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Treatment of High Risk Adult Acute Lymphoblastic Leukemia (LAL-AR/2003)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853008
First Posted: February 27, 2009
Last Update Posted: January 12, 2017
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.
Information provided by (Responsible Party):
PETHEMA Foundation
  Purpose
Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.

Condition Intervention Phase
Acute Lymphoblastic Leukemia Drug: Vincristine Drug: Daunorubicin Drug: Prednisone Drug: Mitoxantrone Drug: Cytosine Arabinoside Drug: Dexamethasone Drug: Methotrexate (MTX) Drug: Cytarabine Drug: ASP Drug: Mercaptopurine Drug: Teniposide Drug: Hydrocortisone Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients. [ Time Frame: 2 years ]

Estimated Enrollment: 100
Study Start Date: January 2003
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Vincristine
    Vincristine (VCR): 1.5 mg/m2 (max 2 mg) IV d 1, 8, 15, 22 in induction VCR 2 mg, IV, d 1,8 in consolidation (cycle 1, 2)
    Drug: Daunorubicin
    Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22
    Drug: Prednisone
    Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28
    Drug: Mitoxantrone
    Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation
    Drug: Cytosine Arabinoside
    ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction
    Drug: Dexamethasone
    Dexamethasone 20 mg/m2,IV, d 1-5,10 mg/m2,IV, d 6 and 5 mg/m2,IV, d 7 in Consolidation (3 cycles)
    Drug: Methotrexate (MTX)
    Methotrexate (MTX)3 g/m2,IV, d1 (24h)in consolidation, cycles 1 and 2 MTX (15 mg/m2/wk, IM)in maintenance MTX 15 mg, IT
    Drug: Cytarabine
    Cytarabine 2g/m2/12h, IV d5 in cycle 1 consolidation Cytarabine 2g/m2/12h, IV d 1,2 in cycle 3 consolidation Cytarabine 30 mg, intrathecal
    Drug: ASP
    ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)
    Drug: Mercaptopurine
    Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation
    Drug: Teniposide
    Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3
    Drug: Hydrocortisone
    Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal
Detailed Description:
HR ALL included one or more of the following baseline parameters: age 30-60 yr, WBC count >25x109/L and 11q23 or MLL rearrangements. Induction therapy included vincristine, prednisone and daunorubicin for 4 weeks. In pts with slow cytologic response to therapy (≥10% blasts in bone marrow assessed on d14) intensified induction with high dose ARA-C and mitoxantrone was administered. Early consolidation therapy included 3 cycles with rotating cytotoxic drugs including high-dose methotrexate, high-dose ARA-C and high-dose asparaginase. Pts. with slow cytologic response on d14 or MRD level >0.05% after consolidation were assigned to allogeneic SCT (related or unrelated) and those with standard cytologic response on d14 and MRD level <0.05% after consolidation received 3 additional cycles of delayed consolidation (identical to those of early consolidation) followed by maintenance therapy up to 2yr in CR.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk ALL adult patients (age> 15 years)no treated previously
  • High-risk ALL:
  • One or more of the following:

    • Age 30-60 yr.
    • WBC count >25x109/L
    • 11q23 or ALL1/AF4
  • Very high-risk ALL:
  • HR ALL and one or the following:

    • Slow cytologic response (>10% blasts in BM on d14 of induction therapy).
    • MRD>0.05% (by flow cytometry) at the end of consolidation

Exclusion Criteria:

  • L3 ALL or B mature(sIg +) or t(8;14), t(2;8), t(8;22).
  • ALL Ph (BCR/ABL) positive.
  • Bifenotipics ALL as EGIL criteria.
  • Indifferentiated ALL.
  • Patients with cardiac pathology
  • Patients with chronic liver disease in activity fase
  • Pulmonary disease
  • Renal insufficiency not due to ALL
  • Neurological disorders not due to ALL
  • PS (grades 3 and 4) not due to ALL.
  Contacts and Locations
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): NCT00853008


Locations
Spain
Hospital General
Alicante, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Clínica Teknon
Barcelona, Spain
Hospital Clínic i Provincial
Barcelona, Spain
Hospital de Sant Pau
Barcelona, Spain
Hospital Duran y Reynals
Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital General
Castellón, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Puerta del Mar
Cádiz, Spain
Hospital Josep Trueta
Girona, Spain
Hospital Universitario
Guadalajara, Spain
Hospital Juan Canalejo
La Coruña, Spain
Hospital Xeral
Lugo, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico Universitario
Madrid, Spain
Hospital de Fuenlabrada
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Morales Messeguer
Murcia, Spain
Hospital Carlos Haya
Málaga, Spain
Hospital Virgen de la Victoria
Málaga, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Son Llàtzer
Palma de Mallorca, Spain
Clínica Universitaria de Navarra
Pamplona, Spain
Hospital Parc Taulí
Sabadell, Spain
Hospital Clínico Universitario
Salamanca, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Xeral
Santiago, Spain
Hospital Virgen del Rocio
Sevilla, Spain
Hospital Joan XXIII
Tarragona, Spain
Hospital Mútua de Terrassa
Terrassa, Spain
Hospital Clínico Universitario
Valencia, Spain
Hospital Dr Pesset
Valencia, Spain
Hospital General
Valencia, Spain
Hospital La Fe
Valencia, Spain
Hospital Clínico
Valladolid, Spain
Hospital Virgen de la Concha
Zamora, Spain
Hospital Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Ribera Josep Mª, Dr PETHEMA Foundation
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00853008     History of Changes
Other Study ID Numbers: LAL-AR/2003
First Submitted: February 25, 2009
First Posted: February 27, 2009
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leukemia
High-Risk (HR)
Philadelphia Chromosome-Negative

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
Dexamethasone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Dexamethasone
Prednisone
Hydrocortisone
Methotrexate
Cytarabine
Vincristine
Mitoxantrone
Daunorubicin
6-Mercaptopurine
Teniposide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents


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