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

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ClinicalTrials.gov Identifier: NCT01198054
Recruitment Status : Terminated
First Posted : September 9, 2010
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Tracking Information
First Submitted Date  ICMJE July 29, 2010
First Posted Date  ICMJE September 9, 2010
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01198054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE AML
Intervention  ICMJE 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

Study Arms  ICMJE Experimental: Lenalidomine
Post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5)
Intervention: Drug: Lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 4, 2014)
4
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2010)
30
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01198054
Other Study ID Numbers  ICMJE LENA-LMA-5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PETHEMA Foundation
Study Sponsor  ICMJE PETHEMA Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanz Miguel, Dr PETHEMA Foundation
PRS Account PETHEMA Foundation
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP