Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia (LAL1308)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01156883
First received: July 2, 2010
Last updated: April 21, 2015
Last verified: April 2015
  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:


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 2016
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
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

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
Università degli Studi - Policlinico di Tor Vergata
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
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
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

Additional Information:
No publications provided

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: April 21, 2015
Health Authority: Italy: Ethics Committee

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
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Daunorubicin
Doxorubicin
Liposomal doxorubicin
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Vincristine
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2015