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The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission.
At the same time, the study evaluate the security of lenalidomide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomine | Experimental | Post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Initial dose of oral lenalidomide is 10 mg/day for 28 days every 28 days, during 6 months. In case of response on day 169, patient will follow a treatment extension phase. The dose of lenalidomide should be the same as the last dose for initial phase, until 24 months or progression disease |
| Measure | Description | Time Frame |
|---|---|---|
| Effectivity: Duration of response with lenalidomide after conventional induction chemotherapy | Evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained reponse treatment (total resistance) or partial remission. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Type and intensity of adverse events related with lenalidomide | Type and intensity of adverse events related with lenalidomide | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
AML secondary to treatment with cytostatic or immunosuppressive agents, myelodysplastic syndrome or other neoplastic disease.
AML with cytogenetic abnormalities t (15, 17), t (8; 21), t (16; 16) or inv (16) or their associated molecular rearrangements.
Patients who have received remission induction with a different regime to cytarabine anthracycline / - etoposide.
≤ 60 patients eligible for allogeneic hematopoietic progenitors.
Patients> 60 years eligible for allogeneic hematopoietic stem cell transplant and who have HLA-identical brother.
Patients who have not been evaluated the response to induction chemotherapy (complete remission, partial remission or resistance (see Table 6).
ECOG 3-4.
Any of the following laboratory abnormalities Serum creatinine> 2.0 mg / dl (177 mmol / l). serum aspartate aminotransferase (AST) / glutamic oxalacetic transaminase serum (SGOT) or alanine aminotransferase (ALT) / serum glutamate pyruvate transaminase (SGPT)> 5.0 x upper limit of normal (ULN).
total serum bilirubin> 3 mg / dl.
Patient with known positive HIV serology. No HIV test is required in the process of selection.
Any severe psychiatric condition or disease that prevents the patient sign the informed consent form for the patient or involves an unacceptable risk should participate in the study.
Any serious organic disease or condition that behave for the patient if an unacceptable risk to participate in the study.
Previous use of cytotoxic chemotherapy agents or experimental agents (agents are not commercially available) for the treatment of AML.
Pregnant or breastfeeding (see Section 6.5 on pregnancy prevention plan).
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| Name | Affiliation | Role |
|---|---|---|
| Sanz Miguel, Dr | PETHEMA Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico y Provincial de Barcelona | Barcelona | Barcelona | Spain | |||
| Hospital Clínico San Carlos de Madrid |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
| Madrid |
| Madrid |
| Spain |
| Hospital Juan Canalejo. | A Coruña | Spain |
| Hospital General de Alicante. | Alicante | Spain |
| Hospital Germans Trias I Pujol | Badalona | Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Hospital Ramón y Cajal. Madrid | Madrid | Spain |
| H. Carlos Haya | Málaga | Spain |
| Hospital Central de Asturias. | Oviedo | Spain |
| Hospital Clínico Universitario de Salamanca. | Salamanca | Spain |
| Hospital Universitario Virgen del Rocío. | Seville | Spain |
| Hospital La Fe de Valencia | Valencia | Spain |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |