- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01198054
LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)
PILOT STUDY PHASE II, Multicenter, Non-randomized, TO ASSESS THE EFFICACY AND SAFETY OF LENALIDOMIDE IN INDUCTION AND POST-INDUCTION IN PATIENTS WITH NOVO Acute Myeloid Leukemia (AML) WITH Cytogenetic Abnormality Monosomy 5
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Alicante, Spain
- Hospital General de Alicante.
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Badalona, Spain
- Hospital Germans Trias i Pujol
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Barcelona, Spain
- Hospital Clinico y Provincial de Barcelona
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La Coruña, Spain
- Hospital Juan Canalejo.
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Madrid, Spain
- Hospital Clínico San Carlos de Madrid
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Madrid, Spain
- Hospital 12 de octubre
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Madrid, Spain
- Hospital Ramón y Cajal. Madrid
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Málaga, Spain
- H. Carlos Haya
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Oviedo, Spain
- Hospital Central de Asturias.
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Salamanca, Spain
- Hospital Clínico Universitario de Salamanca.
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Sevilla, Spain
- Hospital Universitario Virgen del Rocío.
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Valencia, Spain
- Hospital La Fe de Valencia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirm the diagnosis of AML according to WHO criteria (Annex 4).
- AML de novo (ie, patients without documented history of previous treatment with antineoplastic agents for radiotherapy or other oncological diseases, hematological or immunological, related to the development of secondary LMAs and secondary AML patients without primary MDS with del (5q) or -5 [documented history of primary MDS with transformation to LMAs]).
- Diagnostic confirmation of the abnormality del (5q) or -5, with or without other cytogenetic abnormalities. It is not necessary that the del (5q) including band 5q31.
- Patients who have received one cycle of induction chemotherapy consisting of a classical combination of anthracycline and cytarabine (with or without etoposide as a third agent associated), regardless of the response.
- Patients have been evaluated the response to induction chemotherapy with anthracyclines and cytarabine (with or without etoposide as third agent partner) and were classified according to the criteria of IWG.20
- ≤ 60 patients ineligible for allogeneic hematopoietic progenitors.
- Patients> 60 years are not eligible for allogeneic hematopoietic stem cell, or eligible but did not have HLA-identical brother.
- Accept the use of any contraceptive method effective in patients of childbearing age with reproductive potential (see Section 6.5 on pregnancy prevention plan).
- Ability to understand and voluntarily sign informed consent form.
- Age ≥ 18 years at the time of signing the informed consent form.
- Ability and willingness to follow the schedule of study visits.
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lenalidomine
Post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5)
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectivity: Duration of response with lenalidomide after conventional induction chemotherapy
Time Frame: 12 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability: Type and intensity of adverse events related with lenalidomide
Time Frame: 1 year
|
Type and intensity of adverse events related with lenalidomide
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sanz Miguel, Dr, PETHEMA Foundation
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LENA-LMA-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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