AzTrials
AzTrials

Acute Lymphoblastic LeukemiaNCT01540812

Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS

An observational study of Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 1 site in Spain.

Completed

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

Official record
Search all trials

Trial summary

Trial protocol intended the optimization of induction treatment with: 1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation. 2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of high doses of anthracyclines has not brought higher response rates or longer… Read more about this study

Who is it for?
Ages 15 to 60 years
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
Vincristine in induction, Daunorubicin in induction and Prednisone in induction
How many people
418 participants
Where
1 siteSpain
Study dates
Feb 2012to 1 Dec 2019
Phase
Observational
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 15 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: ALL patients

Who may be able to join

  • ALL de novo high-risk criteria
  • Age 15-55 years (55-60 years patients will be included at the discretion of the medical team that will attend)
  • No prior treatment, except Emergency leukapheresis Emergency treatment of hyperleukocytosis with hydroxyurea Urgent cranial irradiation (one dose) for CNS leukostasis Mediastinal irradiation for urgent superior vena cava syndrome
  • General condition suitable scale (ECOG 0-2), or> 2 if due to ALL
  • Negative pregnancy test for women of childbearing age
  • Written informed consent because, although the protocol does not include the use of investigational drugs, biological samples sent there for them

Who cannot join

  • L3 type ALL or mature phenotype B (sIg +) or cytogenetic abnormalities characteristic of mature B-ALL (t (8; 14), t (2, 8), t (8; 22)). For these patients is available BURKIMAB protocol.
  • LAL Ph (BCR-ABL) positive. For these patients have the protocol ALL-Ph-08 (if under 55) or LALOPh (if over 55).
  • Lymphoid blast crisis of chronic myeloid leukemia
  • Biphenotypic acute leukemia or bilinear according to the criteria of EGIL group
  • Undifferentiated acute leukemias
  • Patients with a history of coronary artery disease, valvular or hypertensive heart disease, contraindicating the use of anthracyclines
Show all 14Show fewer
  • Patients with chronic phase of activity
  • Patients with severe chronic respiratory failure
  • Kidney failure due to ALL
  • Serious neurological disorder not due to the LAL
  • History of pancreatitis
  • Pregnancy or breastfeeding
  • Mental or psychiatric illness preventing informed consent is given for sending samples or properly follow the study
  • General condition affected, not attributable to the ALL

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona

Other trials in Spain

About this study

Trial protocol intended the optimization of induction treatment with:

  1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation.
  2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of high doses of anthracyclines has not brought higher response rates or longer duration
  3. Replacing the poor cytological response at day 14 by the level of ER at the end of induction as a criterion to decide the further treatment (consolidation or second induction), so as to have only one criterion (the ER) throughout the study to decision making.
Read more

For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2) in patients with ALL-T, since there is recent evidence of a higher response rate with this strategy.

Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate level of ER after two cycles of induction or in those patients who required two courses of induction and have obtained proper ER after the second.

Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards, to avoid bias in making treatment decisions

Being tested
Vincristine in induction, Daunorubicin in induction, Prednisone in induction, Metotrexato in induction, Cytarabine in induction
Keywords
Acute Lymphoblastic Leukemia
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.

  • Vincristine in inductionDrug

  • Daunorubicin in inductionDrug

  • Prednisone in inductionDrug

  • Metotrexato in inductionDrug

  • Cytarabine in inductionDrug

  • Hydrocortisone in inductionDrug

  • Idarubicin in induction-2Drug

  • Fludarabine in induction-2Drug

  • Ara-C in induction-2Drug

  • G-CSF in induction-2Drug

  • Dexamethasone in consolidation-1Drug

  • Vincristrine in consolidation-1Drug

  • Metotrexato in consolidation-1Drug

  • PEG-ASP in consolidation-1Drug

  • Dexamethasone in consolidation-2Drug

  • ARA-C in consolidation-2Drug

  • PEG-ASP in consolidation-2Drug

  • Dexamethasone in consolidation-3Drug

  • Vincristine in consolidation-3Drug

  • Metotrexato in consolidation-3Drug

  • PEG-ASP in consolidation-3Drug

  • allogeneic HSCTProcedure or surgery

  • Allo HSCT with reduced-intensity conditioningProcedure or surgery

Study groups in NCT01540812
Study groupRoleWhat they receive
V + Dauno+ Pred+ Metot+ Cyta+ Hc + Ida + FludVincristine in induction:5 mg/m2 i.v. days 1, 8, 15 and 22 in induction phase Daunorubicin in induction 45 mg/m2 i.v. days 1, 8, 15 and 22 Prednisone in induction: 60 mg/m2/ day, i.v. o p.o., days 1 to 14; 30 mg/m2/day, i.v. o p.o., days 15 to 21; 15 mg/m2/day i.v. o p.o., days 21 to 28 Metotrexato 12 mg days 1 and 22 (intrathecal) Cytarabine (ARA-C): 30 mg days 1 and 22 (intrathecal) Hydrocortisone: 20 mg days 1 and 22 (intrathecal) Idarubicin-induction 2 12 mg/m2, i.v., days 1, 3 and 5 Fludarabine in induction-2: Fludarabine 30 mg/m2, i.v., days, 1 to 5
Receives: Drug: Vincristine in induction; Drug: Daunorubicin in induction; Drug: Prednisone in induction; Drug: Metotrexato in induction; Drug: Cytarabine in induction; Drug: Hydrocortisone in induction; Drug: Idarubicin in induction-2; Drug: Fludarabine in induction-2; Drug: Ara-C in induction-2; Drug: G-CSF in induction-2; Drug: Dexamethasone in consolidation-1; Drug: Vincristrine in consolidation-1; Drug: Metotrexato in consolidation-1; Drug: PEG-ASP in consolidation-1; Drug: Dexamethasone in consolidation-2; Drug: ARA-C in consolidation-2; Drug: PEG-ASP in consolidation-2; Drug: Dexamethasone in consolidation-3; Drug: Vincristine in consolidation-3; Drug: Metotrexato in consolidation-3; Drug: PEG-ASP in consolidation-3; Procedure: allogeneic HSCT; Procedure: Allo HSCT with reduced-intensity conditioning

What is being measured

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

  1. Overall response rate

    Improve the results of the protocol ALL-AR-03 with modifications in the study methodology of residual disease: centralized, Biomed protocols and the cut-off - <0.01% - internationally accepted and changes in the induction and consolidation treatment, without altering the overall design

    Measured: 2 years

Secondary outcomes (5)

  1. Evaluate CR rate with addition of PEG-ASP in the induction phase

    Measured: 2 years

  2. Standarization of minimal residual disease

    Determination of minimal residual disease in a central laboratory trying to homogenice the results

    Measured: 2 years

  3. To assess the toxic mortality

    To assess whether the reduction of daunorubicin in induction and changes in the consolidation drugs reduce toxic mortality in patients in complete remission

    Measured: 2 years

  4. Assess the proportion of non-responders or slow responders

    Measured: 2 years

  5. Overall survival

    Measured: 5 years

Timeline

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

  1. First posted29 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completion20 Nov 2019
  4. Study completion1 Dec 2019

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01540812
Sponsor's protocol ID
LAL-AR/2011
Status last verified
Mar 2020
First submitted
23 Feb 2012
Last updated
9 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Ribera JM, Morgades M, Ciudad J, Montesinos P, Esteve J, Genesca E, Barba P, Ribera J, Garcia-Cadenas I, Moreno MJ, Martinez-Carballeira D, Torrent A, Martinez-Sanchez P, Monsalvo S, Gil C, Tormo M, Artola MT, Cervera M, Gonzalez-Campos J, Rodriguez C, Bermudez A, Novo A, Soria B, Coll R, Amigo ML, Lopez-Martinez A, Fernandez-Martin R, Serrano J, Mercadal S, Cladera A, Gimenez-Conca A, Penarrubia MJ, Abella E, Vall-Llovera F, Hernandez-Rivas JM, Garcia-Guinon A, Bergua JM, de Rueda B, Sanchez-Sanchez MJ, Serrano A, Calbacho M, Alonso N, Mendez-Sanchez JA, Garcia-Boyero R, Olivares M, Barrena S, Zamora L, Granada I, Lhermitte L, Feliu E, Orfao A. Chemotherapy or allogeneic transplantation in high-risk Philadelphia chromosome-negative adult lymphoblastic leukemia. Blood. 2021 Apr 8;137(14):1879-1894. doi: 10.1182/blood.2020007311.

    PubMed 33150388

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 1 site 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 6 inclusion and 14 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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?

Overall response rate (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 NCT01540812, 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 9 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in