Acute Lymphoblastic LeukemiaPhase 4NCT00526175
LAL-BR/2001: Study Treatment to Low Risk ALL
A Phase 4 study testing Prednisone, Vincristine and Daunorubicin in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 25 sites in Spain.
Trial summary
The purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Prednisone, Vincristine and Daunorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 150 participants
- Where
- 25 sitesSpain
- Study dates
- Jun 2001to Dec 2015
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously
Who cannot join
- Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])
- Mixed forms of ALL
- Acute Leukemia no differentiate
- Patients with coronary disorders, valvular or hypertensive cardiopathy
- Patients with chronic liver disorders
- Chronic pulmonary disorders
Show all 10Show fewer
- Renal insufficiency
- Neurologic disfunctions
- ECOG 3 and 4
- No signed consent form
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Complejo Hospitalario Universitario de Albacete
Albacete
Hospital General de Alicante
Alicante, Alicante
Hospital de Badalona Germans Trias i Pujol
Badalona
Hospital Valle Hebrón-Materno Infantil
Barcelona, Barcelona
Hospital de Sant Pau
Barcelona
Hospital del Mar
Barcelona
Basurtuko Ospitalea
Basurto
Complejo Hospitalario Reina Sofía
Córdoba, Córdoba
Hospital General de Guadalajara
Guadalajara
Complejo Hospitalario León
León
Hospital Clínico San Carlos de Madrid
Madrid, Madrid
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Málaga
Complejo Asistencial Son Dureta
Palma de Mallorca
Hospital Clinico Universitario
Salamanca
Hospital Clínico Universitario de Salamanca
Salamanca
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Hospital General de Segovia
Segovia
H.U. Virgen del Rocio
Seville
Hospital Joan XXIII
Tarragona, Tarragona
Hospital Clínic
Valencia, Valencia
Hospital La Fe
Valencia, Valencia
Hospital Universitario Dr. Peset
Valencia, Valencia
Hospital Arnau de Vilanova
Valencia
Hospital Clínico de Valladolid
Valladolid
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza
About this study
The purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease
Read the detailed description
REMISION INDUCTION
Systemic chemotherapy:
Prednisolone (PDN):
- 60 mg/m2 day, i.v. or p.o., days 1 to 27
- 30 mg/m2 day, i.v. or p.o., days 28 to 35
Vincristine (VCR): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. Daunorubicin (DNR): 30 mg/m2, i.v., days 8 and 15. L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25.
Cyclophosphamide (CFM): 1000 mg/m2, i.v., day 22.
Intracranial chemotherapy
Methotrexate (MTX), cytosine (ARA-C) and hydrocortisone, days 1 and 22
CONSOLIDATION TREATMENT (WEEKS 6 TO 14)with INTENSIFICACIÓN (C-1)
- Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
- MTX: 3g/m2, i.v., in 24 hours, days 1, 28 and 56.
- VP-16: 150 mg/m2 i.v., days 14-15 and 42-43
- ARA-C: 1000 mg/m2 i.v., in 3 hours, days 14-15 and 42-43
- Intrathecal treatment, days 1, 28 and 56.
REINDUCTION-CONSOLIDATION TREATMENT (R-C) (WEEKS 15 TO 23)
Dexamethasone (DXM):
- 6 mg/m2 day, p.o., days 1-21
- 3 mg/m2 day, p.o. or i.v., days 22-28 VCR: 1,5 mg/m2, i.v., days 1, 8 and 15 DNR: 30 mg/m2, i.v., days 1 and 8 L-ASA: 10.000 UI/m2 i.m. or i.v., days 8 and 9, 15 and 16, 22 and 23. CFM 1000 mg/m2 day, i.v., day 22 Mercaptopurine (MP) 50 mg/m2, p.o., days 35-42 MTX: 3g/m2, i.v., in 24 hours, day 35. VP-16: 150 mg/m2 i.v., days 49-50 ARA-C: 1.000 mg/m2 i.v., in 3 hours, days 49-50 Intrathecal treatment days 1 and 35.
MAINTENANCE TREATMENT (M-1)
Continuous treatment
- MP 50 mg/m2/day, p.o.
- MTX 20 mg/m2/week, i.m.
Reinductions
- VCR: 1,5 mg/m2 i.v., day 1.
- PDN: 30 mg/m2/day, i.v. or p.o., days 1 to 7
- L-ASA: 20.000 UI/m2, i.m. or i.v., day 1.
- Intrathecal treatment day 1 Five cycles, weeks 24, 30, 36, 42 and 48. During the week of administration cycle, continuous chemotherapy should be suspended.
Intrathecal treatment: At the start of any reinduction cycle
MAINTENANCE TREATMENT (M-2) (WEEKS 55-108)
- MP 50 mg/m2/day, p.o.
- MTX 20 mg/m2/week, i.m.
- Intrathecal treatment, weeks 54 and 108
At the end of treatment should be done the study of MRD (flux cytometry)
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Prednisone, Vincristine, Daunorubicin, L-Asparaginase, Cyclophosphamide
- Keywords
- Acute Lymphoblastic Leukemia, Minimal Residual Disease
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
60 mg/m2 day, i.v. or oral, dyas 1 to 27 30 mg/m2 day, i.v. or oral, days 28 to 35
VincristineDrug
1,5 mg/m2 i.v., days 8, 15, 22 and 28
DaunorubicinDrug
30 mg/m2, i.v., days 8 and 15
L-AsparaginaseDrug
10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Total: 9 doses.
CyclophosphamideDrug
1000 mg/m2, i.v., day 22.
MethotrexateDrug
Age <1 year 1-2 years 2-3 years > 3 years MTX 5 mg 8 mg 10 mg 12 mg
Cytosine ArabinosideDrug
Edad <1 year 1-2 years 2-3 years > 3 years ARA-C 16 mg 16 mg 20 mg 30 mg
MercaptopurineDrug
50 mg/m2,oral, days 1 to 7, 28-35 and 56-63
VP-16Drug
150 mg/m2 i.v., days 14-15 and 42-43
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival
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 2001
- Primary completionMay 2015
- Study completionDec 2015
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ribera Josep Mª, Dr, Study chair, Germans Trias i Pujol HospitalBastida Pilar, Dr, Study chair, Hospital Materno-Infantil Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526175
- Sponsor's protocol ID
- LAL-BR/2001
- Status last verified
- Jan 2016
- First submitted
- 6 Sep 2007
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAL-BR/2001: Study Treatment to Low Risk ALL
- ClinicalTrials.gov ID
- NCT00526175
- Acronym / sponsor ID
- LAL-BR/2001
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, Minimal Residual Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (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 purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease
Detailed description
REMISION INDUCTION
Systemic chemotherapy:
Prednisolone (PDN):
- 60 mg/m2 day, i.v. or p.o., days 1 to 27
- 30 mg/m2 day, i.v. or p.o., days 28 to 35
Vincristine (VCR): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. Daunorubicin (DNR): 30 mg/m2, i.v., days 8 and 15. L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25.
Cyclophosphamide (CFM): 1000 mg/m2, i.v., day 22.
Intracranial chemotherapy
Methotrexate (MTX), cytosine (ARA-C) and hydrocortisone, days 1 and 22
CONSOLIDATION TREATMENT (WEEKS 6 TO 14)with INTENSIFICACIÓN (C-1)
- Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
- MTX: 3g/m2, i.v., in 24 hours, days 1, 28 and 56.
- VP-16: 150 mg/m2 i.v., days 14-15 and 42-43
- ARA-C: 1000 mg/m2 i.v., in 3 hours, days 14-15 and 42-43
- Intrathecal treatment, days 1, 28 and 56.
REINDUCTION-CONSOLIDATION TREATMENT (R-C) (WEEKS 15 TO 23)
Dexamethasone (DXM):
- 6 mg/m2 day, p.o., days 1-21
- 3 mg/m2 day, p.o. or i.v., days 22-28 VCR: 1,5 mg/m2, i.v., days 1, 8 and 15 DNR: 30 mg/m2, i.v., days 1 and 8 L-ASA: 10.000 UI/m2 i.m. or i.v., days 8 and 9, 15 and 16, 22 and 23. CFM 1000 mg/m2 day, i.v., day 22 Mercaptopurine (MP) 50 mg/m2, p.o., days 35-42 MTX: 3g/m2, i.v., in 24 hours, day 35. VP-16: 150 mg/m2 i.v., days 49-50 ARA-C: 1.000 mg/m2 i.v., in 3 hours, days 49-50 Intrathecal treatment days 1 and 35.
MAINTENANCE TREATMENT (M-1)
Continuous treatment
- MP 50 mg/m2/day, p.o.
- MTX 20 mg/m2/week, i.m.
Reinductions
- VCR: 1,5 mg/m2 i.v., day 1.
- PDN: 30 mg/m2/day, i.v. or p.o., days 1 to 7
- L-ASA: 20.000 UI/m2, i.m. or i.v., day 1.
- Intrathecal treatment day 1 Five cycles, weeks 24, 30, 36, 42 and 48. During the week of administration cycle, continuous chemotherapy should be suspended.
Intrathecal treatment: At the start of any reinduction cycle
MAINTENANCE TREATMENT (M-2) (WEEKS 55-108)
- MP 50 mg/m2/day, p.o.
- MTX 20 mg/m2/week, i.m.
- Intrathecal treatment, weeks 54 and 108
At the end of treatment should be done the study of MRD (flux cytometry)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously
Key exclusion criteria (10 listed)
- Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])
- Mixed forms of ALL
- Acute Leukemia no differentiate
- Patients with coronary disorders, valvular or hypertensive cardiopathy
- Patients with chronic liver 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 |
|---|---|---|
| Prednisone60 mg/m2 day, i.v. or oral, dyas 1 to 27 30 mg/m2 day, i.v. or oral, days 28 to 35 | Drug | – |
| Vincristine1,5 mg/m2 i.v., days 8, 15, 22 and 28 | Drug | – |
| Daunorubicin30 mg/m2, i.v., days 8 and 15 | Drug | – |
| L-Asparaginase10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Total: 9 doses. | Drug | – |
| Cyclophosphamide1000 mg/m2, i.v., day 22. | Drug | – |
| MethotrexateAge <1 year 1-2 years 2-3 years > 3 years MTX 5 mg 8 mg 10 mg 12 mg | Drug | – |
| Cytosine ArabinosideEdad <1 year 1-2 years 2-3 years > 3 years ARA-C 16 mg 16 mg 20 mg 30 mg | Drug | – |
| Mercaptopurine50 mg/m2,oral, days 1 to 7, 28-35 and 56-63 | Drug | – |
| VP-16150 mg/m2 i.v., days 14-15 and 42-43 | Drug | – |
Primary outcome
To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival
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 20 Jan 2016.
- 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.
Ribera Josep Mª, Dr study chair
Germans Trias i Pujol Hospital
Bastida Pilar, Dr study chair
Hospital Materno-Infantil Vall d'Hebron
25 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 Prednisone, Vincristine and Daunorubicin in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 25 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 10 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival (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 20 Jan 2016.