Myelodysplastic SyndromesPhase 2NCT02928419
Efficacy of Eltrombopag Plus Lenalidomide Combination Therapy in Patients With IPSS Low and Intermediate-risk Myelodysplastic Syndrome With Isolated del5q
A Phase 2 study testing Eltrombopag/Revolade and Lenalidomide in people with Myelodysplastic Syndromes, run by Associazione Qol-one at 50 sites in 3 countries.
Trial summary
Myelodysplastic syndromes (MDS) prevail in elderly patients and are characterized by inefficient erythropoiesis and peripheral cytopenias. Supportive care still represents the main therapeutic option in most patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Eltrombopag/Revolade and Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 50 sitesin 3 countries
- Study dates
- May 2015to Sep 2018
- 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
- Adult subjects (18 years of age or older) with MDS and low or intermediate-1 IPSS risk and del5q as a single abnormality, at the time of their screening and enrollment into the study
- Subjects must not have received any prior treatment course with any immunomodulating agent nor TPO-R agonists
- Subjects must be dependent on regular packed RBC transfusions, as defined by international working group 2006 criteria, and must have a PLT count taken within the 4 weeks prior to screening that is >25 Gi/L.
- Absolute Neutrophil Counts (ANC) ≥ 0.5 GiL
- Resistant or refractory to erythropoetic stimulating agents (ESAs) and/or serum erythropoetin levels > 500 miU/L
- Subjects must be ineligible or relapsed or refractory to receive treatment options of azacitidine and decitabine.
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- Subjects must have PLT count and RBC and PLT transfusion data available over a period of 8 weeks prior to screening.
- During the 2 months prior to randomization, subjects must have a baseline BM examination including all of the following: cytomorphology, cytogenetics and histology
- ECOG Performance Status must be 0-3.
- The following clinical chemistries MUST NOT exceed the upper limit of normal (ULN) reference range: creatinine, ALT, AST, total bilirubin (except for Gilbert's Syndrome), gamma-gt and alkaline phosphatase. In addition, albumin must not be below the lower limit of normal (LLN) by more than 10%.
- If subject meets the criteria for childbearing potential:
- Negative pregnancy test in female subjects within the 3 days prior to Day 1 of 1st cycle and effective contraception for at least 4 weeks.
- Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal >1 year), or of childbearing potential and use of an highly effective method of contraception from 2 weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study.
- Criteria for women of non-childbearing potential: A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
- Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during lactation does not rule out childbearing potential).
- Premature ovarian failure confirmed by a gynaecologist
- Previous bilateral salpingo-oophorectomy, or hysterectomy
- XY genotype, Turner syndrome, uterine agenesis.
- Subject is able to understand and comply with protocol requirements and instructions.
- Subject has signed and dated informed consent.
Who cannot join
- MDS with intermediate-2 or high IPSS risk
- Additional cytogenetic abnormalities
- Transfusion independence (TI) by IWG 2006 criteria
- Absolute Neutrophil Count < 0.5 Gi/L and/or Platelet counts < 25 Gi/L
- History of treatment for cancer with systemic chemotherapy and/or radiotherapy within the last 2 years
- History of treatment with immunomodulatory drugs or other TPO-R agonists.
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- Thrombophilia, pre-existing history of thrombosis, cardiovascular disease (including congestive heart failure, New York Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc >450 msec (QTc >480 msec for subjects with Bundle Branch Block)
- Bone Marrow fibrosis that leads to an inability to aspirate marrow for assessment.
- Leukocytosis >=25,000/uL prior to Day 1 of study medication.
- Monocytosis > 1000/ uL prior to Day 1 of study medication.
- Female subjects who are nursing or pregnant (positive serum or urine Beta-human chorionic gonadotropin [B-hCG] pregnancy test).
- Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme illustrated in sections 6.4 are met (see sections 6.4).
- Known hypersensitivity to lenalidomide.
- Current alcohol or drug abuse.
- Treatment with an Investigational Product within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- Active and uncontrolled infections.
- Subjects infected with Hepatitis B, C or Human Immunodeficiency Virus (HIV).
Trial locations and contacts
50 sites in 3 countries.
50 sites in 3 countries
Italy29 sites
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, AL
Ospedale Riuniti
Ancona, AN
Ospedale Cardinal Massaia
Asti, AT
A.O. S. Giovanni Moscati
Avellino, AV
Presidio Ospedaliero Oncologico Businco
Cagliari, CA
Ospedale Ferrarotto
Catania, CT
Ospedale Garibaldi
Catania, CT
Ospedale L'Annunziata
Cosenza, CS
Azienda Ospedaliera Universitaria Careggi
Florence, FI
Ospedale Vito Fazzi
Lecce, LE
IRCCS Ospedale Maggiore Policlinico
Milan, MI
Ospedale Niguarda
Milan, MI
A.O. San Gerardo
Monza, MB
Ospedale Civile Spirito Santo
Pescara, PE
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, RC, 89100
Arcispedale di Santa Maria Nuova
Reggio Emilia, RE
A.O. San Camillo Forlanini
Roma, RM
Ospedale Sant'Eugenio
Roma, RM
Policlinico Agostino Gemelli
Roma, RM
Azienda Ospedaliera Sant'Andrea
Rome, RM
IRCCS Istituto Regina Elena
Rome, RM
Ospedale Nuova Regina Margherita
Rome, RM
Policlinico Umberto I
Rome, RM
Policlinico Universitario Tor Vergata
Rome, RM
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG
Policlinico Santa Maria alle Scotte
Siena, SI
A.O. Santa Maria
Terni, TE
A.O. Citta' della Salute e della Scienza di Torino
Torino, TO
U.O. Citta' della Salute e della Scienza di Torino
Torino, TO
France14 sites
CHU d'Angers
Angers
Centre Henri Mondor
Créteil
CHU de Grenoble
Grenoble
Centre Le Mans
Le Mans
CHRU de Limoges
Limoges
Centre Hospitalier Lyon Sud
Lyon
Centre de Marseille
Marseille
CHU Brabois
Nancy
Centre de Nantes
Nantes
Hopital Archet 1
Nice
Centre Hospitalier Universitaire de Nimes
Nîmes
Centre de Rouen, Centre Henri Becquerel
Rouen
CHU Purpan
Toulouse
CHU de Bretonneau
Tours
Greece7 sites
"G.Gennimatas" General Hospital of Athens
Athens
University Hospital "Atticon",
Athens
University Hospital "Laikon"
Athens
University Hospital of Crete
Crete
University Hospital of Larissa
Larissa
University Hospital of Patras
Pátrai
"George Papanicolaou General Hospital of Thessaloniki
Thessaloniki
About this study
Official title: Efficacy of Eltrombopag Plus Lenalidomide Combination Therapy in Patients With IPSS Low and Intermediate-risk Myelodysplastic Syndrome With Isolated del5q: a Multicenter, Randomized, Double-blind, Placebo Controlled Study - QOL-ONE Rev2MDS
Myelodysplastic syndromes (MDS) prevail in elderly patients and are characterized by inefficient erythropoiesis and peripheral cytopenias. Supportive care still represents the main therapeutic option in most patients. Quality of life is deteriorated mostly by anemia and by limitations due to dependence on transfusions, thrombocytopenia, and neutropenia. The only treatment available for severe thrombocytopenia consists of PLT transfusions, mainly in the presence of bleeding.
In patients with low and intermediate-1 risk MDS with an isolated deletion 5q cytogenetic abnormality, red blood cell (RBC) transfusion-dependence is a prevalent condition. For these latter patients reaching transfusion-dependence, lenalidomide, an immunomodulatory drug, has been approved by FDA and EMA. It has been shown that the drug induces significant erythroid (about 65%) and cytogenetic responses which have been associated with a survival benefit. In patients with MDS with del5q and serum erythropoietin levels > 500 miU/L, lenalidomide dosing of 10 mg/day for 21 days every 28, rather than 5 mg dosing, induces higher rates of transfusion-independence and cytogenetic responses with a trend to survival advantage. As a consequence, the recommended starting dose of lenalidomide is 10 mg orally once daily on days 1-21 of repeated 28-day cycles. Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) < 0.5 Gi/L and/or PLT counts < 25 Gi/L.
Read more
For patients who are dosed initially at 10 mg and who experience thrombocytopenia < 25 Gi/L (45-75%), it is recommended to interrupt lenalidomide treatment until PLT count returns to ≥ 25 Gi/L on at least 2 occasions for ≥ 7 days or when the PLT count recovers to ≥ 50 Gi/L at any time, to resume lenalidomide at 50% dose reduction.
Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. It has been shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic colonies. These results provide the rationale for pursuing further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS.
Preliminary results of an ongoing randomized trial, EQoL-MDS, for the evaluation of efficacy, safety of eltrombopag for thrombocytopenia of low and intermediate-1 IPSS risk MDS has shown that eltrombopag is able to significantly raise PLT counts in about 65% of patients without additional toxicity Furthermore, the combination of lenalidomide and eltrombopag resulted in significant inhibitory effects on the growth of leukemic colonies in the majority of primary MDS and AML samples. Most importantly, eltrombopag was able to reverse the anti-megakaryopoietic effects of lenalidomide in primary MDS patient samples. These results provide a preclinical rationale for the use of this combination in MDS and AML
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Eltrombopag/Revolade, Placebo, Lenalidomide
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eltrombopag/RevoladeDrug
From day 1, patients presenting with PLT counts ≤ 100 Gi/L at any time will receive oral eltrombopag for a maximum of 36 months.
Starting dose will depend on PLT count determined on the day of first dose of eltrombopag. For patients experiencing PLT count 70 to 100 Gi/L, initial dosing is 50 mg/day. For subjects presenting with PLT counts < 70 Gi/L initial dosing is 100 mg/day. The dose of study medication must be increased sequentially by 50 mg every 7 days, up to a maximum dose of 300 mg/day until PLT ≥ 100 Gi/L. For East Asian subjects, a maximum dose of 150 mg is permitted.
PlaceboOther
From day 1, patients presenting with PLT counts ≤ 100 Gi/L at any time will receive oral placebo for a maximum of 36 months.
Starting dose will depend on PLT count determined on the day of first dose of placebo. For patients experiencing PLT count 70 to 100 Gi/L, initial dosing is 50 mg/day. For subjects presenting with PLT counts < 70 Gi/L initial dosing is 100 mg/day. The dose of study medication must be increased sequentially by 50 mg every 7 days, up to a maximum dose of 300 mg/day until PLT ≥ 100 Gi/L. For East Asian subjects, a maximum dose of 150 mg is permitted.
LenalidomideDrug
All patients will receive oral lenalidomide 10 mg/day for 21 days every 28 days. Patients will receive lenalidomide dosing according to the lenalidomide product information. Patients obtaining an erythroid response according to IWG 2006 criteria within the first 24 weeks will continue lenalidomide treatment until progression or other reasons for permanent discontinuation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Eltrombopag) | Experimental | Arm 1 is the active treatment arm Receives: Drug: Eltrombopag/Revolade; Drug: Lenalidomide |
| Arm 2 (Placebo) | Placebo comparator | Arm 2 is the control arm Receives: Other: Placebo; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response (patients number with composite endpoint experience)
To evaluate the effect of eltrombopag treatment relative to placebo on the incidence of the "composite endpoint" (PLT<25 Gi/L or bleeding event with WHO bleeding score >1 or study discontinuation), in the first 24 weeks, after experiencing PLT<100 Gi/L
Measured: 24 weeks
Secondary outcomes (9)
Response (patients number with composite endpoint experience on long-term)
The composite endpoint during the entire study period
Measured: 36 months
Safety (number of adverse events)
Safety and tolerability in terms of frequency of adverse events (AE)s and serious adverse events (SAE).
Measured: 36 months
Cytogenetic responses
Proportion of cytogenetic responses, according to IWG 2006 criteria
Measured: 36 months
Duration of cytogenetic response
Duration of cytogenetic response
Measured: 36 months
Hb changes
Hb changes within the first 24 weeks.
Measured: 24 weeks
Erythroid response
Erythroid response, transfusion-independence (TI) and duration of TI.
Measured: 36 months
Quality of Life (QOL)
Changes in QOL scores
Measured: 36 months
Progression free survival
Progression free survival from baseline
Measured: 36 months
Overall survival
Overall survival from baseline
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: "the study has been closed due to a low rate of patient enrollment (2 patients since the start of the trial)"
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associazione Qol-one
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Natalie Oliva, MD, Study chair, QOL-ONE Associazione Culturale e di Ricerca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928419
- Sponsor's protocol ID
- QOL-ONE Rev2MDS
- Status last verified
- Sep 2018
- First submitted
- 5 Oct 2016
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Eltrombopag Plus Lenalidomide Combination Therapy in Patients With IPSS Low and Intermediate-risk Myelodysplastic Syndrome With Isolated del5q: a Multicenter, Randomized, Double-blind, Placebo Controlled Study - QOL-ONE Rev2MDS
- ClinicalTrials.gov ID
- NCT02928419
- Acronym / sponsor ID
- QOL-ONE Rev2MDS
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: "the study has been closed due to a low rate of patient enrollment (2 patients since the start of the trial)"
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Associazione Qol-oneUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 10 Oct 2016 (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.
Myelodysplastic syndromes (MDS) prevail in elderly patients and are characterized by inefficient erythropoiesis and peripheral cytopenias. Supportive care still represents the main therapeutic option in most patients. Quality of life is deteriorated mostly by anemia and by limitations due to dependence on transfusions, thrombocytopenia, and neutropenia. The only treatment available for severe thrombocytopenia consists of PLT transfusions, mainly in the presence of bleeding.
In patients with low and intermediate-1 risk MDS with an isolated deletion 5q cytogenetic abnormality, red blood cell (RBC) transfusion-dependence is a prevalent condition. For these latter patients reaching transfusion-dependence, lenalidomide, an immunomodulatory drug, has been approved by FDA and EMA. It has been shown that the drug induces significant erythroid (about 65%) and cytogenetic responses which have been associated with a survival benefit. In patients with MDS with del5q and serum erythropoietin levels > 500 miU/L, lenalidomide dosing of 10 mg/day for 21 days every 28, rather than 5 mg dosing, induces higher rates of transfusion-independence and cytogenetic responses with a trend to survival advantage. As a consequence, the recommended starting dose of lenalidomide is 10 mg orally once daily on days 1-21 of repeated 28-day cycles. Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) < 0.5 Gi/L and/or PLT counts < 25 Gi/L.
For patients who are dosed initially at 10 mg and who experience thrombocytopenia < 25 Gi/L (45-75%), it is recommended to interrupt lenalidomide treatment until PLT count returns to ≥ 25 Gi/L on at least 2 occasions for ≥ 7 days or when the PLT count recovers to ≥ 50 Gi/L at any time, to resume lenalidomide at 50% dose reduction.
Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. It has been shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic colonies. These results provide the rationale for pursuing further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS.
Preliminary results of an ongoing randomized trial, EQoL-MDS, for the evaluation of efficacy, safety of eltrombopag for thrombocytopenia of low and intermediate-1 IPSS risk MDS has shown that eltrombopag is able to significantly raise PLT counts in about 65% of patients without additional toxicity Furthermore, the combination of lenalidomide and eltrombopag resulted in significant inhibitory effects on the growth of leukemic colonies in the majority of primary MDS and AML samples. Most importantly, eltrombopag was able to reverse the anti-megakaryopoietic effects of lenalidomide in primary MDS patient samples. These results provide a preclinical rationale for the use of this combination in MDS and AML
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Eltrombopag) | Experimental | Drug: Eltrombopag/Revolade, Drug: LenalidomideArm 1 is the active treatment arm |
| Arm 2 (Placebo) | Placebo comparator | Other: Placebo, Drug: LenalidomideArm 2 is the control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult subjects (18 years of age or older) with MDS and low or intermediate-1 IPSS risk and del5q as a single abnormality, at the time of their screening and enrollment into the study
- Subjects must not have received any prior treatment course with any immunomodulating agent nor TPO-R agonists
- Subjects must be dependent on regular packed RBC transfusions, as defined by international working group 2006 criteria, and must have a PLT count taken within the 4 weeks prior to screening that is >25 Gi/L.
- Absolute Neutrophil Counts (ANC) ≥ 0.5 GiL
- Resistant or refractory to erythropoetic stimulating agents (ESAs) and/or serum erythropoetin levels > 500 miU/L
Key exclusion criteria (17 listed)
- MDS with intermediate-2 or high IPSS risk
- Additional cytogenetic abnormalities
- Transfusion independence (TI) by IWG 2006 criteria
- Absolute Neutrophil Count < 0.5 Gi/L and/or Platelet counts < 25 Gi/L
- History of treatment for cancer with systemic chemotherapy and/or radiotherapy within the last 2 years
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 |
|---|---|---|
| Eltrombopag/RevoladeFrom day 1, patients presenting with PLT counts ≤ 100 Gi/L at any time will receive oral eltrombopag for a maximum of 36 months. Starting dose will depend on PLT count determined on the day of first dose of eltrombopag. For patients experiencing PLT count 70 to 100 Gi/L, initial dosing is 50 mg/day. For subjects presenting with PLT counts < 70 Gi/L initial dosing is 100 mg/day. The dose of study medication must be increased sequentially by 50 mg every 7 days, up to a maximum dose of 300 mg/day until PLT ≥ 100 Gi/L. For East Asian subjects, a maximum dose of 150 mg is permitted. | Drug | Arm 1 (Eltrombopag) |
| PlaceboFrom day 1, patients presenting with PLT counts ≤ 100 Gi/L at any time will receive oral placebo for a maximum of 36 months. Starting dose will depend on PLT count determined on the day of first dose of placebo. For patients experiencing PLT count 70 to 100 Gi/L, initial dosing is 50 mg/day. For subjects presenting with PLT counts < 70 Gi/L initial dosing is 100 mg/day. The dose of study medication must be increased sequentially by 50 mg every 7 days, up to a maximum dose of 300 mg/day until PLT ≥ 100 Gi/L. For East Asian subjects, a maximum dose of 150 mg is permitted. | Other | Arm 2 (Placebo) |
| LenalidomideAll patients will receive oral lenalidomide 10 mg/day for 21 days every 28 days. Patients will receive lenalidomide dosing according to the lenalidomide product information. Patients obtaining an erythroid response according to IWG 2006 criteria within the first 24 weeks will continue lenalidomide treatment until progression or other reasons for permanent discontinuation | Drug | Arm 1 (Eltrombopag), Arm 2 (Placebo) |
Primary outcome
Response (patients number with composite endpoint experience)
Time frame: 24 weeks
To evaluate the effect of eltrombopag treatment relative to placebo on the incidence of the "composite endpoint" (PLT<25 Gi/L or bleeding event with WHO bleeding score >1 or study discontinuation), in the first 24 weeks, after experiencing PLT<100 Gi/L
9 secondary outcomes
Response (patients number with composite endpoint experience on long-term)
Time frame: 36 months
Safety (number of adverse events)
Time frame: 36 months
Cytogenetic responses
Time frame: 36 months
Duration of cytogenetic response
Time frame: 36 months
Hb changes
Time frame: 24 weeks
Erythroid response
Time frame: 36 months
Quality of Life (QOL)
Time frame: 36 months
Progression free survival
Time frame: 36 months
Overall survival
Time frame: 36 months
Results and safety
The study was stopped early (reason given: "the study has been closed due to a low rate of patient enrollment (2 patients since the start of the trial)"). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Esther Natalie Oliva, MD study chair
QOL-ONE Associazione Culturale e di Ricerca
50 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eltrombopag/Revolade and Lenalidomide in people with Myelodysplastic Syndromes, run by Associazione Qol-one at 50 sites in 3 countries.
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 20 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Italy, France, Greece. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: "the study has been closed due to a low rate of patient enrollment (2 patients since the start of the trial)"). 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?
Response (patients number with composite endpoint experience) (time frame: 24 weeks). 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 2018.