Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Northern Italy Leukemia Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Northern Italy Leukemia Group
ClinicalTrials.gov Identifier:
NCT00795756
First received: November 19, 2008
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

The aim of this clinical study in adult ALL is to compare by risk category (1) the feasibility of two different CNS prophylaxis regimens and (2) the overall disease-free survival in relation to the achievement of an early MRD negative status and following consolidation with lineage-targeted methotrexate infusions and other disease-specific therapeutic elements, with or without the application of allogeneic or autologous SCT depending on risk class and MRD study results.

In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all patients receive induction/consolidation therapy incorporating lineage-targeted high-dose methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final consolidation phase.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: liposome-encapsulated cytarabine (DepoCyte)
Drug: Triple intrathecal therapy (TIT)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study on CNS Prophylaxis With Liposome-Encapsulated Cytarabine in Association With a Lineage-Targeted and MRD-Oriented Postremission Strategy in Adult ALL

Resource links provided by NLM:


Further study details as provided by Northern Italy Leukemia Group:

Primary Outcome Measures:
  • Comparative analysis of feasibility/toxicity of IT DepoCyte vs. TIT [ Time Frame: weeks 5, 11, 17 and 23 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparative analysis of isolated and combined CNS recurrence following TIT vs DepoCyte prophylaxis [ Time Frame: During study follow-up ] [ Designated as safety issue: No ]
  • Complete remission (CR) [ Time Frame: After study chemotherapy cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Bone marrow MRD negativity rates [ Time Frame: Four time-points at weeks 4-22 ] [ Designated as safety issue: No ]
  • Lenght of remission [ Time Frame: Study follow-up ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Study follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intrathecal DepoCyte
I.t. DepoCyte 50 mg admninistered x6-8 (depending on immunophenotypic disease subset) during induction/consolidation/eraly maintenance phases
Drug: liposome-encapsulated cytarabine (DepoCyte)
DepoCyte 50 mg injected intrathecally x6-8 (6: B-lineage, 8: T-lineage) during induction/consolidation phases
Other Names:
  • DepoCyte
  • DepoCyt
Active Comparator: Triple intrathecal therapy (TIT)
Methotrexate 12,5 mg + Cytarabine 50 mg + Prednisolone 40 mg injected intrathecally x12 during indiction/consolidation phases
Drug: Triple intrathecal therapy (TIT)
Methotrexate 12,5 mg + Cytarabine 50 mg + Prednisolone 40 mg. injected intrathecally x12 during induction/consolidation therapy
Other Names:
  • Methotrexate
  • Cytosine arabinoside
  • Cytosar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years.
  • Diagnosis of untreated ALL with B-/T-precursor phenotype or B-cell lymphoblastic lymphoma (B-LL), either de novo or secondary to chemo-radiotherapy for other cancer.
  • Full cytological, cytochemical, cytogenetic and immunobiological disease characterization by revised FAB, EGIL and WHO criteria.
  • Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) for MRD study.
  • ECOG performance status 0-2 or reversible ECOG 3 score following intensive care of complications.
  • Signed informed consent.

Exclusion Criteria:

  • Diagnosis of B-ALL (FAB L3 ALL/Burkitt's leukemia or lymphoma) and T-LL (T-cell lymphoblastic lymphoma).
  • Down's syndrome.
  • Pre-existing, uncontrolled pathology such as cardiac disease (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL/LL), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL/LL), and severe neurological or psychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan.
  • Known HIV positive serology.
  • Other active hematological or non-hematological cancer with life expectancy <1 year.
  • Pregnancy (fertile women will be advised not to become pregnant while on treatment; and male patients to adopt contraceptive methods), unless therapeutic aborption/early discharge is carried out.
  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: NCT00795756

Contacts
Contact: Roberto Marchioli, MD 0039-(0)872-570250 marchioli@negrisud.it

Locations
Italy
USC Ematologia, Ospedale Civile Active, not recruiting
Alessandria, (al), Italy
USC Ematologia, Ospedali Riuniti Recruiting
Bergamo, (bg), Italy, 24128
Contact: Renato Bassan, MD    0039-(0)35-269492    rbassan@ospedaliriuniti.bergamo.it   
Principal Investigator: Renato Bassan, MD         
Sub-Investigator: Tamara Intermesoli, MD         
Sub-Investigator: Alessandro Rambaldi, MD         
Sub-Investigator: Orietta Spinelli, B. Sci.         
Divisione di Ematologia - Spedali Civili Not yet recruiting
Brescia, (bs), Italy
Contact: Giuseppe Rossi, MD         
Principal Investigator: Giuseppe Rossi, MD         
Sub-Investigator: Erika Borlenghi, MD         
Divisione di Ematologia e TMO, Ospedale San Maurizio Recruiting
Bolzano, (bz), Italy
Contact: Sergio Cortelazzo, MD         
Principal Investigator: Sergio Cortelazzo, MD         
Sub-Investigator: Irene Cavattoni, MD         
Sub-Investigator: Vincenzo Cassibba, MD         
Ematologia e centro TMO - Ospedale Armando Businco Not yet recruiting
Cagliari, (ca), Italy
Contact: Emanuele Angelucci, MD         
Principal Investigator: Emanuele Angelucci, MD         
Sub-Investigator: Claudio Romani, MD         
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle Recruiting
Cuneo, (cn), Italy
Contact: Daniele Mattei, MD         
Principal Investigator: Daniele Mattei, MD         
Sub-Investigator: Andrea Gallamini, MD         
Ematologia e centro TMO, Istituti Ospedalieri Not yet recruiting
Cremona, (cr), Italy
Contact: Sergio Morandi, MD         
Principal Investigator: Sergio Morandi, MD         
Ematologia - AOU Careggi Not yet recruiting
Firenze, (fi), Italy
Contact: Alberto Bosi, MD         
Sub-Investigator: Franco Leoni, MD         
Sub-Investigator: Giacomo Gianfaldoni, MD         
Sub-Investigator: Francesco Mannelli, MD         
Principal Investigator: Alberto Bosi, MD         
Ematologia e centro TMO - IRCSS Mangiagalli Regina Elena Recruiting
Milano, (mi), Italy
Contact: Giorgio Lambertenghi-Deliliers, MD         
Principal Investigator: Giorgio Lambertenghi-Deliliers, MD         
Sub-Investigator: Agostino Cortelezzi, MD         
Sub-Investigator: Angelo Cardellini, MD         
Ematologia e centro TMO, Ospedale San Raffaele Recruiting
Milano, (mi), Italy
Contact: Fabio Ciceri, MD         
Principal Investigator: Fabio Ciceri, MD         
Sub-Investigator: Stefania Trinca, MD         
Ematologia e centro TMO, Ospedale San Gerardo Recruiting
Monza, (mi), Italy
Contact: Enrico Pogliani, MD         
Principal Investigator: Enrico Pogliani, MD         
Sub-Investigator: Elisabetta Terruzzi, MD         
Sub-Investigator: Monica Fumagalli, MD         
Sub-Investigator: Luisa Verga, MD         
Oncoematologia e TMO - Dipartimento Oncologico La Maddalena Not yet recruiting
Palermo, (pa), Italy
Contact: Maurizio Musso, MD         
Principal Investigator: Maurizio Musso, MD         
Ematologia 2 - Ospedale San Giovanni Battista Recruiting
Torino, (to), Italy
Contact: Filippo Marmont, MD         
Principal Investigator: Filippo Marmont, MD         
Sub-Investigator: Ernesta Audisio, MD         
Medicina Interna I - Ospedale di Circolo Not yet recruiting
Varese, (va), Italy
Contact: Leonardo Campiotti, MD         
Principal Investigator: Leonardo Campiotti, MD         
Onco-Ematologia - Ospedale Civile Not yet recruiting
Noale, (ve), Italy
Contact: Giovanni Bertoldero, MD         
Principal Investigator: Giovanni Bertoldero, MD         
Ematologia - Ospedale San Bortolo Recruiting
Vicenza, (vi), Italy
Contact: Eros Di Bona, MD         
Principal Investigator: Eros Di Bona, MD         
Sponsors and Collaborators
Northern Italy Leukemia Group
Investigators
Study Chair: Renato Bassan, MD USC Ematologia, Ospedali Riuniti, Bergamo (Italy)
  More Information

No publications provided

Responsible Party: Dr Renato Bassan, NILG-USC Ematologia, Ospedali Riuniti, Bergamo (Italy)
ClinicalTrials.gov Identifier: NCT00795756     History of Changes
Other Study ID Numbers: NILG-ALL 10/07
Study First Received: November 19, 2008
Last Updated: March 31, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Northern Italy Leukemia Group:
Adults
Central nervous system prophylaxis
Minimal residual disease

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Cytarabine
Methotrexate
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 10, 2014