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AML Treatment in Untreated Adult Patients (LAM99P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00449319
Recruitment Status : Unknown
Verified November 2017 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was:  Recruiting
First Posted : March 20, 2007
Last Update Posted : November 17, 2017
Sponsor:
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:

The present therapy intends to be an homogeneous treatment for AML patients based on a pretreatment with hydroxiurea plus an induction therapy with the standard arm with Daunorubicine as according to EORTC-GIMEMA AML10 study.

The post-remissional treatment is based on transplant with HLA compatible donor is foreseen for all patients and autologous transplant for those without HLA compatible donor available.


Condition or disease Intervention/treatment Phase
Leukemia, Myelocytic, Acute Procedure: Identification of appropriate therapies according to risks factors Drug: Daunorubicine Procedure: Transplant Not Applicable

Detailed Description:

GIMEMA treatment for adult (15-60 yrs) AML patients included a 3-drug induction cycle with DNR (50 mg/m2 d 1, 3, 5), cytarabine (100 mg/m2 d1-10), etoposide (100 mg/m2 d1-5) followed by an intensive consolidation with cytarabine (500 mg/m2/q12 hrs d1-d6) and the same anthracycline as in induction on d 4-6. Following consolidation, eligible pts (age <45 or 55 yrs) with a HLA compatible sibling had to be allografted, the others, had to be autografted with autologous peripheral stem cell (PSC) collected during recovery from consolidation.

BM and PB samples at diagnosis were centralized according to a national GIMEMA original study planned with the aim to accurately evaluate biological characteristics at diagnosis and to identify genetic alterations with prognostic relevance and to follow up cases monitoring minimal disease during remission. To allow the adequate collection and sending of samples before starting intensive chemotherapy, all patients received a 5-day pretreatment consisting of hydroxiurea (HU) at the dosage of 2 g/m2/day, also effective for "debulkying" of disease.

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10
Actual Study Start Date : November 1998
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018






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Ages Eligible for Study:   15 Years to 61 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AML "de novo" with bone marrow blasts <=30%
  • Performance status: 0-3
  • FAB subtype: all except M3
  • Written informed consent

Exclusion Criteria:

  • age <15 years and >= 61 years
  • pretreated AML with chemiotherapy (except Idrossiurea) or radiotherapy or corticosteroids for more than 7 days.
  • diagnosis of acute promyelocitic leukemia (M3)
  • Performance status = 4
  • Uncontrolled infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449319


Contacts
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Contact: Marco VIGNETTI, Dr +39 06 441639831 m.vignetti@gimema.it
Contact: Paola FAZI, Dr. +39 06 441639830 p.fazi@gimema.it

Locations
Show Show 36 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Franco MANDELLI, Pr. Gruppo Italiano Malattie EMatologiche dell'Adulto
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ClinicalTrials.gov Identifier: NCT00449319    
Other Study ID Numbers: LAM99P
First Posted: March 20, 2007    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
AML
adult
Hydroxyurea
Transplant
Toevaluate biological characteristics at diagnosis.
To identify genetic alterations with prognostic relevance.
To follow up cases monitoring minimal disease during remission.
To evaluate pretreatment therapy in terms of response rate and toxicity.
Disease free survival.
Overal survival.
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Daunorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action