Study of REVLIMID (Lenalidomide) Versus Placebo in Patients With Low Risk Myelodysplastic Syndrome
NCT ID: NCT01243476
Last Updated: 2023-02-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
61 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-01-31
Study Completion Date
2022-06-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Trial Design:
This clinical trial is a phase III multicenter, randomized, double blind and controlled with placebo trial and with two arms designed to assess the efficiency and toxicity of the scheme Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic syndrome associated to 5q deletion with anemia (Hb≤12g/dL) but without the need of transfusion. Patients are randomized in the study in a 2:1 ratio. They will receive treatment for 104 weeks until progression of the disease, which implies that the patient suffering from anemia due to myelodysplastic syndrome requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months), or unacceptable toxicity.
Disease:
Low risk myelodysplastic syndrome associated to the loss of 5q without transfusion requirements.
Total number of patients:
In total 60 patients will be included, 40 assigned to the treatment branch and 20 to the placebo branch.
Calendar:
First patient first visit: February 2010, and Last patient last visit expected in February 2016. (Recruitment was initially expected to take place over a period of 24 months and was expected to be finished in February 2012, but due to low rate of recruitment it was extended until the population sample is included in the trial).
This clinical trial is a phase III multicenter, randomized, double blind and controlled with placebo trial and with two arms designed to assess the efficiency and toxicity of the scheme Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic syndrome associated to 5q deletion with anemia (Hb≤12g/dL) but without the need of transfusion. Patients are randomized in the study in a 2:1 ratio. They will receive treatment for 104 weeks until progression of the disease, which implies that the patient suffering from anemia due to myelodysplastic syndrome requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months), or unacceptable toxicity.
Disease:
Low risk myelodysplastic syndrome associated to the loss of 5q without transfusion requirements.
Total number of patients:
In total 60 patients will be included, 40 assigned to the treatment branch and 20 to the placebo branch.
Calendar:
First patient first visit: February 2010, and Last patient last visit expected in February 2016. (Recruitment was initially expected to take place over a period of 24 months and was expected to be finished in February 2012, but due to low rate of recruitment it was extended until the population sample is included in the trial).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q
NCT01029262
Anemia
COMPLETED
PHASE3
Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality
NCT00179621
Myelodysplastic Syndromes
COMPLETED
PHASE3
The Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion Dependent Subjects With Myelodysplastic Syndrome (MDS) Associated With Del (5q) Abnormality
NCT00874978
Myelodysplastic Syndromes
COMPLETED
PHASE2
Revlimid in Transfusion Dependent Patients
NCT01178814
Myelodysplastic Syndrome
COMPLETED
PHASE2
Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
NCT00352365
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
+14 more
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
General summary of myelodysplastic syndrome with alteration in 5q. Myelodysplastic syndromes (MDS) are a very heterogenic group of diseases characterized by the presence of morphologic features of dyshemopoiesis in bone marrow (BM) and in peripheral blood (PB), which is translated into an inefficient hematopoiesis. This will lead to the concomitant development of peripheral cytopenias which will be the cause of complications in these patients and, in most cases, the cause of death. In addition, these patients have an increased risk of developing acute leukemia, and this risk increases with the progression of the disease.MDS represents an incurable disease with standard treatments with a quite variable survival mean ranging from 3 months to 15 years depending on the number of blasts, the number of cytopenias and the type of cytogenetic disorders2. The sole curative treatment of the MDS is the allogenic transplant of hematopoietic progenitors but this option is only available for a 5% of the patients with MDS.
Lenalidomide, initially known as CC-5013, is an analogue of the immunomodulator Drug Thalidomide (Thalidomid®; Pharmion Corp., Boulder, CO, USA), which was the first drug with anti-angiogenic and immunomodulator properties investigated in MDS. Lenalidomide has, as well as thalidomide, a broad array of potential activities against dysplastic cells, not fully known, among which we find immunomodulator and non-immunomodulator properties (anti-angiogenic effect, anti-proliferative and pro-apoptotic). The greater advantage of Lenalidomide in comparison with thalidomide is that the former is between 50 and 2000 times stronger tan thalidomide in what respects to its immunomodulator effects. And moreover, the toxic profile of Lenalidomide seems lower than that of its analogue; Thalidomide.
There is no treatment indication on the present times for patients with low risk MDS associated to the loss of 5q without transfusion dependent anemia. The results with Lenalidomide are highly promising for patients with low risk MDS associated to the loss of 5q when (it has so been tested) there is red blood cells transfusion dependent anemia. In this sense, the proposal consists on being able to state that treatment with Lenalidomide can be efficient from diagnose preventing CH transfusions with an acceptable toxicity.
In this sense, the present study has the intention to treat early patients with low-risk MDS associated to the loss of 5q with a view to prevent CH transfusion. Therefore, we could extend in these patients the time until CH transfusion and even assess the possibility of eradicating the disease at a cytogenetic/morphologic level. In the present trial and given the characteristics of the patients, we have chosen the option of supplying Lenalidomide at a dose of 5mg/day. The option of considering a lower dose to the one currently considered as "standard" (10mg/day) is to reduce toxicity, mainly hematologic, in patients who do not receive treatment normally. A dose with lower toxicity has been chosen which has revealed itself efficient.
Main efficiency objective:
•To assess if treatment with Revlimid (Lenalidomide) extends the period until the progression to myelodysplastic syndrome del(5q) considered as transfusion independent, documented verification that the patient suffering from anemia due to MDS requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months). Revlimid will be compared to the current standard treatment for patients with low risk myelodysplastic syndrome associated with the loss of 5qwithout transfusion dependent anemia, which is the therapeutic abstention and monitoring until its progression.
Secondary efficiency objectives:
* Erythroid response according to the Criteria of the myelodysplastic syndrome International Work Team 2006).
* Duration of the red blood cells transfusion independency (defined as the number of days elapsed between the randomization and the first transfusion after this period free of transfusions).
* Change of hemoglobin concentration (Hb) in relation to baseline levels of patients who show erythroid response.
* Variation in platelets absolute count in relation to baseline levels.
* Variation in neutrophils absolute count in relation to baseline levels.
* Cytogenetic response according to the Criteria of the myelodysplastic syndrome International Work Team.
* Bone marrow response according to the Criteria of the myelodysplastic syndrome International Work Team.
* To assess the safety and tolerance of the Lenalidomide scheme, measured according to the incidence of clinical and laboratory toxicity.
* Global survival, Event Free Survival and Rate of Transformation to Acute Leukemia.
* Time from diagnose to transfusion independence.
Main safety objective:
Safety (type, frequency and severity \[Criteria of normal terminology of adverse reactions of the National Cancer Institute (NCI CTCAE) version 3.0\] of adverse reactions (AR)and list of the AR with Lenalidomide.
Four of the sites of this Clinical Trial are member of the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet) which is partially co-funded by the European Union within the framework of the Third Health Programme. "ERN-2016 - Framework Partnership Agreement 2017-2021." FPA 739541".
Lenalidomide, initially known as CC-5013, is an analogue of the immunomodulator Drug Thalidomide (Thalidomid®; Pharmion Corp., Boulder, CO, USA), which was the first drug with anti-angiogenic and immunomodulator properties investigated in MDS. Lenalidomide has, as well as thalidomide, a broad array of potential activities against dysplastic cells, not fully known, among which we find immunomodulator and non-immunomodulator properties (anti-angiogenic effect, anti-proliferative and pro-apoptotic). The greater advantage of Lenalidomide in comparison with thalidomide is that the former is between 50 and 2000 times stronger tan thalidomide in what respects to its immunomodulator effects. And moreover, the toxic profile of Lenalidomide seems lower than that of its analogue; Thalidomide.
There is no treatment indication on the present times for patients with low risk MDS associated to the loss of 5q without transfusion dependent anemia. The results with Lenalidomide are highly promising for patients with low risk MDS associated to the loss of 5q when (it has so been tested) there is red blood cells transfusion dependent anemia. In this sense, the proposal consists on being able to state that treatment with Lenalidomide can be efficient from diagnose preventing CH transfusions with an acceptable toxicity.
In this sense, the present study has the intention to treat early patients with low-risk MDS associated to the loss of 5q with a view to prevent CH transfusion. Therefore, we could extend in these patients the time until CH transfusion and even assess the possibility of eradicating the disease at a cytogenetic/morphologic level. In the present trial and given the characteristics of the patients, we have chosen the option of supplying Lenalidomide at a dose of 5mg/day. The option of considering a lower dose to the one currently considered as "standard" (10mg/day) is to reduce toxicity, mainly hematologic, in patients who do not receive treatment normally. A dose with lower toxicity has been chosen which has revealed itself efficient.
Main efficiency objective:
•To assess if treatment with Revlimid (Lenalidomide) extends the period until the progression to myelodysplastic syndrome del(5q) considered as transfusion independent, documented verification that the patient suffering from anemia due to MDS requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months). Revlimid will be compared to the current standard treatment for patients with low risk myelodysplastic syndrome associated with the loss of 5qwithout transfusion dependent anemia, which is the therapeutic abstention and monitoring until its progression.
Secondary efficiency objectives:
* Erythroid response according to the Criteria of the myelodysplastic syndrome International Work Team 2006).
* Duration of the red blood cells transfusion independency (defined as the number of days elapsed between the randomization and the first transfusion after this period free of transfusions).
* Change of hemoglobin concentration (Hb) in relation to baseline levels of patients who show erythroid response.
* Variation in platelets absolute count in relation to baseline levels.
* Variation in neutrophils absolute count in relation to baseline levels.
* Cytogenetic response according to the Criteria of the myelodysplastic syndrome International Work Team.
* Bone marrow response according to the Criteria of the myelodysplastic syndrome International Work Team.
* To assess the safety and tolerance of the Lenalidomide scheme, measured according to the incidence of clinical and laboratory toxicity.
* Global survival, Event Free Survival and Rate of Transformation to Acute Leukemia.
* Time from diagnose to transfusion independence.
Main safety objective:
Safety (type, frequency and severity \[Criteria of normal terminology of adverse reactions of the National Cancer Institute (NCI CTCAE) version 3.0\] of adverse reactions (AR)and list of the AR with Lenalidomide.
Four of the sites of this Clinical Trial are member of the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet) which is partially co-funded by the European Union within the framework of the Third Health Programme. "ERN-2016 - Framework Partnership Agreement 2017-2021." FPA 739541".
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Myelodysplastic Syndrome
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
lenalidomide
Experimental treatment branch with Lenalidomide 5 mg/day (oral use)
Group Type
EXPERIMENTAL
Lenalidomide
Intervention Type
DRUG
Treatment with Revlimid (lenalidomide), oral use, 5 mg daily during study treatment (104 weeks).
placebo
Placebo branch (oral use)
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
Placebo, oral use, daily during study treatment (104 weeks)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lenalidomide
Treatment with Revlimid (lenalidomide), oral use, 5 mg daily during study treatment (104 weeks).
Intervention Type
DRUG
Placebo
Placebo, oral use, daily during study treatment (104 weeks)
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Revlimid 5 mg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. \- The patient must, in the investigator's opinion, be able to comply with all the clinical trial requirements.
2. \- The patient must voluntarily sign the informed consent form before undergoing any test of the trial that is not part of the normal patient care, and patient must be aware that he/she can withdraw from the trial at any time, without it ever affecting their future healthcare.
3. \- Age \> 18 years.
4. \- The patient must be diagnosed with low risk MDS (low and intermediate-1 IPSS) associated with 5q deletion, either as an isolated abnormality or accompanied by other additional cytogenetic abnormalities.
5. \- MDS Del(5q) with transfusion-independent anaemia (Hb ≤ 12 g/dL), and documented confirmation that no packed red blood cells transfusion due to the patient's underlying condition (MDS) has been received.
6. \- The patient must have an ECOG performance status of ≤ 2.
7. \- The patient must be able to comply with the scheduled study visits.
8. \- Female patient with childbearing potential must\*:
* Understands the teratogenic risk of the study drug.
* Commits herself to use two forms of effective birth control continuously, and is able to use them correctly, for the 4 weeks prior to starting treatment with the study drug, as well as during treatment with the study drug (including periods of dose interruption), and for up to 4 weeks after finishing treatment with the study drug, even if amenorrhoeic. This always applies, except in women who commit to continued complete sexual abstinence, as confirmed on a monthly basis.
* The patient must understand that even if she is amenorrhoeic she must follow all the advice on effective contraception.
* The patient must understand the possible consequences of pregnancy and the need to attend a healthcare service urgently in case there is a risk of pregnancy.
* Agree to undergo a pregnancy test with a minimum sensitivity of 25 mIU/mL, under medical supervision, on the day of the study visit or during the 3 days prior to this visit, after using effective birth control for at least 4 weeks. This requirement also applies to women with childbearing potential who practice complete and continued sexual abstinence. The test must confirm that the patient is not pregnant at the time the treatment is initiated.
* Agree to undergo a pregnancy test, under medical supervision, weekly for he first 28 days of treatment, and subsequently every 4 weeks, including a pregnancy test 4 weeks after finishing the study treatment, except in case of confirmed tubal ligation. This pregnancy test will be performed on the day of the study visit or during the 3 days prior to it. This requirement also applies to women with childbearing potential who practice complete and continued sexual abstinence.
9. \- All male patients must:
* Commit himself to the use of condoms throughout all the treatment with the study drug, including all periods of dose interruption, and up to one week after finishing the treatment if their partner is a woman with childbearing potential and does not use birth control methods.
* Commit himself to not donate semen during treatment with the study drug and up to one week after finishing the treatment.
10. \- All patients must:
* Refrain from donating blood while receiving treatment with the study drug and during the week following the end of the treatment.
* Refrain from sharing the study drug with others, and return all unused study drug to the investigator or pharmacist.
2. \- The patient must voluntarily sign the informed consent form before undergoing any test of the trial that is not part of the normal patient care, and patient must be aware that he/she can withdraw from the trial at any time, without it ever affecting their future healthcare.
3. \- Age \> 18 years.
4. \- The patient must be diagnosed with low risk MDS (low and intermediate-1 IPSS) associated with 5q deletion, either as an isolated abnormality or accompanied by other additional cytogenetic abnormalities.
5. \- MDS Del(5q) with transfusion-independent anaemia (Hb ≤ 12 g/dL), and documented confirmation that no packed red blood cells transfusion due to the patient's underlying condition (MDS) has been received.
6. \- The patient must have an ECOG performance status of ≤ 2.
7. \- The patient must be able to comply with the scheduled study visits.
8. \- Female patient with childbearing potential must\*:
* Understands the teratogenic risk of the study drug.
* Commits herself to use two forms of effective birth control continuously, and is able to use them correctly, for the 4 weeks prior to starting treatment with the study drug, as well as during treatment with the study drug (including periods of dose interruption), and for up to 4 weeks after finishing treatment with the study drug, even if amenorrhoeic. This always applies, except in women who commit to continued complete sexual abstinence, as confirmed on a monthly basis.
* The patient must understand that even if she is amenorrhoeic she must follow all the advice on effective contraception.
* The patient must understand the possible consequences of pregnancy and the need to attend a healthcare service urgently in case there is a risk of pregnancy.
* Agree to undergo a pregnancy test with a minimum sensitivity of 25 mIU/mL, under medical supervision, on the day of the study visit or during the 3 days prior to this visit, after using effective birth control for at least 4 weeks. This requirement also applies to women with childbearing potential who practice complete and continued sexual abstinence. The test must confirm that the patient is not pregnant at the time the treatment is initiated.
* Agree to undergo a pregnancy test, under medical supervision, weekly for he first 28 days of treatment, and subsequently every 4 weeks, including a pregnancy test 4 weeks after finishing the study treatment, except in case of confirmed tubal ligation. This pregnancy test will be performed on the day of the study visit or during the 3 days prior to it. This requirement also applies to women with childbearing potential who practice complete and continued sexual abstinence.
9. \- All male patients must:
* Commit himself to the use of condoms throughout all the treatment with the study drug, including all periods of dose interruption, and up to one week after finishing the treatment if their partner is a woman with childbearing potential and does not use birth control methods.
* Commit himself to not donate semen during treatment with the study drug and up to one week after finishing the treatment.
10. \- All patients must:
* Refrain from donating blood while receiving treatment with the study drug and during the week following the end of the treatment.
* Refrain from sharing the study drug with others, and return all unused study drug to the investigator or pharmacist.
Exclusion Criteria
1. \- Any organic disease or psychiatric disorder which makes it impossible for the patient to sign or understand the informed consent.
2. \- Having received any treatment for MDS.
3. \- Del(5q) MDS with transfusion-dependent anaemia, and documented confirmation that the patient has received any pRBC transfusion due to the underlying condition (MDS).
4. \- Pregnant or breast-feeding women.
5. \- Any of the following laboratory abnormalities:
* Absolute neutrophil count \< 500/mm3
* Platelet count \< 25,000/mm3
* Serum GOT or GPT \> 3 times the upper limit of normal values.
* Total serum bilirubin \> 2 times the upper limit of normal values.
6. \- Previous history of other malignancies other than MDS (except for basal cell or squamous cell skin carcinoma, or carcinoma in situ of the cervix or breast), unless the patient has been free of disease for more than 5 years.
7. \- Known hypersensitivity to or a history of uncontrollable side effects to lenalidomide.
8. \- Major surgery within the 4 weeks prior to the inclusion in the trial.
9. \- The patient has received any investigational agent in the 30 days prior to inclusion.
2. \- Having received any treatment for MDS.
3. \- Del(5q) MDS with transfusion-dependent anaemia, and documented confirmation that the patient has received any pRBC transfusion due to the underlying condition (MDS).
4. \- Pregnant or breast-feeding women.
5. \- Any of the following laboratory abnormalities:
* Absolute neutrophil count \< 500/mm3
* Platelet count \< 25,000/mm3
* Serum GOT or GPT \> 3 times the upper limit of normal values.
* Total serum bilirubin \> 2 times the upper limit of normal values.
6. \- Previous history of other malignancies other than MDS (except for basal cell or squamous cell skin carcinoma, or carcinoma in situ of the cervix or breast), unless the patient has been free of disease for more than 5 years.
7. \- Known hypersensitivity to or a history of uncontrollable side effects to lenalidomide.
8. \- Major surgery within the 4 weeks prior to the inclusion in the trial.
9. \- The patient has received any investigational agent in the 30 days prior to inclusion.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene Corporation
INDUSTRY
Sponsor Role
collaborator
Fundación General de la Universidad de Salamanca
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Consuelo del Cañizo, MD
Role: STUDY_CHAIR
Hospital Clínico Universitario de Salamanca
María Díez Campelo, MD
Role: STUDY_CHAIR
Hospital Clínico Universitario de Salamanca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpitaux Universitaires de Strasbourg
Strasbourg, Bajo Rin, France
Site Status
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France
Site Status
Centre Hospitalier Régional d'Orléans
Orléans, Loiret, France
Site Status
Centre Hospitalier Universitaire d'Angers
Angers, Maine Y Loira, France
Site Status
Centre Hospitalier Universitaire Brabois
Nancy, Meurthe Y Mosel, France
Site Status
Centre Hospitalier d'Avignon
Avignon, Vaucluse, France
Site Status
Hôspital St. Louis
Paris, , France
Site Status
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, , Germany
Site Status
Marien Hospital Duesseldorf
Düsseldorf, , Germany
Site Status
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Site Status
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Site Status
Hospital Universitari Germans Trias i Pujol (ICO Badalona)
Badalona, Barcelona, Spain
Site Status
Hospital de Cabueñes
Gijón, Principality of Asturias, Spain
Site Status
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Site Status
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Site Status
Hospital Clínic i Provincial
Barcelona, , Spain
Site Status
Hospital Universitario Reina Sofía
Córdoba, , Spain
Site Status
Instituto Catalán de Oncología de Gerona
Girona, , Spain
Site Status
Hospital Infanta Leonor
Madrid, , Spain
Site Status
Hospital Clínico San Carlos
Madrid, , Spain
Site Status
Hospital Universitario La Paz
Madrid, , Spain
Site Status
Hospital General Universitario José Maria Morales Meseguer
Murcia, , Spain
Site Status
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Site Status
Hospital Universitario Virgen del Rocío
Seville, , Spain
Site Status
Hospital Universitario La Fe
Valencia, , Spain
Site Status
Countries
Review the countries where the study has at least one active or historical site.
France
Germany
Spain
References
Explore related publications, articles, or registry entries linked to this study.
Steensma DP, Tefferi A. The myelodysplastic syndrome(s): a perspective and review highlighting current controversies. Leuk Res. 2003 Feb;27(2):95-120. doi: 10.1016/s0145-2126(02)00098-x.
Reference Type
BACKGROUND
Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88.
Reference Type
BACKGROUND
List AF. New approaches to the treatment of myelodysplasia. Oncologist. 2002;7 Suppl 1:39-49. doi: 10.1634/theoncologist.7-suppl_1-39.
Reference Type
BACKGROUND
McHugh SM, Deighton J, Stewart AG, Lachmann PJ, Ewan PW. Bee venom immunotherapy induces a shift in cytokine responses from a TH-2 to a TH-1 dominant pattern: comparison of rush and conventional immunotherapy. Clin Exp Allergy. 1995 Sep;25(9):828-38. doi: 10.1111/j.1365-2222.1995.tb00025.x.
Reference Type
BACKGROUND
Bellamy WT. Expression of vascular endothelial growth factor and its receptors in multiple myeloma and other hematopoietic malignancies. Semin Oncol. 2001 Dec;28(6):551-9. doi: 10.1016/s0093-7754(01)90023-5.
Reference Type
BACKGROUND
Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. doi: 10.1038/nrc1323. No abstract available.
Reference Type
BACKGROUND
List A, Kurtin S, Roe DJ, Buresh A, Mahadevan D, Fuchs D, Rimsza L, Heaton R, Knight R, Zeldis JB. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med. 2005 Feb 10;352(6):549-57. doi: 10.1056/NEJMoa041668.
Reference Type
BACKGROUND
List A, Dewald G, Bennett J, Giagounidis A, Raza A, Feldman E, Powell B, Greenberg P, Thomas D, Stone R, Reeder C, Wride K, Patin J, Schmidt M, Zeldis J, Knight R; Myelodysplastic Syndrome-003 Study Investigators. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med. 2006 Oct 5;355(14):1456-65. doi: 10.1056/NEJMoa061292.
Reference Type
BACKGROUND
List A, Gordon W, Dewald G, Bennett J, Giagounidis A, Raza A et al. Long-term clinical benefit of lenalidomide (Revlimid) treatment in patients with myelodysplastic syndrome and chromosome deletion 5q [Abstract]. Blood. 2006;108:251A.
Reference Type
BACKGROUND
Mallo M, Cervera J et al. Prognostic impact of additional chromosomal aberrations to 5q- in patients with primary myelodysplastic syndromes. Oral comunication, 0906, 13th Congress of the European Hematology Association. Haematologica | 2008; 93(s1), pag. 360
Reference Type
BACKGROUND
Fenaux P, Kelaidi C. Treatment of the 5q- syndrome. Hematology Am Soc Hematol Educ Program. 2006:192-8. doi: 10.1182/asheducation-2006.1.192.
Reference Type
BACKGROUND
Kelaidi C, Eclache V, Fenaux P. The role of lenalidomide in the management of myelodysplasia with del 5q. Br J Haematol. 2008 Feb;140(3):267-78. doi: 10.1111/j.1365-2141.2007.06910.x.
Reference Type
BACKGROUND
List, AF. Active treatment-improving outcomes in del 5q patients. Leukemia Research, (2007)31(Suppl. 1), S9.
Reference Type
BACKGROUND
Diez-Campelo M, Lopez-Cadenas F, Xicoy B, Lumbreras E, Gonzalez T, Del Rey Gonzalez M, Sanchez-Garcia J, Coll Jorda R, Slama B, Hernandez-Rivas JA, Thepot S, Bernal T, Guerci-Bresler A, Bargay J, Amigo ML, Preudhomme C, Fenwarth L, Platzbecker U, Gotze KS, Arar A, Toribio S, Del Canizo C, Hernandez-Rivas JM, Fenaux P. Low dose lenalidomide versus placebo in non-transfusion dependent patients with low risk, del(5q) myelodysplastic syndromes (SintraREV): a randomised, double-blind, phase 3 trial. Lancet Haematol. 2024 Sep;11(9):e659-e670. doi: 10.1016/S2352-3026(24)00142-X. Epub 2024 Jul 18.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-013619-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SINTRA-REV
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT00963105
COMPLETED
PHASE2
Revlimid in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome
NCT00360672
COMPLETED
PHASE2
Lenalidomide for Myelodysplastic Syndrome Refractory to Hypomethylating Agents
NCT01246076
COMPLETED
PHASE2
Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)
NCT02279654
COMPLETED
Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]
NCT00424229
UNKNOWN
PHASE2
A Dose Range Finding Study of Lenalidomide in Non-5q Chromosome Deletion in Low and Intermediate Risk Myelodysplastic Syndrome (MDS) Patients
NCT00699842
TERMINATED
PHASE1/PHASE2
Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
NCT01368757
UNKNOWN
PHASE1/PHASE2
RESPeCT: Revlimid Early Stage Poor Prognosis Chronic Lymphocytic Leukaemia (CLL) Trial
NCT01127542
TERMINATED
PHASE2
Lenalidomide and Recombinant Human Stem Cell Factor for Treatment of Myelodysplasia
NCT00434239
UNKNOWN
EARLY_PHASE1
MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry
NCT01347944
COMPLETED
A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma
NCT01724177
COMPLETED
PHASE2
Lenalidomide in Older Patients With Acute Myeloid Leukemia Without Chromosome 5q Abnormalities
NCT00546897
COMPLETED
PHASE2
A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy
NCT00774345
COMPLETED
PHASE3
Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.
NCT01718379
COMPLETED
PHASE2
A Study of Lenalidomide Maintenance for High-risk Patients With CLL Following First-line Therapy
NCT01556776
COMPLETED
PHASE3
Safety of Lenalidomide and Markers for Disease Progression in Patients With International Prognostic Scoring System (IPSS) Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) With Isolated del5q
NCT01081431
COMPLETED
PHASE2
A Safety and Efficacy Trial of a Combination of Bendamustine, Rituximab and Lenalidomide in Patients With Chronic Lymphocytic Leukemia
NCT01558167
COMPLETED
PHASE1/PHASE2
A Study to Evaluate the Relationship of Lenalidomide With Tumor Flare Reaction and High Tumor Burden in Participants With Relapsed or Refractory Mantle Cell Lymphoma
NCT03647124
COMPLETED
Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
NCT01433965
COMPLETED
PHASE1
Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age
NCT01011894
COMPLETED
PHASE2
A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes
NCT00910858
COMPLETED
PHASE1/PHASE2
Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5
NCT00761449
COMPLETED
PHASE2
A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia
NCT02538965
COMPLETED
PHASE2