- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00853008
Treatment of High Risk Adult Acute Lymphoblastic Leukemia (LAL-AR/2003)
April 6, 2020 updated by: PETHEMA Foundation
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alicante, Spain
- Hospital General
-
Badalona, Spain
- Hospital Germans Trias i Pujol
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Barcelona, Spain
- Hospital de Sant Pau
-
Barcelona, Spain
- Hospital Clinic I Provincial
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Barcelona, Spain
- Hospital Vall d'Hebron
-
Barcelona, Spain
- Clínica Teknon
-
Barcelona, Spain
- Hospital Duran y Reynals
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Castellón, Spain
- Hospital General
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Cáceres, Spain
- Hospital San Pedro de Alcántara
-
Cádiz, Spain
- Hospital Puerta Del Mar
-
Girona, Spain
- Hospital Josep Trueta
-
Guadalajara, Spain
- Hospital Universitario
-
La Coruña, Spain
- Hospital Juan Canalejo
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Lugo, Spain
- Hospital Xeral
-
Madrid, Spain
- Hospital Ramon y Cajal
-
Madrid, Spain
- Hospital 12 de Octubre
-
Madrid, Spain
- Hospital Clínico Universitario
-
Madrid, Spain
- Hospital De Fuenlabrada
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Murcia, Spain
- Hospital Morales Messeguer
-
Málaga, Spain
- Hospital Carlos Haya
-
Málaga, Spain
- Hospital Virgen de la Victoria
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Oviedo, Spain
- Hospital Central de Asturias
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Palma de Mallorca, Spain
- Hospital Son Llàtzer
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Pamplona, Spain
- Clinica Universitaria de Navarra
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Sabadell, Spain
- Hospital Parc Taulí
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Salamanca, Spain
- Hospital Clínico Universitario
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Santander, Spain
- Hospital Marques de Valdecilla
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Santiago, Spain
- Hospital Xeral
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Sevilla, Spain
- Hospital Virgen del Rocío
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Tarragona, Spain
- Hospital Joan XXIII
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Terrassa, Spain
- Hospital Mutua De Terrassa
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Valencia, Spain
- Hospital la Fe
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Valencia, Spain
- Hospital Clínico Universitario
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Valencia, Spain
- Hospital Dr Pesset
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Valencia, Spain
- Hospital General
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Valladolid, Spain
- Hospital Clínico
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Zamora, Spain
- Hospital Virgen de la Concha
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Zaragoza, Spain
- Hospital Lozano Blesa
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ribera Josep Mª, Dr, PETHEMA Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 25, 2009
First Submitted That Met QC Criteria
February 26, 2009
First Posted (Estimate)
February 27, 2009
Study Record Updates
Last Update Posted (Actual)
April 7, 2020
Last Update Submitted That Met QC Criteria
April 6, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Antibiotics, Antineoplastic
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Dexamethasone
- Prednisone
- Cytarabine
- Methotrexate
- Vincristine
- Daunorubicin
- Mitoxantrone
- Mercaptopurine
- Hydrocortisone
- Teniposide
Other Study ID Numbers
- LAL-AR/2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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