Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia (LAL1308)
This study is ongoing, but not recruiting participants.
Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01156883
First received: July 2, 2010
Last updated: July 14, 2016
Last verified: July 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Leukemia |
Drug: 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Mercaptopurine
Prednisone
Methotrexate
Methylprednisolone
Cytarabine
Thioguanine
Vincristine sulfate
Ifosfamide
Asparaginase
Daunorubicin
Doxorubicin
Daunorubicin hydrochloride
Doxorubicin hydrochloride
U.S. FDA Resources
Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Primary Outcome Measures:
- Treatment feasibility [ Time Frame: At 24 months from study entry. ] [ Designated as safety issue: No ]To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.
Secondary Outcome Measures:
- Disease free survival [ Time Frame: At three years from study entry ] [ Designated as safety issue: No ]Estimation of Disease Free Survival (DFS).
- Event free survival [ Time Frame: At 3 years from study entry ] [ Designated as safety issue: No ]Estimation of Event Free Survival (EFS).
- Overal survival [ Time Frame: At 3 years from study entry ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: At 3 years from study entry ] [ Designated as safety issue: Yes ]Grade III-IV toxicity events
- Compliance [ Time Frame: At 3 years from study entry ] [ Designated as safety issue: No ]Therapy compliance
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | February 2017 |
| Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 34 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156883
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156883
Locations
| Italy | |
| Complesso Ospedaliero S. Giovanni Addolorata | |
| Roma, (rm), Italy, 00184 | |
| Azienda Ospedaliera - Nuovo Ospedale "Torrette" | |
| Ancona, Italy | |
| USL 8 - Ospedale S.Donato | |
| Arezzo, Italy | |
| Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni" | |
| Ascoli, Italy | |
| Az.Ospedaliera S.G.Moscati | |
| Avellino, Italy | |
| UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari | |
| Bari, Italy | |
| Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi | |
| Bologna, Italy | |
| Divisione di Ematologia Ospedale A. Perrino | |
| Brindisi, Italy | |
| Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" | |
| Catania, Italy | |
| Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia | |
| Catanzaro, Italy | |
| Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna | |
| Ferrara, Italy | |
| Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino" | |
| Genova, Italy | |
| ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE | |
| Lecce, Italy | |
| Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" | |
| Messina, Italy | |
| Ospedale Niguarda " Ca Granda" | |
| Milano, Italy | |
| Centro Oncologico Modenese - Dipartimento di Oncoematologia | |
| Modena, Italy | |
| Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" | |
| Napoli, Italy | |
| UOSC di Ematologia Oncologica - Istituto Nazionale Tumori "Fondazione Senatore Giovanni Pascale" | |
| Napoli, Italy | |
| zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia | |
| Napoli, Italy | |
| Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I | |
| Nocera Inferiore, Italy | |
| S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro | |
| Novara, Italy | |
| Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone" | |
| Palermo, Italy | |
| Ospedali Riuniti "Villa Sofia-Cervello" | |
| Palermo, Italy | |
| Cattedra di Ematologia CTMO Università degli Studi di Parma | |
| Parma, Italy | |
| S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo | |
| Pavia, Italy | |
| U.O. Ematologia Clinica - Azienda USL di Pescara | |
| Pescara, Italy | |
| Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia | |
| Pisa, Italy | |
| Dipartimento Oncologico - Ospedale S.Maria delle Croci | |
| Ravenna, Italy | |
| Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" | |
| Reggio Calabria, Italy | |
| Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova | |
| Reggio Emilia, Italy | |
| Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia | |
| Roma, Italy | |
| Divisione di Ematologia - Ospedale S. Camillo Divisione di Ematologia - Ospedale S. Camillo | |
| Roma, Italy | |
| Divisione Ematologia - Università Campus Bio-Medico | |
| Roma, Italy | |
| S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena | |
| Roma, Italy | |
| U.O.C. Ematologia - Ospedale S.Eugenio | |
| Roma, Italy | |
| Università Cattolica del Sacro Cuore - Policlinico A. Gemelli | |
| Roma, Italy | |
| Università degli Studi - Policlinico di Tor Vergata | |
| Roma, Italy | |
| Universita Degli Studi "La Sapeinza" | |
| Rome, Italy, 00161 | |
| Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza | |
| S. G. Rotondo, Italy | |
| Serv. di Ematologia Ist. di Ematologia ed Endocrinologia | |
| Sassari, Italy | |
| Struttura Complessa Ematologia - Azienda Sanitaria Locale BAT1- Presidio Ospedaliero Bisceglie-Trani | |
| Trani, Italy | |
| Clinica Ematologica - Policlinico Universitario | |
| Udine, Italy | |
| Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi | |
| Verona, Italy | |
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
| Principal Investigator: | Roberto Foa, MD | Universita Degli Studi "La Sapeinza" |
More Information
| Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| ClinicalTrials.gov Identifier: | NCT01156883 History of Changes |
| Other Study ID Numbers: | LAL1308 GIMEMA-LAL1308 EU-21042 |
| Study First Received: | July 2, 2010 |
| Last Updated: | July 14, 2016 |
| Health Authority: | Italy: Ethics Committee |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
|
B-cell adult acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia T-cell adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisolone acetate Methylprednisolone acetate Dexamethasone Prednisone Methylprednisolone Methylprednisolone Hemisuccinate |
Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Liposomal doxorubicin Cyclophosphamide Methotrexate Doxorubicin Cytarabine Vincristine Ifosfamide 6-Mercaptopurine Daunorubicin Asparaginase Thioguanine Vindesine |
ClinicalTrials.gov processed this record on September 23, 2016