Acute Myeloblastic LeukaemiaPhase 4NCT00464217
Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
A Phase 4 study testing ARA-C, Idarubicin and Leucomax in people with Acute Myeloblastic Leukaemia, run by PETHEMA Foundation at 24 sites in Spain.
Trial summary
To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar protocol, decreasing the dose of Idarubicin to try to reduce the deaths in induction Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myeloblastic Leukaemia
- What is being tested?
- ARA-C, Idarubicin and Leucomax
- How many people
- 100 participants
- Where
- 24 sitesSpain
- Study dates
- Oct 1998to Dec 2008
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Cytologic diagnosis of acute myeloblastic leukaemia (excluded M3)
- Over 65 years
Who cannot join
- Previous diagnosis of other malignancy hematopoietic disorder or myelodysplastic syndrome
- Previous treatment with antileucemic chemotherapy
- Psychiatric disorder
- Diagnosis of subtype FAB M3
- Creatinine > 2.5 mg/dL
- Bilirubin , Alkaline Phosphatase or transaminases three times upper the limit
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Spain24 sites
Hospital General de Albacete
Albacete
Hospital Universitario
Alicante
Hospital Puerta del Mar
Cadiz
Hospital Ntra. Sra. del Rossell
Cartagena
Hospital General
Castellon
Hospital de Galdacano
Galdakao
Hospital Ciudad de Jaén
Jaén
Hospital Insular de las Palmas
Las Palmas de Gran Canaria
Hospital Xeral
Lugo
Hospital Clínico San Carlos
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Universitario de Alcalá de Henares
Madrid
Hospital Virgen de la Victoria
Málaga
Hospital Morales Messeguer
Murcia
Hospital Virgen de la Arrixaca
Murcia
Hospital Central de Asturias
Oviedo
Clínica Universitaria de Pamplona
Pamplona
Hospital Montecelo
Pontevedra
Hospital Clínico Universitario
Salamanca
Hospital Arnau de Vilanova
Valencia
Hospital Clínico
Valencia
Hospital Dr. Pesset
Valencia
Hospital Clínico
Valladolid
Hospital Virgen de la Concha
Zamora
About this study
Official title: PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar protocol, decreasing the dose of Idarubicin to try to reduce the deaths in induction
Read the detailed description
INDUCTION TREATMENT :Ara-C 100 mg/m 2 /day in continuous perfusion,days 1 - 7. Idarubicin 8 mg/m 2 /day, days 1 - 3 in bolus. GM-CSF (Leucomax) 5 mcg/kg subcutaneous or endovenous from day + 4 after finishing the chemotherapy until the recovery of neutropenia (> 1.000/mm 3)
CONSOLIDATION TREATMENT The patients who reach a complete response with the first cycle, will receive a second cycle to consolidation. The patients who do not reach a complete response with the first cycle will receive a second cycle. If after two cycles,do not obtain the response, patient should leave the protocol.
INTENSIFICATION TREATMENT All the patients who are in complete response after one cycle of induction and one cycle of consolidation, or after two cycles of induction, will receive a treatment of intensification with: ARA-C 500 mg/m 2 /12 h in one hour infusion, days 1-4. Daunomycin 45 mg/m 2 /day bolu, days 5-7. GM-CSF (Leucomax): 5 mcg/kg from day to + 4 after finishing the chemotherapy until the recovery of neutropenia (>1.000/mm 3)
- Conditions
- Acute Myeloblastic Leukaemia
- Being tested
- ARA-C, Idarubicin, Leucomax
- Keywords
- Acute Myeloblastic Leukaemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARA-CDrug
IdarubicinDrug
LeucomaxDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years
Secondary outcomes (2)
Evaluate the toxicity
Evaluate the effect of haematopoietic growth factors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startOct 1998
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloblastic LeukaemiaStudies 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Garcia Laraña Jose, Dr, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464217
- Sponsor's protocol ID
- PETHEMA/LAM-99
- Status last verified
- Jan 2010
- First submitted
- 20 Apr 2007
- Last updated
- 5 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martinez-Lopez J, Fernandez-Redondo E, Garcia-Sanz R, Montalban MA, Martinez-Sanchez P, Pavia B, Mateos MV, Rosinol L, Martin M, Ayala R, Martinez R, Blanchard MJ, Alegre A, Besalduch J, Bargay J, Hernandez MT, Sarasquete ME, Sanchez-Godoy P, Fernandez M, Blade J, San Miguel JF, Lahuerta JJ; GEM (Grupo Espanol Multidisciplinar de Melanoma)/PETHEMA (Programa para el Estudio de la Terapeutica en Hemopatias Malignas) cooperative study group. Clinical applicability and prognostic significance of molecular response assessed by fluorescent-PCR of immunoglobulin genes in multiple myeloma. Results from a GEM/PETHEMA study. Br J Haematol. 2013 Dec;163(5):581-9. doi: 10.1111/bjh.12576. Epub 2013 Oct 3.
PubMed 24117042
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PETHEMA-LAM99:Treatment of the Acute Myeloblastic Leukaemia in Patients Over 65 Years
- ClinicalTrials.gov ID
- NCT00464217
- Acronym / sponsor ID
- PETHEMA/LAM-99
- Conditions
- Acute Myeloblastic Leukaemia
- Keywords
- Acute Myeloblastic Leukaemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Oct 1998
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Apr 2007 (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.
To reproduce or to improve the index of complete responses of protocol LMA-91 with a similar protocol, decreasing the dose of Idarubicin to try to reduce the deaths in induction
Detailed description
INDUCTION TREATMENT :Ara-C 100 mg/m 2 /day in continuous perfusion,days 1 - 7. Idarubicin 8 mg/m 2 /day, days 1 - 3 in bolus. GM-CSF (Leucomax) 5 mcg/kg subcutaneous or endovenous from day + 4 after finishing the chemotherapy until the recovery of neutropenia (> 1.000/mm 3)
CONSOLIDATION TREATMENT The patients who reach a complete response with the first cycle, will receive a second cycle to consolidation. The patients who do not reach a complete response with the first cycle will receive a second cycle. If after two cycles,do not obtain the response, patient should leave the protocol.
INTENSIFICATION TREATMENT All the patients who are in complete response after one cycle of induction and one cycle of consolidation, or after two cycles of induction, will receive a treatment of intensification with: ARA-C 500 mg/m 2 /12 h in one hour infusion, days 1-4. Daunomycin 45 mg/m 2 /day bolu, days 5-7. GM-CSF (Leucomax): 5 mcg/kg from day to + 4 after finishing the chemotherapy until the recovery of neutropenia (>1.000/mm 3)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Cytologic diagnosis of acute myeloblastic leukaemia (excluded M3)
- Over 65 years
Key exclusion criteria (6 listed)
- Previous diagnosis of other malignancy hematopoietic disorder or myelodysplastic syndrome
- Previous treatment with antileucemic chemotherapy
- Psychiatric disorder
- Diagnosis of subtype FAB M3
- Creatinine > 2.5 mg/dL
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 |
|---|---|---|
| ARA-C | Drug | – |
| Idarubicin | Drug | – |
| Leucomax | Drug | – |
Primary outcome
Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years
2 secondary outcomes
Evaluate the toxicity
Evaluate the effect of haematopoietic growth factors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2010.
- Derived from this study: PubMed 24117042Martinez-Lopez J, Fernandez-Redondo E, Garcia-Sanz R, Montalban MA, Martinez-Sanchez P, Pavia B, Mateos MV, Rosinol L, Martin M, Ayala R, Martinez R, Blanchard MJ, Alegre A, Besalduch J, Bargay J, Hernandez MT, Sarasquete ME, Sanchez-Godoy P, Fernandez M, Blade J, San Miguel JF, Lahuerta JJ; GEM (Grupo Espanol Multidisciplinar de Melanoma)/PETHEMA (Programa para el Estudio de la Terapeutica en Hemopatias Malignas) cooperative study group. Clinical applicability and prognostic significance of molecular response assessed by fluorescent-PCR of immunoglobulin genes in multiple myeloma. Results from a GEM/PETHEMA study. Br J Haematol. 2013 Dec;163(5):581-9. doi: 10.1111/bjh.12576. Epub 2013 Oct 3.
- Spanish association of HaematologyLink provided by the sponsor.
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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.
Garcia Laraña Jose, Dr principal investigator
Hospital Universitario Ramon y Cajal
24 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 ARA-C, Idarubicin and Leucomax in people with Acute Myeloblastic Leukaemia, run by PETHEMA Foundation at 24 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improve the complete response index in patients diagnosed of acute myeloblastic leukaemia over 65 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00464217, which also lists 1 linked publication.
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 5 Jan 2010.