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AzTrials

Acute Lymphoblastic LeukemiaPhase 4LAL-AR/2003NCT00853008

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

A Phase 4 study testing Vincristine, Daunorubicin and Prednisone in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 38 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
Vincristine, Daunorubicin and Prednisone
Type of treatment
Injection or infusion
How many people
100 participants
Where
38 sitesSpain
Study dates
Jan 2003to Dec 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Pulmonary disease
  • Renal insufficiency not due to ALL
  • Neurological disorders not due to ALL
  • PS (grades 3 and 4) not due to ALL.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

Spain38 sites

  • Hospital Juan Canalejo

    A Coruña

  • Hospital General

    Alicante

  • Hospital Germans Trias i Pujol

    Badalona

  • Clínica Teknon

    Barcelona

  • Hospital Clínic i Provincial

    Barcelona

  • Hospital de Sant Pau

    Barcelona

  • Hospital Duran y Reynals

    Barcelona

  • Hospital Vall d'Hebrón

    Barcelona

  • Hospital San Pedro de Alcántara

    Cáceres

  • Hospital Puerta del Mar

    Cadiz

  • Hospital General

    Castellon

  • Hospital Josep Trueta

    Girona

  • Hospital Universitario

    Guadalajara

  • Hospital Xeral

    Lugo

  • Hospital 12 de Octubre

    Madrid

  • Hospital Clínico Universitario

    Madrid

  • Hospital de Fuenlabrada

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Carlos Haya

    Málaga

  • Hospital Virgen de la Victoria

    Málaga

  • Hospital Morales Messeguer

    Murcia

  • Hospital Central de Asturias

    Oviedo

  • Hospital Son Llàtzer

    Palma de Mallorca

  • Clínica Universitaria de Navarra

    Pamplona

  • Hospital Parc Taulí

    Sabadell

  • Hospital Clínico Universitario

    Salamanca

  • Hospital Marqués de Valdecilla

    Santander

  • Hospital Xeral

    Santiago

  • Hospital Virgen del Rocio

    Seville

  • Hospital Joan XXIII

    Tarragona

  • Hospital Mútua de Terrassa

    Terrassa

  • Hospital Clínico Universitario

    Valencia

  • Hospital Dr Pesset

    Valencia

  • Hospital General

    Valencia

  • Hospital La Fe

    Valencia

  • Hospital Clínico

    Valladolid

  • Hospital Virgen de la Concha

    Zamora

  • Hospital Lozano Blesa

    Zaragoza

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Vincristine, Daunorubicin, Prednisone, Mitoxantrone, Cytosine Arabinoside
Keywords
Acute Lymphoblastic Leukemia, High-Risk (HR), Philadelphia Chromosome-Negative
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VincristineDrug

    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)

  • DaunorubicinDrug

    Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22

  • PrednisoneDrug

    Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28

  • MitoxantroneDrug

    Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation

  • Cytosine ArabinosideDrug

    ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction

  • DexamethasoneDrug

    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)

  • Methotrexate (MTX)Drug

    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

  • CytarabineDrug

    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

  • ASPDrug

    ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)

  • MercaptopurineDrug

    Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation

  • TeniposideDrug

    Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3

  • HydrocortisoneDrug

    Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2009 (estimated)
  2. Study startJan 2003
  3. Primary completionNov 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00853008
Sponsor's protocol ID
LAL-AR/2003
Acronym
LAL-AR/2003
Status last verified
Apr 2020
First submitted
25 Feb 2009
Last updated
7 Apr 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Ribera JM, Oriol A, Morgades M, Montesinos P, Sarra J, Gonzalez-Campos J, Brunet S, Tormo M, Fernandez-Abellan P, Guardia R, Bernal MT, Esteve J, Barba P, Moreno MJ, Bermudez A, Cladera A, Escoda L, Garcia-Boyero R, Del Potro E, Bergua J, Amigo ML, Grande C, Rabunal MJ, Hernandez-Rivas JM, Feliu E. Treatment of high-risk Philadelphia chromosome-negative acute lymphoblastic leukemia in adolescents and adults according to early cytologic response and minimal residual disease after consolidation assessed by flow cytometry: final results of the PETHEMA ALL-AR-03 trial. J Clin Oncol. 2014 May 20;32(15):1595-604. doi: 10.1200/JCO.2013.52.2425. Epub 2014 Apr 21.

    PubMed 24752047

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vincristine, Daunorubicin and Prednisone in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 38 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00853008, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.

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