Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2003-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leukemia, Myelocytic, Acute

Keywords

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Primary AML Risk-adapted treatment Hematopoietic transplantation CD34+ cell selection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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Ara-C

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

Intervention Type DRUG

Autologous transplantation

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

Intervention Type OTHER

Allogeneic HLA-identical sibling transplantation

* 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.

Intervention Type OTHER

CD34+ selection

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorge Sierra, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Salut Brunet, MD

Role: STUDY_CHAIR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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Spain

Other Identifiers

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AML-99

Identifier Type: -

Identifier Source: org_study_id

Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Risk-adapted postremission treatment

Ara-C

Autologous transplantation

Allogeneic HLA-identical sibling transplantation

CD34+ selection

Interventions

Ara-C

Autologous transplantation

Allogeneic HLA-identical sibling transplantation

CD34+ selection

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

Responsible Party

Principal Investigators

Jorge Sierra, MD

Salut Brunet, MD

Locations

Hospital Germans Trias i Pujol

Hospital del Mar

Centro Medico Teknon

Hospital de la Santa Creu i Sant Pau

Hospital Vall d'Hebron

Jordi Esteve

ICO Hospital Universitari de Bellvitge

Hospital A Coruña

Hopital Universitari de Girona Dr. Josep Trueta

Hospital Universitari Arnau de Vilanova

Hospital Universitario Virgen de la Victoria

Hospital Universitari Son Espases

Joan Bargay

Hospital General Universitario de Murcia

Hospital Universitari Joan XXIII

Hospital Verge de la Cinta

Mutua de Terrassa

Hospital Clínico Universitario de Valencia

Hospital Universitario Rio Hortega

Countries

Other Identifiers

AML-99