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

AML Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01198054
• Other study ID #: LENA-LMA-5
• Status: Terminated
• Phase: Phase 4
• First received: July 29, 2010
• Last updated: April 4, 2014
• Start date: January 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2014
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety and tolerability: Type and intensity of adverse events related with lenalidomide	Type and intensity of adverse events related with lenalidomide	1 year	Yes

External Links

•   Pethema Foundation