Randomised Prospective Comparison of the NMA Allograft and the Traditional Allograft in Acute Myeloid Leukaemia

December 13, 2005 updated by: Assistance Publique - Hôpitaux de Paris

Randomised Prospective Comparison of the nonmyélo-Ablative Allograft and the Traditional Allograft in Acute Myeloid Leukaemia in Complete Remission of the Adult

The allograft of marrow in its technique of reference (myélo-ablative (MA) condition by cyclophosphamide and total body irradiation (TBI) with strong amounts) therapeutic is recognized acute myeloid leukaemia (AML) of the adult for the patients of less than 55 years, because it offers chances of cure higher than chemotherapy or the auto-graft. However, mortality related to the traditional graft is approximately 30% to 1 year. The recent use of the non-myélo-ablative graft (NMA), in which the anti-leukaemia effect rests exclusively on the allogenic effect "graft-versus-leukaemia" makes it possible to obtain among patients of more than 55 years in complete reemission (CR), survivals without relapses comparable with the traditional allograft among patients of more than 35 years. The major interest of NMA graft is to reduce early mortality related to the graft. This reduction should be all the more significant as the patient is younger, and thus bring to a better survival. There is not, at the present hour, of prospective comparative study of the two procedures of graft. Taking into account the results observed after NMA graft among patients of more than 55 years, and taking into account the toxicity of the standard graft between 35 and 55 years, it is essential to now compare the 2 approaches among patients who do not have a counter-indication for one or the other, in the age bracket where the toxicity of the traditional graft is highest.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Will not be included in CR1 nor the patients with good forecast under chemotherapy, (Inv 16; t(8;21)), nor patients at the very high risk of relapse (anomalies complex cytogenetics). The conditioning of MA graft will be Cyclophosphamide and ICT with strong amounts. NMA graft will be made according to the protocol Seattle (fludarabine 30 mg/m2/j X 3 and ICT of 2 Gy). The study will be undertaken in 12 French centers of allograft taking part in the protocols ESPARTO or EORTC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Val de Marne
      • Créteil, Val de Marne, France, 94010
        • Recruiting
        • Henri Mondor Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: from 35 to 55 years completed
  2. de novo Acute Myeloid Leukaemia (AML) in Complete remission (CR)1, requiring an allograft according to the therapeutic protocol in which (or according to which) the patient is treated or secondary AML with a myelodysplasy or a chemotherapy in CR1 or de novo AML or secondary to a myelodysplasy or a chemotherapy, in CR2.
  3. having an géno-identical fraternal donor
  4. having received, since obtaining the remission (1 or 2) a consolidation comprising at least 6 bolus of Aracytine (> 500 mg/m2 for each amount) and at least 1 day of anthracycline to the usual amounts (Idarubicin: 12 mg/m2 or Daunorubicin 50 to 80 mg/m2)
  5. Signed assent of receiver
  6. Signed assent of the donor

Exclusion Criteria:

  1. If CR1: AML with T 8,21 or inv 16 or LAM3, or AML with complex anomalies cytogenetics (= 5 anomalies without relation between them)
  2. If CR2: duration of CR1 < 4 months
  3. Acute transformation of a myeloproliferative syndrome
  4. Former autograft or allogreffe
  5. Karnofsky < 50%
  6. Clearance of creatinin < 40 ml/min
  7. Transaminases > 8 N
  8. Any situation contra-indicating a traditional conditioning of allograft, in particular: serious cardiopathy, chronic respiratory insufficiency cutting down the pulmonary functions by at least 30%, fibrose hepatic.
  9. Donor having a counter-indication with the administration of growth promoters or a general anaesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
To show that NMA graft reduces mortality related to the procedure to 10%, compared to 30% waited in the arm of reference (α : 5%; p: 80%; bilateral formulation), 50 patients will be included in each arm

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
1- global survival, without relapse, and the various complications of the graft at 2 years 2- quality of life 3- the cost. 4- kinetics of the chimerism donor/receiver and his predictive value of the relapse and the reaction of the graft against the host.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: CORDONNIER Catherine, Professor, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2005

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P040420
  • AOM04088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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