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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00795756
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : October 22, 2014
Information provided by (Responsible Party):
DR RENATO BASSAN, Northern Italy Leukemia Group

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Comparative analysis of feasibility/toxicity of IT DepoCyte vs. TIT [ Time Frame: weeks 5, 11, 17 and 23 ]

Secondary Outcome Measures :
  1. Comparative analysis of isolated and combined CNS recurrence following TIT vs DepoCyte prophylaxis [ Time Frame: During study follow-up ]
  2. Complete remission (CR) [ Time Frame: After study chemotherapy cycles 1 and 2 ]
  3. Bone marrow MRD negativity rates [ Time Frame: Four time-points at weeks 4-22 ]
  4. Lenght of remission [ Time Frame: Study follow-up ]
  5. Overall survival [ Time Frame: Study follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00795756

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USC Ematologia, Ospedale Civile
Alessandria, (al), Italy
USC Ematologia, Ospedali Riuniti
Bergamo, (bg), Italy, 24128
Divisione di Ematologia - Spedali Civili
Brescia, (bs), Italy
Divisione di Ematologia e TMO, Ospedale San Maurizio
Bolzano, (bz), Italy
Ematologia e centro TMO - Ospedale Armando Businco
Cagliari, (ca), Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, (cn), Italy
Ematologia e centro TMO, Istituti Ospedalieri
Cremona, (cr), Italy
Ematologia - AOU Careggi
Firenze, (fi), Italy
Ematologia e centro TMO - IRCSS Mangiagalli Regina Elena
Milano, (mi), Italy
Ematologia e centro TMO, Ospedale San Raffaele
Milano, (mi), Italy
Ematologia e centro TMO, Ospedale San Gerardo
Monza, (mi), Italy
Oncoematologia e TMO - Dipartimento Oncologico La Maddalena
Palermo, (pa), Italy
Ematologia 2 - Ospedale San Giovanni Battista
Torino, (to), Italy
Medicina Interna I - Ospedale di Circolo
Varese, (va), Italy
Onco-Ematologia - Ospedale Civile
Noale, (ve), Italy
Ematologia - Ospedale San Bortolo
Vicenza, (vi), Italy
Sponsors and Collaborators
Northern Italy Leukemia Group
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Study Chair: Renato Bassan, MD USC Ematologia, Ospedali Riuniti, Bergamo (Italy)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: DR RENATO BASSAN, Medical Doctor, Northern Italy Leukemia Group Identifier: NCT00795756    
Other Study ID Numbers: NILG-ALL 10/07
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Keywords provided by DR RENATO BASSAN, Northern Italy Leukemia Group:
Central nervous system prophylaxis
Minimal residual disease
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antiviral Agents
Anti-Infective Agents