LeukemiaLAL1308NCT01156883
Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia
A study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 43 sites in Italy.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with steroid therapy may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Leukemia
- What is being tested?
- asparaginase, cyclophosphamide and cytarabine
- How many people
- 76 participants
- Where
- 43 sitesItaly
- Study dates
- Apr 2010to 31 Oct 2017
- 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 18 to 34 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoid leukemia, meeting any of the following criteria:
- Non-mature B-cell disease
- Non-Philadelphia chromosome positive disease
- T -cell or B-cell phenotype
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Prior pretreatment with antiblastic chemotherapy allowed
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Italy43 sites
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona
USL 8 - Ospedale S.Donato
Arezzo
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
Ascoli Piceno
Az.Ospedaliera S.G.Moscati
Avellino
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Bari
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna
Divisione di Ematologia Ospedale A. Perrino
Brindisi
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro
Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
Ferrara
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
Genova
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina
Ospedale Niguarda " Ca Granda"
Milan
Centro Oncologico Modenese - Dipartimento di Oncoematologia
Modena
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Naples
UOSC di Ematologia Oncologica - Istituto Nazionale Tumori "Fondazione Senatore Giovanni Pascale"
Naples
zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Naples
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
Nocera Inferiore
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
Pavia
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
Pisa
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia
Complesso Ospedaliero S. Giovanni Addolorata
Roma, (RM), 00184
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma
Divisione di Ematologia - Ospedale S. Camillo Divisione di Ematologia - Ospedale S. Camillo
Roma
Divisione Ematologia - Università Campus Bio-Medico
Roma
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
Roma
U.O.C. Ematologia - Ospedale S.Eugenio
Roma
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
Università degli Studi - Policlinico di Tor Vergata
Roma
Universita Degli Studi "La Sapeinza"
Rome, 00161
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
Sassari
Struttura Complessa Ematologia - Azienda Sanitaria Locale BAT1- Presidio Ospedaliero Bisceglie-Trani
Trani
Clinica Ematologica - Policlinico Universitario
Udine
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona
About this study
Official title: Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with steroid therapy may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in treating young adult patients with acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
- To determine the feasibility of combination chemotherapy in young adult patients with acute lymphoid leukemia.
- To determine the complete response rate at the end of induction therapy in these patients.
- To determine the overall survival of patients treated with these regimens.
- To determine the disease-free survival of patients treated with these regimens.
- To determine the event-free survival of patients treated with these regimens.
- To determine toxicity of these regimens.
- To determine compliance related to dose intensity.
OUTLINE:
- Steroids prephase therapy: All patients receive steroids (i.e., prednisone or methylprednisolone) and methotrexate.
- Induction therapy (induction Ia followed by Ib): Patients receive induction Ia comprising vincristine, daunorubicin hydrochloride, asparaginase, and prednisone. They then receive induction Ib comprising cyclophosphamide, mercaptopurine, and cytarabine. Patients who achieve hematological remission proceed to consolidation therapy.
- Consolidation therapy: Patients receive consolidation therapy according to risk group.
- Standard-risk patients: Patients receive high-dose methotrexate and mercaptopurine.
- High-risk patients: Patients receive consolidation therapy in 3 steps.
- Step 1: Patients receive dexamethasone, vincristine, methotrexate, cytarabine, and asparaginase.
- Step 2: Patients receive dexamethasone, vindesine, methotrexate, ifosfamide, asparaginase, and daunorubicin hydrochloride.
- Step 3: Patients receive dexamethasone, cytarabine, and asparaginase. After completion of consolidation therapy, patients proceed to reinduction therapy.
- Reinduction therapy (reinduction IIa followed by IIb): Patients receive reinduction IIa comprising vincristine, doxorubicin hydrochloride, asparaginase, and dexamethasone. Patients then receive reinduction IIb comprising cyclophosphamide, thioguanine, and cytarabine.
- Conditions
- Leukemia
- Being tested
- asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone
- Keywords
- B-cell adult acute lymphoblastic leukemia, recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asparaginaseDrug
cyclophosphamideDrug
cytarabineDrug
daunorubicin hydrochlorideDrug
dexamethasoneDrug
ifosfamideDrug
mercaptopurineDrug
methotrexateDrug
prednisoneDrug
thioguanineDrug
vindesineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment feasibility
To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.
Measured: At 24 months from study entry.
Secondary outcomes (5)
Disease free survival
Estimation of Disease Free Survival (DFS).
Measured: At three years from study entry
Event free survival
Estimation of Event Free Survival (EFS).
Measured: At 3 years from study entry
Overal survival
Measured: At 3 years from study entry
Safety
Grade III-IV toxicity events
Measured: At 3 years from study entry
Compliance
Therapy compliance
Measured: At 3 years from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startApr 2010
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Foa, MD, Principal investigator, Universita Degli Studi "La Sapeinza"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156883
- Sponsor's protocol ID
- LAL1308
- Other IDs
- GIMEMA-LAL1308, EU-21042
- Acronym
- LAL1308
- Status last verified
- Sep 2021
- First submitted
- 2 Jul 2010
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment
- ClinicalTrials.gov ID
- NCT01156883
- Acronym / sponsor ID
- LAL1308 / LAL1308
- Conditions
- Leukemia
- Keywords
- B-cell adult acute lymphoblastic leukemia, recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 5 Jul 2010 (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.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with steroid therapy may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in treating young adult patients with acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
- To determine the feasibility of combination chemotherapy in young adult patients with acute lymphoid leukemia.
- To determine the complete response rate at the end of induction therapy in these patients.
- To determine the overall survival of patients treated with these regimens.
- To determine the disease-free survival of patients treated with these regimens.
- To determine the event-free survival of patients treated with these regimens.
- To determine toxicity of these regimens.
- To determine compliance related to dose intensity.
OUTLINE:
- Steroids prephase therapy: All patients receive steroids (i.e., prednisone or methylprednisolone) and methotrexate.
- Induction therapy (induction Ia followed by Ib): Patients receive induction Ia comprising vincristine, daunorubicin hydrochloride, asparaginase, and prednisone. They then receive induction Ib comprising cyclophosphamide, mercaptopurine, and cytarabine. Patients who achieve hematological remission proceed to consolidation therapy.
- Consolidation therapy: Patients receive consolidation therapy according to risk group.
- Standard-risk patients: Patients receive high-dose methotrexate and mercaptopurine.
- High-risk patients: Patients receive consolidation therapy in 3 steps.
- Step 1: Patients receive dexamethasone, vincristine, methotrexate, cytarabine, and asparaginase.
- Step 2: Patients receive dexamethasone, vindesine, methotrexate, ifosfamide, asparaginase, and daunorubicin hydrochloride.
- Step 3: Patients receive dexamethasone, cytarabine, and asparaginase. After completion of consolidation therapy, patients proceed to reinduction therapy.
- Reinduction therapy (reinduction IIa followed by IIb): Patients receive reinduction IIa comprising vincristine, doxorubicin hydrochloride, asparaginase, and dexamethasone. Patients then receive reinduction IIb comprising cyclophosphamide, thioguanine, and cytarabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| asparaginase | Drug | – |
| cyclophosphamide | Drug | – |
| cytarabine | Drug | – |
| daunorubicin hydrochloride | Drug | – |
| dexamethasone | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| ifosfamide | Drug | – |
| mercaptopurine | Drug | – |
| methotrexate | Drug | – |
| methylprednisolone | Drug | – |
| prednisone | Drug | – |
| thioguanine | Drug | – |
| vincristine sulfate | Drug | – |
| vindesine | Drug | – |
Primary outcome
Treatment feasibility
Time frame: At 24 months from study entry.
To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.
5 secondary outcomes
Disease free survival
Time frame: At three years from study entry
Event free survival
Time frame: At 3 years from study entry
Overal survival
Time frame: At 3 years from study entry
Safety
Time frame: At 3 years from study entry
Compliance
Time frame: At 3 years from study entry
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 13 Sep 2021.
- 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.
- Individual participant dataSharing planned: No
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Roberto Foa, MD principal investigator
Universita Degli Studi "La Sapeinza"
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 43 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?
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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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.
What does the primary outcome measure?
Treatment feasibility (time frame: At 24 months from study entry.). 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 NCT01156883, 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 13 Sep 2021.