Hemotrial Un proyecto de SEHH

Ensayo clínico

A multicenter, randomized, double-blind, placebo-controlled, 3-arm study of the efficacy and safety of 2 doses of lenalidomide versus placebo in red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk myelodyplastic syndromes (MDS) associated with a deletion (del) 5q[31] cytogenetic abnormality.

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A multicenter, randomized, double-blind, placebo-controlled, 3-arm study of the efficacy and safety of 2 doses of lenalidomide versus placebo in red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk myelodyplastic syndromes (MDS) associated with a deletion (del) 5q[31] cytogenetic abnormality.


Resumen

2017-03-15 03:56:42
2005-000454-73
CC-5013-MDS-004
A multicenter, randomized, double-blind, placebo-controlled, 3-arm study of the efficacy and safety of 2 doses of lenalidomide versus placebo in red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk myelodyplastic syndromes (MDS) associated with a deletion (del) 5q[31] cytogenetic abnormality.
CC-5013-MDS-004

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Celgene Europe Limited United Kingdom

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
Lenalidomide
CC-5013 Capsule*
Oral use

Detalles del Fármaco (Principio Activo):

CC-5013 3-(4’aminoisoin

Concentración del fármaco:

mg milligram(s) equal

5

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

Si
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Capsule*

Oral use

Información General



Síndrome Mielodisplásico

Transfusion-dependent, low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality.


To compare the efficacy of 2 doses of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk (International Prognostic Scoring System [IPSS]) MDS associated with a deletion (del) 5q[31] cytogenetic abnormality.

To compare the safety of 2 doses of lenalidomide to that of placebo in subjects with RBC transfusion-dependent low- or intermediate-1-risk MDS associated with a del 5q[31] cytogenetic abnormality.

Information no disponible en EudraCT


Study population: Pre-Randomization Phase 1. Must understand and voluntarily sign an informed consent form2. Must be ? 18 years of age at the time of signing the informed consent form3. Must be able to adhere to the study visit schedule and other protocol requirements4. Concurrent corticosteroids used for medical conditions other than MDS is allowed provided subject is on a stable or decreasing dose for ? 1 week prior to study entry5. Prior thalidomide allowed6. Documented diagnosis of MDS that meets IPSS criteria for low- to intermediate-1-risk disease and has an associated del 5q[31] cytogenetic abnormality (the deleted chromosomal region must include 5q[31])7. RBC transfusion-dependent anemia defined as not having any consecutive 56 days without a RBC transfusion within at least the immediate 112 days (4 months). Note: A 112 day documented transfusion history is required for subjects to enter the double-blind phase of the study.Study population: Double-Blind Treatment Phase1. Must understand and voluntarily sign an informed consent form2. Age ? 18 years at the time of signing the informed consent form3. Must be able to adhere to the study visit schedule and other protocol requirements4. Documented diagnosis of MDS that meets IPSS criteria for low- to intermediate-1-risk disease and has an associated del 5q[31] cytogenetic abnormality (the deleted chromosomal region must include 5q[31])5. RBC transfusion-dependent anemia defined as not having any consecutive 56 days without a RBC transfusion within at least the immediate 112-days prior to randomization. 6. Adequate slides of baseline bone marrow aspirate, marrow aspirate iron stain, bone marrow biopsy, and peripheral blood smear have been sent to Central Reviewer7. Baseline RBC transfusion requirement has been calculated8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test prior to starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, patches, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.

Study population: Pre-Randomization Phase1. Pregnant or lactating females.2. Prior therapy with lenalidomide3. Proliferative (WBC ? 12,000/mL) chronic myelomonocytic leukemia (CMML)4. Prior ? grade-2 NCI CTCAE (v 3.0) allergic reaction to thalidomide5. Prior desquamating (blistering) rash while taking thalidomide6. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ? 3 years7. Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days8. Less than 6 months since prior allogeneic bone marrow transplantation9. Less than 3 months since prior autologous bone marrow or stem cell transplantation10. Less than 28 days since prior myelosuppressive anticancer biologic therapy11. Recombinant human erythropoietin (rHuEPO) therapy received within 28 days12. Use of androgens other than to treat hypogonadism is prohibited13. Known HIV-1 positivity14. Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the studyStudy population: Double-Blind Treatment Phase1. Pregnant or lactating females2. Prior therapy with lenalidomide3. Proliferative (WBC ? 12,000/mL) CMML4. Any of the following laboratory abnormalities:- Absolute neutrophil count (ANC) < 500 cells/mL (0.5 x 109/L)- Platelet count < 25,000/?L (25 x 109/L)- Serum creatinine > 2.0 mg/dL (177 mmol/L)- Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN)- Serum total bilirubin > 1.5 mg/dL5. Prior ? grade-2 NCI CTCAE allergic reaction to thalidomide6. Prior desquamating (blistering) rash while taking thalidomide7. Subjects with ? grade-2 neuropathy8. Clinically significant anemia owing to iron, B12, or folate deficiencies, or autoimmune or hereditary hemolysis or gastrointestinal bleeding (the subject must have a marrow aspirate that is evaluable for storage iron)9. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ? 3 years10. Use of androgens other than to treat hypogonadism is prohibited 11. Known HIV-1 positivity12. Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study

RBC transfusion-independence for ? 26 weeks (182 days)

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
No

Si

Centros participantes:


Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

1
10
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


20

Para estudios internacionales:


162
162

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado