Leukemia, Lymphocytic, AcuteLAL2000NCT00537550
Adult ALL Treatment at Diagnosis
A study testing Vincristine and Vincristin, Daunorubicine, Asparaginase, Methotrexate in people with Leukemia, Lymphocytic, Acute, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 5 sites in Italy.
Trial summary
The present study has been designed to give participating centers the possibility of better understanding the diagnostic and prognostic factors of ALL patients. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Leukemia, Lymphocytic, Acute
- What is being tested?
- Vincristine and Vincristin, Daunorubicine, Asparaginase, Methotrexate
- How many people
- Not given
- Where
- 5 sitesItaly
- Study dates
- Jul 2000to Jun 2006
- Phase
- Interventional
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of acute lymphoblastic leukemia (ALL)
- Negative myeloperoxidase stain
- Phenotype T (ALL-T) and B(ALL-B)
Who cannot join
- Creatinine > 2.5mg/dL after adequate hydratation
- LVEF <50%
- Presence of documented infections not responding to antibiotic and/or antifungal therapy
- Presence of concomitant malignant diseases
- Absence of any psychological condition that does not allow to intake high doses of cortisone
- Patients who have received any antineoplastic chemiotherapy for more than 5 days
- Patients who have received any steroids for more than 10 days
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Az. Ospedaliera S. G. Moscati
Avellino
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna
Ospedale Reg. A di Summa
Brindisi
Istituto di Ematologia- Ospedale San Carlo
Potenza
Policlinico G.B. Rossi
Verona, 37134
About this study
Official title: GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis
The present study has been designed to give participating centers the possibility of better understanding the diagnostic and prognostic factors of ALL patients.
- Conditions
- Leukemia, Lymphocytic, Acute
- Being tested
- Vincristine, Vincristin, Daunorubicine, Asparaginase, Methotrexate
- Keywords
- ALL, Adult
- 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
Steroids pre-treatment
Vincristin, Daunorubicine, Asparaginase, MethotrexateDrug
Induction therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startJul 2000
- Study completionJun 2006
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 Leukemia, Lymphocytic, AcuteStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Investigators
- Franco MANDELLI, Pr, Principal investigator, Università degli Studi di Roma "La Sapienza"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537550
- Sponsor's protocol ID
- LAL2000
- Acronym
- LAL2000
- Status last verified
- Sep 2007
- First submitted
- 27 Sep 2007
- Last updated
- 1 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.
PubMed 34048072
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis
- ClinicalTrials.gov ID
- NCT00537550
- Acronym / sponsor ID
- LAL2000 / LAL2000
- Conditions
- Leukemia, Lymphocytic, Acute
- Keywords
- ALL, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Jul 2000
- Study completion
- Jun 2006 (actual)
- First posted
- 1 Oct 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 present study has been designed to give participating centers the possibility of better understanding the diagnostic and prognostic factors of ALL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of acute lymphoblastic leukemia (ALL)
- Negative myeloperoxidase stain
- Phenotype T (ALL-T) and B(ALL-B)
Key exclusion criteria (7 listed)
- Creatinine > 2.5mg/dL after adequate hydratation
- LVEF <50%
- Presence of documented infections not responding to antibiotic and/or antifungal therapy
- Presence of concomitant malignant diseases
- Absence of any psychological condition that does not allow to intake high doses of cortisone
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 |
|---|---|---|
| VincristineSteroids pre-treatment | Drug | – |
| Vincristin, Daunorubicine, Asparaginase, MethotrexateInduction therapy | Drug | – |
Primary outcome
Not reported in the source record.
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 1 Oct 2007.
- Derived from this study: PubMed 34048072Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.
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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.
Franco MANDELLI, Pr principal investigator
Università degli Studi di Roma "La Sapienza"
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vincristine and Vincristin, Daunorubicine, Asparaginase, Methotrexate in people with Leukemia, Lymphocytic, Acute, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 5 sites in Italy.
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 3 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 1 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00537550, 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 1 Oct 2007.