles Consolidation: 5-Azacytidine 75mg/m2/d S.C.or I.V. days 1-5 every 28 days for 6 cycles Maintenance: Lenalidomide 10mg/d orally days 1-21 every cycle of 28 days for 13 cycles. | Drug | – |
Primary outcome
ORR
Time frame: 2 years
1 secondary outcome
PFS
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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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.
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 5-Azacytidine and Lenalidomide in people with Myelodysplastic Syndrome, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 32 inclusion and 15 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 25 Sep 2012. 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 Israel. 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 Moshe Mittelman, prof (+972-524266736, moshemt@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (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 25 Sep 2012.