Acute Lymphoblastic LeukemiaPhase 4LAL-AR-N-2005NCT00526409
LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
A Phase 4 study testing Prednisolone, Daunorubicin and Vincristine in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 4 sites in Spain.
Trial summary
The study objective is to improve the global results obtained with LAL-AR-93 study, reaching an event free survival between 60-70%. Identify patients with bad prognosis, with minimal residual disease,who can benefit of allogenic bone marrow transplantation Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Prednisolone, Daunorubicin and Vincristine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 40 participants
- Where
- 4 sitesSpain
- Study dates
- Jun 2005to Oct 2014
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- High risk children with acute lymphoblastic leukemia
Who cannot join
- Mature B-ALL (FABL3)
- Mixed forms of ALL
- Patients with coronary disorders, valvular or hypertensive cardiopathy
- Patients with chronic liver disorders
- Chronic pulmonary disorders
- Renal insufficiency
- Neurologic disfunctions
- ECOG 3 and 4
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital materno Infantil vall d'Hebrón
Barcelona
Hospital Niño Jesús
Madrid
Hospital Infantil Carlos Haya
Málaga
Hospital Virgen de la Arrixaca
Murcia
About this study
Official title: LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
The study objective is to improve the global results obtained with LAL-AR-93 study, reaching an event free survival between 60-70%.
Identify patients with bad prognosis, with minimal residual disease,who can benefit of allogenic bone marrow transplantation
Read the detailed description
INDUCTION TREATMENT
Systemic chemotherapy:
PREDNISOLONE 60 mg/m2 /day, oral or i.v. x 21 days (1 to 22) 30 mg/m2 /day, oral or i.v. x 7 days (23 to 29)
DAUNORUBICIN 30 mg/m2 , i.v. days 1,8,15 and 22
VINCRISTINE 1,5 mg/m2, i.v. days 1,8,15 and 22
L-ASPARAGINASE 10.000U/m2 i.m or i.v day 9,11,13,16,18,20,23,25 and 27
CYCLOPHOSPHAMIDE 500 mg/m2 i.v. days 1,2 and 29
Intrathecal chemotherapy:
Days 1 and 22 according age:
Age <1 years 1-3 years >3 years
Methotrexate (MTX), mg 5 8 12 Ara-C, mg 16 20 30 Hydrocortisone,mg 10 10 20
Patients with <10% blasts in M.O (day 14), and in complete response on week 5 or 6, and without MDR, start consolidation-intensification phase.
Patients with >10% blasts in MO day +14 or without CR after induction treatment, start consolidation-intensification phase and identifier a donor for a transplantation.
CONSOLIDATION/INTENSIFICATION (C.I.)
Two sequential cycles, alternating bloc I and bloc II
BLOC I
DEXAMETHASONE 10 mg/m2/d vo. days 1 to 5 and 5 mg/m2/d vo. days 6 and 7
VINCRISTINE 1.5 mg/m2/d, i.v. days 1 and 8
METHOTREXATE 5 g/m2 24 hours infusion + AF, day 1
ARA-C 1 g/m2/12 h, i.v., days 5 and 6
MERCAPTOPURINE 100 mg/m2/d, oral, days 1 to 5
CYCLOPHOSPHAMIDE 500 mg/m2 i.v. el day +8
INTRATHECAL CHEMOTHERAPY day 1.
BLOC II
DEXAMETHASONE 10 mg/m2/d, v o. days 1-5 and 5 mg/m2/d, v o. days 6 and 7
VINCRISTINE 1.5 mg/m2/d, days 1 and 8
METHOTREXATE 5 g/m2 24 h infusion + AF, day 1
ARA-C 1 g/m2 i.v/12 h, days 5 and 6
DAUNORUBICINE 30 mg/m2 i.v.day 1
L-ASPARAGINASE 20.000 u/m2/d, i.m. or i.v. day 7
INTRATHECAL CHEMOTHERAPY day 1
Patients with CR and MRD negative, follow chemotherapy. Patients with MDR >0.01% after second cycle or considered previously MRD are candidates to allogenic transplantation after second cycle.
REINDUCTION/INTENSIFICATION TREATMENT (R.I.)
PREDNISOLONE 60 mg/m2/d, oral x 14 days (1-14) 30 mg/m2/d, oral x 7 days (15-22)
VINCRISTINE 1.5 mg/m2, i.v. x 2 days 1 and 8
DAUNORUBICINE 30 mg/m2 i.v x 2 , days 1 and 8
CYCLOPHOSPHAMIDE 500 mg/m2 I.V. day 15
-----------------------------------------
METHOTREXATE 3 g/m2 /24 h infusion + AF day 29
MERCAPTOPURINE 50 mg/m2/d, oral, days 29-35 and 43-50
ARA-C 1 g/m2/12 h., i.v., days 43 and 44
INTRATHECAL CHEMOTHERAPY , days 1, 15, 29 and 43
MAINTENANACE TREATMENT (M1)
Six cycles of:
MERCAPTOPURINE 50 mg/m2/d, oral x 21 days (1-21)
METHOTREXATE 20 mg/m2/d, i.m. /week x 3 (1,7,14)
PREDNISOLONE 60 mg/m2/d, oral x 7 days (22-28)
VINCRISTINE 1.5 mg/m2 i.v.day 22
ASPARAGINASE 20.000 u/m2 i.m. day 22
INTRATHECAL CHEMOTHERAPY day 22
MAINTENANCE TREATMENT (M2)
Diary mercaptopurine and weekly methotrexate at previous doses, until complete 24 months.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Prednisolone, Daunorubicin, Vincristine, L-Asparaginase, Cyclophosphamide
- Keywords
- Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Induction: 60 mg/m2/day, oral or i.v x 21 days and 30 mg/m2/day oral or iv x 7 days Reinduction-Intensification Treatment: 60 mg/m2/d x 14 days and 30 mg/m2/day oral x 7 days
DaunorubicinDrug
Induction: 30 mg/m2, i.v, days 1, 8, 15, 22 Consolidation (Bloc II)30 mg/m2, i.v, day 1
VincristineDrug
Induction: 1,5 mg/m2 iv, days 1, 8, 15, 22 Consolidation (Bloc I):1,5 mg/m2 iv, days 1, 8 Consolidation (Bloc II):1,5 mg/m2 iv, days 1, 8 Reinduction: 1,5 mg/m2 iv, days 1, 8 Maintenance:1,5 mg/m2 iv, day 22
L-AsparaginaseDrug
Induction: 10.000 U/m2 im or iv, days 9,11,13,16,18,20,23,25,27 Consolidation (Bloc II): 20.000 U/m2 im or iv, day 7 Maintenance: 20.000 U/m2 im or iv, day 22
CyclophosphamideDrug
Induction: 500 mg/m2 iv, days 1, 2, 29 Consolidation (Bloc I): 500 mg/m2 iv, day 8 Reinduction:500 mg/m2 iv, day 15
MethotrexateDrug
Consolidation (Bloc I): 5 g/m2 24 hours infusion Consolidation (Bloc II): 5 g/m2 24 hours infusion Reinduction: 3 g/m2 24 hours infusion Maintenance: 20 mg/m2/d, IM/week x 3 (1, 7, 14)
Cytosine ArabinosideDrug
Consolidation (Bloc I): 1 g/m2/12 h iv, days 5, 6 Consolidation (Bloc II): 1 g/m2/12 h iv, days 5, 6 Reinduction: 1 g/m2/12 h iv, days 43, 44
What is being measured
The primary outcome is the main question the study is designed to answer.
To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJun 2005
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bastida Pilar, Dr, Study chair, Hospital Universitari Materno-Infantil Vall d'HebronRibera Josep Mª, Dr, Study chair, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526409
- Sponsor's protocol ID
- LAL-AR-N-2005
- Acronym
- LAL-AR-N-2005
- Status last verified
- Oct 2014
- First submitted
- 6 Sep 2007
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00526409
- Acronym / sponsor ID
- LAL-AR-N-2005 / LAL-AR-N-2005
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Sep 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.
The study objective is to improve the global results obtained with LAL-AR-93 study, reaching an event free survival between 60-70%.
Identify patients with bad prognosis, with minimal residual disease,who can benefit of allogenic bone marrow transplantation
Detailed description
INDUCTION TREATMENT
Systemic chemotherapy:
PREDNISOLONE 60 mg/m2 /day, oral or i.v. x 21 days (1 to 22) 30 mg/m2 /day, oral or i.v. x 7 days (23 to 29)
DAUNORUBICIN 30 mg/m2 , i.v. days 1,8,15 and 22
VINCRISTINE 1,5 mg/m2, i.v. days 1,8,15 and 22
L-ASPARAGINASE 10.000U/m2 i.m or i.v day 9,11,13,16,18,20,23,25 and 27
CYCLOPHOSPHAMIDE 500 mg/m2 i.v. days 1,2 and 29
Intrathecal chemotherapy:
Days 1 and 22 according age:
Age <1 years 1-3 years >3 years
Methotrexate (MTX), mg 5 8 12 Ara-C, mg 16 20 30 Hydrocortisone,mg 10 10 20
Patients with <10% blasts in M.O (day 14), and in complete response on week 5 or 6, and without MDR, start consolidation-intensification phase.
Patients with >10% blasts in MO day +14 or without CR after induction treatment, start consolidation-intensification phase and identifier a donor for a transplantation.
CONSOLIDATION/INTENSIFICATION (C.I.)
Two sequential cycles, alternating bloc I and bloc II
BLOC I
DEXAMETHASONE 10 mg/m2/d vo. days 1 to 5 and 5 mg/m2/d vo. days 6 and 7
VINCRISTINE 1.5 mg/m2/d, i.v. days 1 and 8
METHOTREXATE 5 g/m2 24 hours infusion + AF, day 1
ARA-C 1 g/m2/12 h, i.v., days 5 and 6
MERCAPTOPURINE 100 mg/m2/d, oral, days 1 to 5
CYCLOPHOSPHAMIDE 500 mg/m2 i.v. el day +8
INTRATHECAL CHEMOTHERAPY day 1.
BLOC II
DEXAMETHASONE 10 mg/m2/d, v o. days 1-5 and 5 mg/m2/d, v o. days 6 and 7
VINCRISTINE 1.5 mg/m2/d, days 1 and 8
METHOTREXATE 5 g/m2 24 h infusion + AF, day 1
ARA-C 1 g/m2 i.v/12 h, days 5 and 6
DAUNORUBICINE 30 mg/m2 i.v.day 1
L-ASPARAGINASE 20.000 u/m2/d, i.m. or i.v. day 7
INTRATHECAL CHEMOTHERAPY day 1
Patients with CR and MRD negative, follow chemotherapy. Patients with MDR >0.01% after second cycle or considered previously MRD are candidates to allogenic transplantation after second cycle.
REINDUCTION/INTENSIFICATION TREATMENT (R.I.)
PREDNISOLONE 60 mg/m2/d, oral x 14 days (1-14) 30 mg/m2/d, oral x 7 days (15-22)
VINCRISTINE 1.5 mg/m2, i.v. x 2 days 1 and 8
DAUNORUBICINE 30 mg/m2 i.v x 2 , days 1 and 8
CYCLOPHOSPHAMIDE 500 mg/m2 I.V. day 15
-----------------------------------------
METHOTREXATE 3 g/m2 /24 h infusion + AF day 29
MERCAPTOPURINE 50 mg/m2/d, oral, days 29-35 and 43-50
ARA-C 1 g/m2/12 h., i.v., days 43 and 44
INTRATHECAL CHEMOTHERAPY , days 1, 15, 29 and 43
MAINTENANACE TREATMENT (M1)
Six cycles of:
MERCAPTOPURINE 50 mg/m2/d, oral x 21 days (1-21)
METHOTREXATE 20 mg/m2/d, i.m. /week x 3 (1,7,14)
PREDNISOLONE 60 mg/m2/d, oral x 7 days (22-28)
VINCRISTINE 1.5 mg/m2 i.v.day 22
ASPARAGINASE 20.000 u/m2 i.m. day 22
INTRATHECAL CHEMOTHERAPY day 22
MAINTENANCE TREATMENT (M2)
Diary mercaptopurine and weekly methotrexate at previous doses, until complete 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- High risk children with acute lymphoblastic leukemia
Key exclusion criteria (8 listed)
- Mature B-ALL (FABL3)
- Mixed forms of ALL
- Patients with coronary disorders, valvular or hypertensive cardiopathy
- Patients with chronic liver disorders
- Chronic pulmonary disorders
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 |
|---|---|---|
| PrednisoloneInduction: 60 mg/m2/day, oral or i.v x 21 days and 30 mg/m2/day oral or iv x 7 days Reinduction-Intensification Treatment: 60 mg/m2/d x 14 days and 30 mg/m2/day oral x 7 days | Drug | – |
| DaunorubicinInduction: 30 mg/m2, i.v, days 1, 8, 15, 22 Consolidation (Bloc II)30 mg/m2, i.v, day 1 | Drug | – |
| VincristineInduction: 1,5 mg/m2 iv, days 1, 8, 15, 22 Consolidation (Bloc I):1,5 mg/m2 iv, days 1, 8 Consolidation (Bloc II):1,5 mg/m2 iv, days 1, 8 Reinduction: 1,5 mg/m2 iv, days 1, 8 Maintenance:1,5 mg/m2 iv, day 22 | Drug | – |
| L-AsparaginaseInduction: 10.000 U/m2 im or iv, days 9,11,13,16,18,20,23,25,27 Consolidation (Bloc II): 20.000 U/m2 im or iv, day 7 Maintenance: 20.000 U/m2 im or iv, day 22 | Drug | – |
| CyclophosphamideInduction: 500 mg/m2 iv, days 1, 2, 29 Consolidation (Bloc I): 500 mg/m2 iv, day 8 Reinduction:500 mg/m2 iv, day 15 | Drug | – |
| MethotrexateConsolidation (Bloc I): 5 g/m2 24 hours infusion Consolidation (Bloc II): 5 g/m2 24 hours infusion Reinduction: 3 g/m2 24 hours infusion Maintenance: 20 mg/m2/d, IM/week x 3 (1, 7, 14) | Drug | – |
| Cytosine ArabinosideConsolidation (Bloc I): 1 g/m2/12 h iv, days 5, 6 Consolidation (Bloc II): 1 g/m2/12 h iv, days 5, 6 Reinduction: 1 g/m2/12 h iv, days 43, 44 | Drug | – |
Primary outcome
To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time
Time frame: 2 years
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 28 Oct 2014.
- 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.
Bastida Pilar, Dr study chair
Hospital Universitari Materno-Infantil Vall d'Hebron
Ribera Josep Mª, Dr study chair
Germans Trias i Pujol Hospital
4 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 Prednisolone, Daunorubicin and Vincristine in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 4 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 1 inclusion and 8 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time (time frame: 2 years). 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 28 Oct 2014.