AzTrials
AzTrials

Leukemia, Myelocytic, AcutePhase 2NCT01716793

Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

A Phase 2 study testing Ara-C, Autologous transplantation and Allogeneic HLA-identical sibling transplantation in people with Leukemia, Myelocytic, Acute, run by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias at 19 sites 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

In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50 years, the Spanish CETLAM group showed a complete remission rate 75 % using the combination of daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in continuous infusion during 7 days) and etoposide… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Leukemia, Myelocytic, Acute
What is being tested?
Ara-C, Autologous transplantation and Allogeneic HLA-identical sibling transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
19 sitesSpain
Study dates
Sep 1998to Nov 2003
Phase
Phase 2
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with newly diagnosed AML, classified by FAB criteria
  • Age not superior to 60 years
  • Verbal informed consent for the chemotherapy and written for the mobilization and stem cell transplantation

Who cannot join

  • Patients treated previously for its AML with other chemotherapy different from hydroxyurea
  • Acute promyelocytic leukemia (M3)
  • Chronic myeloid leukemia in blastic crisis
  • Leukemias appearing after other myeloproliferative processes
  • Leukemias surviving after myelodysplastic syndromes with more than 6 months of evolution
  • Presence of other neoplastic disease in activity
Show all 11Show fewer
  • Secondary AML which had appeared after cured malignancies (for instance Hodgkin disease) and those who are still exposed to alkylant agents or radiation
  • Renal and hepatic abnormal function with creatinine values and/or bilirubin two times higher than the normal threshold, except when this alteration could be attributed to the leukemia
  • Patients with a fraction of ejection very low (inferior to 40%), symptomatic cardiac insufficiency or both
  • Patients with a grave concomitant neurological or psychiatric disease
  • Positivity of HIV (donor and/or receptor)

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Spain19 sites

  • Hospital A Coruña

    A Coruña, Coruña, 15006

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Centro Medico Teknon

    Barcelona, Barcelona, 08022

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Jordi Esteve

    Barcelona, Barcelona, 08036

  • Hopital Universitari de Girona Dr. Josep Trueta

    Girona, Girona, 17007

  • ICO Hospital Universitari de Bellvitge

    L'Hospitalet Del Llobregat, Barcelona, 08907

  • Hospital Universitari Arnau de Vilanova

    Lleida, Lleida, 25006

  • Hospital Universitario Virgen de la Victoria

    Málaga, Malaga, 29010

  • Hospital General Universitario de Murcia

    Murcia, Murcia, 30008

  • Hospital Universitari Son Espases

    Palma de Mallorca, Mallorca, 07198

  • Joan Bargay

    Palma de Mallorca, Mallorca, 07198

  • Hospital Universitari Joan XXIII

    Tarragona, Tarragona, 43007

  • Mutua de Terrassa

    Terrassa, Terrassa, 08225

  • Hospital Verge de la Cinta

    Tortosa, Tarragona, 43517

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 496010

  • Hospital Universitario Rio Hortega

    Valladolid, Valladolid, 41010

Other trials in Spain

About this study

Official title: Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.

In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50 years, the Spanish CETLAM group showed a complete remission rate 75 % using the combination of daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in continuous infusion during 7 days) and etoposide (100mg/m2 IV/day 3 days). If idarubicin (10 mg/m2, 3 days) was administered instead of daunorubicin, the complete remission (CR) rate in adults up to 60 years was 75%. To improve the proportion of CRs and to decrease relapse rate appearing in 50% of patients, the phase II AML-99 trial includes intermediate dose-cytarabine during induction and risk-adapted post remission treatment based on the improvement in prognostic characterization of AML and the implementation of novel transplantation techniques.

Read the detailed description

Induction chemotherapy: idarubicin (12mg/m2/day intravenous), intermediate-dose cytarabine (500mg/m2/12h, intravenous) and etoposide (100mg/m2/day, intravenous) in 3+7+3 schedule. This induction therapy is repeated if complete remission (CR) is not achieved after the first course of treatment.

Consolidation therapy: mitoxantrone (12mg/m2/day, intravenous, days 4, 5 and 6) and intermediate-dose cytarabine (500mg/m2/12h from day 1 to 6).

Risk-stratification according to cytogenetics, courses to CR and availability of an HLA-identical sibling:

  • Patients in the favorable cytogenetics group [t(8;21), inv(16) or t(16;16)] are treated with high-dose cytarabine (3g/m2/12h, intravenous, days 1, 3 and 5).
  • Patients in intermediate cytogenetics group (normal karyotype and a single course to achieve the CR) receive an autologous peripheral blood stem cell (PBSC) transplant, regardless of having an HLA-identical sibling.
  • The remaining patients are considered in the high-risk group and are treated with autologous or allogeneic PBSC transplantation depending on the availability of a sibling donor. In allotransplants, CD34+ cell selection of hematopoietic cells is performed.
Being tested
Ara-C, Autologous transplantation, Allogeneic HLA-identical sibling transplantation, CD34+ selection
Keywords
Primary AML, Risk-adapted treatment, Hematopoietic transplantation, CD34+ cell selection
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • Ara-CDrug

    • Intermediate dose during induction phase to remission.
    • High-dose during consolidation phase in patients with favorable cytogenetics.

  • Autologous transplantationOther

    • In patients with normal karyotype and one cycle of chemotherapy to achieve complete remission.
    • In patients with other cytogenetics without HLA-Identical sibling.

  • Allogeneic HLA-identical sibling transplantationOther

    • Patients without favorable or normal karyotype(and one course to CR).
    • Patients with normal karyotype who need two cycles of chemotherapy to achieve CR, and other cytogenetics.

  • CD34+ selectionOther

    In allotransplants, it is performed a CD34+ cell selection of peripheral blood stem cell transplantation.

Study groups in NCT01716793
Study groupRoleWhat they receive
Risk-adapted postremission treatmentOtherAra-C, autologous transplantation, Allogeneic HLA-identical sibling transplantation depending on risk factors (cytogenetics, courses to CR)and availability of an HLA-identical sibling, CD34+ selection.
Receives: Drug: Ara-C; Other: Autologous transplantation; Other: Allogeneic HLA-identical sibling transplantation; Other: CD34+ selection

What is being measured

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

  1. Complete remission rate.

    Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.

    Measured: 2 months.

  2. Disease free survival.

    Analyze the disease free survival (DFS)of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.

    Measured: 4 years.

Secondary outcomes (3)

  1. Evaluations of minimal residual disease (MRD) by flow cytometry during and after treatment.

    Study of the immunophenotypic characteristics of the leukemic population at diagnosis and evaluation of MRD during different treatment phases and follow-up.

    Measured: 4 years.

  2. Feasibility to mobilize and collect autologous PBSC after consolidation phase.

    Evaluation of mobilization failures.

    Measured: 6 months.

  3. Evaluations of the CD34+ cell selection procedure and allogeneic peripheral blood stem cell (PBSC)transplantation outcome.

    CD34+ cell selection from PBSC of HLA-identical siblings. Conditioning regimen. Infusion and post-transplant follow-up.

    Measured: 4 years.

Timeline

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

  1. First posted30 Oct 2012 (estimated)
  2. Study startSep 1998
  3. Primary completionSep 1998
  4. Study completionNov 2003

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01716793
Sponsor's protocol ID
AML-99
Status last verified
Oct 2012
First submitted
22 Oct 2012
Last updated
1 Nov 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ara-C, Autologous transplantation and Allogeneic HLA-identical sibling transplantation in people with Leukemia, Myelocytic, Acute, run by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias at 19 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 3 inclusion and 11 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 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Complete remission rate. (time frame: 2 months.). The study lists 2 primary outcomes in all. 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 NCT01716793.

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 1 Nov 2012.

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