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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by PETHEMA Foundation
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00853008
First received: February 25, 2009
Last updated: October 27, 2014
Last verified: October 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2003
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
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: NCT00853008

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

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

Additional Information:
No publications provided by PETHEMA Foundation

Additional 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
Study First Received: February 25, 2009
Last Updated: October 27, 2014
Health Authority: Spain: Ministry of Health

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

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
6-Mercaptopurine
BB 1101
Cortisol succinate
Cytarabine
Daunorubicin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Methotrexate
Mitoxantrone
Prednisone
Teniposide
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Anti-Infective Agents

ClinicalTrials.gov processed this record on November 25, 2014