AMLPhase 4NCT01198054
LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)
A Phase 4 study testing Lenalidomide in people with AML, run by PETHEMA Foundation at 12 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 12 sitesSpain
- Study dates
- Jan 2011to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Juan Canalejo.
A Coruña
Hospital General de Alicante.
Alicante
Hospital Germans Trias I Pujol
Badalona
Hospital Clínico y Provincial de Barcelona
Barcelona, Barcelona
Hospital Clínico San Carlos de Madrid
Madrid, Madrid
Hospital 12 de Octubre
Madrid
Hospital Ramón y Cajal. Madrid
Madrid
H. Carlos Haya
Málaga
Hospital Central de Asturias.
Oviedo
Hospital Clínico Universitario de Salamanca.
Salamanca
Hospital Universitario Virgen del Rocío.
Seville
Hospital La Fe de Valencia
Valencia
About this study
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
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.
- Conditions
- AML
- Being tested
- Lenalidomide
- Keywords
- AML, Lenalidomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
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 group | Role | What they receive |
|---|---|---|
| Lenalidomine | Experimental | Post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5) Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Safety and tolerability: Type and intensity of adverse events related with lenalidomide
Type and intensity of adverse events related with lenalidomide
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanz Miguel, Dr, Principal investigator, PETHEMA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198054
- Sponsor's protocol ID
- LENA-LMA-5
- Status last verified
- Apr 2014
- First submitted
- 29 Jul 2010
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01198054
- Acronym / sponsor ID
- LENA-LMA-5
- Conditions
- AML
- Keywords
- AML, Lenalidomide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomine | Experimental | Drug: LenalidomidePost-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideInitial 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 | Drug | Lenalidomine |
Primary outcome
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.
1 secondary outcome
Safety and tolerability: Type and intensity of adverse events related with lenalidomide
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanz Miguel, Dr principal investigator
PETHEMA Foundation
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lenalidomide in people with AML, run by PETHEMA Foundation at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectivity: Duration of response with lenalidomide after conventional induction chemotherapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.