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Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT02036489
Recruitment Status : Recruiting
First Posted : January 15, 2014
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Brief Summary:
Understand the dynamics of elimination of MRD in adult patients with standard-risk LAL treated with a pediatric protocol.

Condition or disease Intervention/treatment Phase
Acute Lymphobkastic Leukemia Drug: Vincristine Drug: Daunorubicin Drug: Prednisone Drug: L-asparaginase Drug: Ciclophosphamide Drug: Metotrexate Drug: ARA-C Drug: Hidrocortisone Drug: Mercaptopurine Drug: VP-16 Drug: Dexametasone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute
Actual Study Start Date : January 2008
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: Induction and consolidation treatment Drug: Vincristine
Drug: Daunorubicin
Drug: Prednisone
Drug: L-asparaginase
Drug: Ciclophosphamide
Drug: Metotrexate
Drug: ARA-C
Drug: Hidrocortisone
Drug: Mercaptopurine
Drug: VP-16
Drug: Dexametasone



Primary Outcome Measures :
  1. Efficacy of treatment in adulta with standard risk acute lymphoblastic leukemia [ Time Frame: 2 years ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adults (age> 15 years) with ALL standard risk previously untreated. The LAL standard risk is defined by all of the following criteria:

  • Age less than 30 years
  • WBC <25x109 / L
  • Absence of cytogenetic alterations that misbehave forecast or t (9, 22) or demonstration of BCR-ABL rearrangement or alterations in 11q23, or demonstration ALL1-AF4 rearrangement (MLL)

Exclusion Criteria:

LAL L3 type mature phenotype B (sIg +) or with cytogenetic abnormalities characteristic of Burkitt LAL (t [8, 14], t [2, 8], t [8, 22]). For these patients have the BURKIMAB study.

  • LAL Ph (BCR-ABL) positive. These patients should be treated with imatinib associated with chemotherapy.
  • Biphenotypic acute leukemias and bilinear. For these patients treatment is recommended LAM own guidelines.
  • Acute undifferentiated leukemias. For these patients treatment is recommended LAM own guidelines.
  • Patients with a history of coronary artery disease, valvular or hypertensive heart disease.
  • Patients with chronic liver disease.
  • Patients with chronic respiratory failure.
  • Renal failure not due to the LAL.
  • Severe neurological disorders, not due to the LAL.
  • General State concerned (grades 3 and 4 WHO scale), not attributable to the LAL.

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 ClinicalTrials.gov identifier (NCT number): NCT02036489


Contacts
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Contact: Josep Mª Ribera, Dr jribera@iconcologia.net

Locations
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Spain
Hospital Germans Trias i Pujol Recruiting
Barcelona, Spain
Contact: Josep Mª Ribera, Dr       jribera@iconcologia.net   
Sponsors and Collaborators
PETHEMA Foundation

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Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT02036489     History of Changes
Other Study ID Numbers: LAL-RI/2008
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms
Prednisone
Vincristine
Daunorubicin
Asparaginase
Mercaptopurine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors