LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT01198054
First received: July 29, 2010
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
AML
Drug: Lenalidomide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Effectivity: Duration of response with lenalidomide after conventional induction chemotherapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety and tolerability: Type and intensity of adverse events related with lenalidomide [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Type and intensity of adverse events related with lenalidomide


Enrollment: 4
Study Start Date: January 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomine
Post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5)
Drug: Lenalidomide

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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirm the diagnosis of AML according to WHO criteria (Annex 4).
  2. 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]).
  3. 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.
  4. 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.
  5. 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
  6. ≤ 60 patients ineligible for allogeneic hematopoietic progenitors.
  7. Patients> 60 years are not eligible for allogeneic hematopoietic stem cell, or eligible but did not have HLA-identical brother.
  8. Accept the use of any contraceptive method effective in patients of childbearing age with reproductive potential (see Section 6.5 on pregnancy prevention plan).
  9. Ability to understand and voluntarily sign informed consent form.
  10. Age ≥ 18 years at the time of signing the informed consent form.
  11. Ability and willingness to follow the schedule of study visits.

Exclusion Criteria:

  1. AML secondary to treatment with cytostatic or immunosuppressive agents, myelodysplastic syndrome or other neoplastic disease.
  2. AML with cytogenetic abnormalities t (15, 17), t (8; 21), t (16; 16) or inv (16) or their associated molecular rearrangements.
  3. Patients who have received remission induction with a different regime to cytarabine anthracycline / - etoposide.
  4. ≤ 60 patients eligible for allogeneic hematopoietic progenitors.
  5. Patients> 60 years eligible for allogeneic hematopoietic stem cell transplant and who have HLA-identical brother.
  6. Patients who have not been evaluated the response to induction chemotherapy (complete remission, partial remission or resistance (see Table 6).
  7. ECOG 3-4.
  8. 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.

  9. Patient with known positive HIV serology. No HIV test is required in the process of selection.
  10. 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.
  11. Any serious organic disease or condition that behave for the patient if an unacceptable risk to participate in the study.
  12. Previous use of cytotoxic chemotherapy agents or experimental agents (agents are not commercially available) for the treatment of AML.
  13. Pregnant or breastfeeding (see Section 6.5 on pregnancy prevention plan).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198054

Locations
Spain
Hospital General de Alicante.
Alicante, Spain
Hospital Germans Trias I Pujol
Badalona, Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, Spain
Hospital Juan Canalejo.
La Coruña, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos de Madrid
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.
Sevilla, Spain
Hospital La Fe de Valencia
Valencia, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Principal Investigator: Sanz Miguel, Dr PETHEMA Foundation
  More Information

No publications provided

Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT01198054     History of Changes
Other Study ID Numbers: LENA-LMA-5
Study First Received: July 29, 2010
Last Updated: April 4, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
AML
Lenalidomide

Additional relevant MeSH terms:
Chromosome Aberrations
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014