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Efficacy of Eltrombopag Plus Lenalidomide Combination Therapy in Patients With IPSS Low and Intermediate-risk Myelodysplastic Syndrome With Isolated del5q

Primary Purpose

Myelodysplastic Syndromes

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Eltrombopag/Revolade
Placebo
Lenalidomide
Sponsored by
Associazione Qol-one
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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:

    1. 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.
    2. 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:

    1. Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during lactation does not rule out childbearing potential).
    2. Premature ovarian failure confirmed by a gynaecologist
    3. Previous bilateral salpingo-oophorectomy, or hysterectomy
    4. 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.

Exclusion Criteria:

  • 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.
  • 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).

Sites / Locations

  • CHU d'Angers
  • Centre Henri Mondor
  • CHU de Grenoble
  • Centre Le Mans
  • CHRU de Limoges
  • Centre Hospitalier Lyon Sud
  • Centre de Marseille
  • CHU Brabois
  • Centre de Nantes
  • Hopital Archet 1
  • Centre Hospitalier Universitaire de Nimes
  • Centre de Rouen, Centre Henri Becquerel
  • CHU Purpan
  • CHU de Bretonneau
  • "G.Gennimatas" General Hospital of Athens
  • University Hospital "Atticon",
  • University Hospital "Laikon"
  • University Hospital of Crete
  • University Hospital of Larissa
  • University Hospital of Patras
  • "George Papanicolaou General Hospital of Thessaloniki
  • A.O. SS. Antonio e Biagio e Cesare Arrigo
  • Ospedale Riuniti
  • Ospedale Cardinal Massaia
  • A.O. S. Giovanni Moscati
  • Presidio Ospedaliero Oncologico Businco
  • Ospedale L'Annunziata
  • Ospedale Ferrarotto
  • Ospedale Garibaldi
  • Ospedale Casa Sollievo della Sofferenza
  • Azienda Ospedaliera Universitaria Careggi
  • Ospedale Vito Fazzi
  • A.O. San Gerardo
  • IRCCS Ospedale Maggiore Policlinico
  • Ospedale Niguarda
  • Ospedale Civile Spirito Santo
  • Azienda Ospedaliera Bianchi-Melacrino-Morelli
  • Arcispedale di Santa Maria Nuova
  • A.O. San Camillo Forlanini
  • Ospedale Sant'Eugenio
  • Policlinico Agostino Gemelli
  • Azienda Ospedaliera Sant'Andrea
  • IRCCS Istituto Regina Elena
  • Ospedale Nuova Regina Margherita
  • Policlinico Umberto I
  • Policlinico Universitario Tor Vergata
  • Policlinico Santa Maria alle Scotte
  • A.O. Santa Maria
  • A.O. Citta' della Salute e della Scienza di Torino
  • U.O. Citta' della Salute e della Scienza di Torino

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1 (Eltrombopag)

Arm 2 (Placebo)

Arm Description

Arm 1 is the active treatment arm

Arm 2 is the control arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response (patients number with composite endpoint experience on long-term)
The composite endpoint during the entire study period
Safety (number of adverse events)
Safety and tolerability in terms of frequency of adverse events (AE)s and serious adverse events (SAE).
Cytogenetic responses
Proportion of cytogenetic responses, according to IWG 2006 criteria
Duration of cytogenetic response
Duration of cytogenetic response
Hb changes
Hb changes within the first 24 weeks.
Erythroid response
Erythroid response, transfusion-independence (TI) and duration of TI.
Quality of Life (QOL)
Changes in QOL scores
Progression free survival
Progression free survival from baseline
Overall survival
Overall survival from baseline

Full Information

First Posted
October 5, 2016
Last Updated
September 21, 2018
Sponsor
Associazione Qol-one
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1. Study Identification

Unique Protocol Identification Number
NCT02928419
Brief Title
Efficacy of Eltrombopag Plus Lenalidomide Combination Therapy in Patients With IPSS Low and Intermediate-risk Myelodysplastic Syndrome With Isolated del5q
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
"the study has been closed due to a low rate of patient enrollment (2 patients since the start of the trial)"
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Associazione Qol-one

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (Eltrombopag)
Arm Type
Experimental
Arm Description
Arm 1 is the active treatment arm
Arm Title
Arm 2 (Placebo)
Arm Type
Placebo Comparator
Arm Description
Arm 2 is the control arm
Intervention Type
Drug
Intervention Name(s)
Eltrombopag/Revolade
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
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
Primary Outcome Measure Information:
Title
Response (patients number with composite endpoint experience)
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Response (patients number with composite endpoint experience on long-term)
Description
The composite endpoint during the entire study period
Time Frame
36 months
Title
Safety (number of adverse events)
Description
Safety and tolerability in terms of frequency of adverse events (AE)s and serious adverse events (SAE).
Time Frame
36 months
Title
Cytogenetic responses
Description
Proportion of cytogenetic responses, according to IWG 2006 criteria
Time Frame
36 months
Title
Duration of cytogenetic response
Description
Duration of cytogenetic response
Time Frame
36 months
Title
Hb changes
Description
Hb changes within the first 24 weeks.
Time Frame
24 weeks
Title
Erythroid response
Description
Erythroid response, transfusion-independence (TI) and duration of TI.
Time Frame
36 months
Title
Quality of Life (QOL)
Description
Changes in QOL scores
Time Frame
36 months
Title
Progression free survival
Description
Progression free survival from baseline
Time Frame
36 months
Title
Overall survival
Description
Overall survival from baseline
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Natalie Oliva, MD
Organizational Affiliation
QOL-ONE Associazione Culturale e di Ricerca
Official's Role
Study Chair
Facility Information:
Facility Name
CHU d'Angers
City
Angers
Country
France
Facility Name
Centre Henri Mondor
City
Creteil
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
Centre Le Mans
City
Le Mans
Country
France
Facility Name
CHRU de Limoges
City
Limoges
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
Country
France
Facility Name
Centre de Marseille
City
Marseille
Country
France
Facility Name
CHU Brabois
City
Nancy
Country
France
Facility Name
Centre de Nantes
City
Nantes
Country
France
Facility Name
Hopital Archet 1
City
Nice
Country
France
Facility Name
Centre Hospitalier Universitaire de Nimes
City
Nimes
Country
France
Facility Name
Centre de Rouen, Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
CHU Purpan
City
Toulouse
Country
France
Facility Name
CHU de Bretonneau
City
Tours
Country
France
Facility Name
"G.Gennimatas" General Hospital of Athens
City
Athens
Country
Greece
Facility Name
University Hospital "Atticon",
City
Athens
Country
Greece
Facility Name
University Hospital "Laikon"
City
Athens
Country
Greece
Facility Name
University Hospital of Crete
City
Crete
Country
Greece
Facility Name
University Hospital of Larissa
City
Larissa
Country
Greece
Facility Name
University Hospital of Patras
City
Patras
Country
Greece
Facility Name
"George Papanicolaou General Hospital of Thessaloniki
City
Thessaloniki
Country
Greece
Facility Name
A.O. SS. Antonio e Biagio e Cesare Arrigo
City
Alessandria
State/Province
AL
Country
Italy
Facility Name
Ospedale Riuniti
City
Ancona
State/Province
AN
Country
Italy
Facility Name
Ospedale Cardinal Massaia
City
Asti
State/Province
AT
Country
Italy
Facility Name
A.O. S. Giovanni Moscati
City
Avellino
State/Province
AV
Country
Italy
Facility Name
Presidio Ospedaliero Oncologico Businco
City
Cagliari
State/Province
CA
Country
Italy
Facility Name
Ospedale L'Annunziata
City
Cosenza
State/Province
CS
Country
Italy
Facility Name
Ospedale Ferrarotto
City
Catania
State/Province
CT
Country
Italy
Facility Name
Ospedale Garibaldi
City
Catania
State/Province
CT
Country
Italy
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
FG
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
State/Province
FI
Country
Italy
Facility Name
Ospedale Vito Fazzi
City
Lecce
State/Province
LE
Country
Italy
Facility Name
A.O. San Gerardo
City
Monza
State/Province
MB
Country
Italy
Facility Name
IRCCS Ospedale Maggiore Policlinico
City
Milano
State/Province
MI
Country
Italy
Facility Name
Ospedale Niguarda
City
Milano
State/Province
MI
Country
Italy
Facility Name
Ospedale Civile Spirito Santo
City
Pescara
State/Province
PE
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi-Melacrino-Morelli
City
Reggio Calabria
State/Province
RC
ZIP/Postal Code
89100
Country
Italy
Facility Name
Arcispedale di Santa Maria Nuova
City
Reggio Emilia
State/Province
RE
Country
Italy
Facility Name
A.O. San Camillo Forlanini
City
Roma
State/Province
RM
Country
Italy
Facility Name
Ospedale Sant'Eugenio
City
Roma
State/Province
RM
Country
Italy
Facility Name
Policlinico Agostino Gemelli
City
Roma
State/Province
RM
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Rome
State/Province
RM
Country
Italy
Facility Name
IRCCS Istituto Regina Elena
City
Rome
State/Province
RM
Country
Italy
Facility Name
Ospedale Nuova Regina Margherita
City
Rome
State/Province
RM
Country
Italy
Facility Name
Policlinico Umberto I
City
Rome
State/Province
RM
Country
Italy
Facility Name
Policlinico Universitario Tor Vergata
City
Rome
State/Province
RM
Country
Italy
Facility Name
Policlinico Santa Maria alle Scotte
City
Siena
State/Province
SI
Country
Italy
Facility Name
A.O. Santa Maria
City
Terni
State/Province
TE
Country
Italy
Facility Name
A.O. Citta' della Salute e della Scienza di Torino
City
Torino
State/Province
TO
Country
Italy
Facility Name
U.O. Citta' della Salute e della Scienza di Torino
City
Torino
State/Province
TO
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Efficacy of Eltrombopag Plus Lenalidomide Combination Therapy in Patients With IPSS Low and Intermediate-risk Myelodysplastic Syndrome With Isolated del5q

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