Acute Lymphoblastic LeukemiaPhase 4NCT00526305
LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
A Phase 4 study testing Vincristine, Daunorubicin and Prednisone in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 50 sites in Spain.
Trial summary
Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Vincristine, Daunorubicin and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- 50 sitesSpain
- Study dates
- Jan 2000to Apr 2005
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ALL BCR/ABL+ patients Age < 65 years No previous treatment
Who cannot join
- Other LLA variability
- Previous history of coronary valvular, hypertensive cardiopathy illness
- Chronic hepatic illness
- Chronic respiratory insufficiency
- Renal insufficiency not caused by LLA
- Severe neurological problems not caused by LLA
- Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
Spain50 sites
Complejo Hospitalario Universitario de Albacete
Albacete
Hospital General de Alicante
Alicante, Alicante
Hospital Ntra. Sra. Sonsoles
Ávila, Avila
Hospital de Badalona Germans Trias i Pujol
Badalona
Hospital Clínic
Barcelona, Barcelona
Hospital del Mar
Barcelona, Barcelona
Hospital vall d'Hebrón
Barcelona, Barcelona
Hospital de Sant Pau
Barcelona
Basurtuko Ospitalea
Basurto
Hospital de Cruces
Bilbao
Hospital general de Castellón
Castelló, Castellón
Hospital de Jerez de la Frontera
Jerez de la Frontera
Complejo Hospitalario León
León
Hospital Arnau de Vilanova
Lleida, Lleida
Complexo Hospitalario Xeral-Calde
Lugo
Hospital Clínico San Carlos de Madrid
Madrid, Madrid
Hospital General Universitario Gregorio Marañón, Madrid
Madrid, Madrid
Hospital Universitario de la Princesa
Madrid, Madrid
Clínica Puerta de Hierro
Madrid
Hospital 12 de Octubre
Madrid
Hospital de la Princesa
Madrid
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Málaga
H. Carlos Haya
Málaga
Althaia, Xarxa Asistencial de Manresa
Manresa
Hospital General Universitario Morales Meseguer.
Murcia, Murcia
Hospital General Morales Meseguer
Murcia
Hospital Santa María del Rosell
Murcia
Hospital Central de Asturias
Oviedo, Principality of Asturias
Complejo Asistencial Son Dureta
Palma de Mallorca
Hospital Son Llatzer
Palma de Mallorca
Hospital de Navarra
Pamplona, Navarre
Clínica Universitaria de Navarra
Pamplona
Complejo Hospitalario de Pontevedra_Hospital Montecelo
Pontevedra
Corporació Sanitaria Parc Taulí
Sabadell
Hospital de Sagunto
Sagunto
Hospital Clínico Universitario de Salamanca
Salamanca
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Hospital General de Segovia
Segovia
H.U. Virgen del Rocio
Seville
Hospital Verge de la Cinta
Tortosa, Tarragona
Hospital Clínico Universitario de Valencia
Valencia, Valencia
Hospital Clínic
Valencia, Valencia
Hospital dr. Peset
Valencia, Valencia
Hospital General Universitario
Valencia, Valencia
Hospital La Fe
Valencia, Valencia
Hospital Clínico de Valladolid
Valladolid
Complejo Hospitalario Universitario de Vigo
Vigo
Hospital de Galdakao
Vizcaya
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza
About this study
Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
Read the detailed description
Remission Induction:
- Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
- Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
- Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
- L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13
Results:
- Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks
2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C
Intrathecal chemotherapy:
Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22
CONSOLIDATION TREATMENT 1
Start in two weeks after last dose of induction chemotherapy:
- Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
- Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
- VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
- ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
- Intrathecal treatment, days 28 and 56.
6.4. CONSOLIDATION TREATMENT 2
Start in a week after last dose of mercaptopurine of previous cycle
- Dexamethasone (DXM):
- 10 mg/m2 day, p.o. or i.v. days 1-14
- 5 mg/m2 day, p.o. or i.v., days 15-21
- Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
- Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
- CFM 600 mg/m2 day, i.v., days 1 and 15
- L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
- Intrathecal treatment days 1 and 15.
TRANSPLANTATION
Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.
Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1
Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Vincristine, Daunorubicin, Prednisone, L-Asparaginase, Mitoxantrone
- Keywords
- Acute Lymphoblastic Leukemia, Chromosome Philadelphia positive
- 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.
VincristineDrug
1,5 mg/m2 i.v., days 1 and 8
DaunorubicinDrug
60 mg/m2, i.v., days 1 and 8
PrednisoneDrug
60 mg/m2 day, i.v. or oral, days 1 to 14
L-AsparaginaseDrug
10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
MitoxantroneDrug
12 mg/m2 i.v days 15, 16 and 17
Cytosine ArabinosideDrug
1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)
HydrocortisoneDrug
10 mg ,15 mg or 20 mg depending of age
MercaptopurineDrug
50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
CyclophosphamideDrug
600 mg/m2 day, i.v., days 1 to 15 in consolidation
DexamethasoneDrug
10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21
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 overall survival
Measured: 5 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 startJan 2000
- Primary completionApr 2005
- Study completionApr 2005
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Ribera Josep Mª, Dr, Study chair, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526305
- Sponsor's protocol ID
- LAL-Ph-2000
- Status last verified
- Jan 2010
- First submitted
- 5 Sep 2007
- Last updated
- 5 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
- LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
- ClinicalTrials.gov ID
- NCT00526305
- Acronym / sponsor ID
- LAL-Ph-2000
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, Chromosome Philadelphia positive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (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.
Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
Detailed description
Remission Induction:
- Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
- Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
- Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
- L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13
Results:
- Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks
2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C
Intrathecal chemotherapy:
Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22
CONSOLIDATION TREATMENT 1
Start in two weeks after last dose of induction chemotherapy:
- Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
- Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
- VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
- ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
- Intrathecal treatment, days 28 and 56.
6.4. CONSOLIDATION TREATMENT 2
Start in a week after last dose of mercaptopurine of previous cycle
- Dexamethasone (DXM):
- 10 mg/m2 day, p.o. or i.v. days 1-14
- 5 mg/m2 day, p.o. or i.v., days 15-21
- Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
- Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
- CFM 600 mg/m2 day, i.v., days 1 and 15
- L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
- Intrathecal treatment days 1 and 15.
TRANSPLANTATION
Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.
Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1
Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ALL BCR/ABL+ patients Age < 65 years No previous treatment
Key exclusion criteria (7 listed)
- Other LLA variability
- Previous history of coronary valvular, hypertensive cardiopathy illness
- Chronic hepatic illness
- Chronic respiratory insufficiency
- Renal insufficiency not caused by LLA
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 |
|---|---|---|
| Vincristine1,5 mg/m2 i.v., days 1 and 8 | Drug | – |
| Daunorubicin60 mg/m2, i.v., days 1 and 8 | Drug | – |
| Prednisone60 mg/m2 day, i.v. or oral, days 1 to 14 | Drug | – |
| L-Asparaginase10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses. | Drug | – |
| Mitoxantrone12 mg/m2 i.v days 15, 16 and 17 | Drug | – |
| Cytosine Arabinoside1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses) | Drug | – |
| Hydrocortisone10 mg ,15 mg or 20 mg depending of age | Drug | – |
| Mercaptopurine50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation | Drug | – |
| Cyclophosphamide600 mg/m2 day, i.v., days 1 to 15 in consolidation | Drug | – |
| Dexamethasone10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21 | Drug | – |
Primary outcome
To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival
Time frame: 5 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 5 Jan 2010.
- 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
50 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 Vincristine, Daunorubicin and Prednisone in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 50 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 7 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 50 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 overall survival (time frame: 5 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 5 Jan 2010.