Myeloid LeukemiaGREFFENCT03659084
Study of the Outcome of Patients With Acute Myeloblastic Leukemia and Myelodysplastic Syndrome Receiving Iron Chelation Therapy After Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of Myeloid Leukemia and Myelodysplastic Syndromes, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Iron chelation, mostly associated with multiple red blood cell transfusion, is relatively common in patients with hematological malignancies receiving allo-HSCT. This multicenter prospective observational study is designed to establish the impact of iron chelation on relapse after allo-HSCT in patients with acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- EXJADE
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Apr 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute leukemia (AML) or Myelodysplastic Syndrome (MDS) and iron overload with ferritinemia ≥ 1000 μg / l, 6 months after CSH allograft.
Who may be able to join
- adults older than 18 years old
- Patients with AML or MDS in complete remission receiving CSH transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning.
- Patients with iron overload defined by at least one ferritinemia> 1000 μg / L in the 6th month after CSH allograft
- Creatinine less than 1.5 x ULN; ALAT and ASAT <2 x ULN
- Patients giving their informed consent (prior to performing any study procedure)
Who cannot join
- Hypersensitivity to the Exjade
- Association with another iron chelator
- Proteinuria> 1g / 24h
- Acute and chronic hepatitis (B and C viruses); HIV
- Extended corrected QT
- History of ocular toxicity related to iron chelation treatment
- Gastrointestinal Abnormal Absorption of Oral Medications
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite
Mauricette Michallet, MD, 0 478 86 22 20 ext. +33, mauricette.michallet@lyon.unicancer.fr
Mohamed ELHAMRI, PhD, 0478 86 22 20 ext. +33, mohamed.el-hamri@chu-lyon.fr
About this study
Official title: Multicenter Prospective Observational Study of the Outcome of Patients With Acute Myeloblastic Leukemia (AML) and Myelodysplastic Syndrome (MDS) Receiving Iron Chelation Therapy (Exjade) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
Iron chelation, mostly associated with multiple red blood cell transfusion, is relatively common in patients with hematological malignancies receiving allo-HSCT.
This multicenter prospective observational study is designed to establish the impact of iron chelation on relapse after allo-HSCT in patients with acute myeloid leukemia and myelodysplastic syndrome. The investigators will compare the results obtained in the prospective study to those observed in a historical retrospective cohort of paired patients who did not receive chelation. Given our clinical experience and literature results, the investigators will evaluate the Exjade chelator. Although not demonstrated, the presence of mutations of the HFE gene could play an indirect role on leukemogenesis by promoting overload. It is therefore important to evaluate the status in this patient population.
- Conditions
- Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- EXJADE
- Keywords
- Acute myeloid leukaemia, Myelodysplastic syndrome, Iron Chelation Therapy (Exjade), allogeneic Hematopoietic Stem Cell transplantation (Allo-HSCT)
- Medical subject headings
- Leukemia, Myeloid, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXJADEDrug
The patient having given his consent, will begin the Exjade at 10 mg / kg per day if the ferritin level reached 1000 ng / ml at 6 months after allograft, for a minimum duration of three months and up to 6 months. The iron parameters will be evaluated at 3, 6, 9, 12, 18 and 24 months after the beginning of the exjade treatment. The evaluation of the disease will be carried out according to the practices of the center. It is recommended to have a washout period of one week between stopping the ciclosporin and the beginning of treatment by exjade.
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of iron chelation on relapse-free survival rate
Relapse-free survival will be defined as the number of days between the date of diagnosis and the date of death and / or relapse (or censored at the end of follow-up).
Measured: At 2 years
Secondary outcomes (6)
Comparison of relapse-free survival after allograft of chelated patients to allografted patients not receiving chelation.
Matching variables will include disease type (AML or MDS), prognostic factors (cytogenetics, molecular biology, age), donor type / matching, and type of conditioning.
Measured: At 2-year
Cumulative incidence of GVHD
Acute and chronic GVHD date and maximum grade using international classification
Measured: 3 months, 1 and 2 years
Rate of infection
during the observation period
Measured: Through study completion, an average of 4 years
Hematological toxicity during administration of Exjade
Hemoglobin level; Current average frequency of transfusions
Measured: Through study completion, an average of 4 years
Non-hematological toxicity during administration of Exjade
Ferritinemia
Measured: Through study completion, an average of 4 years
Non-hematological toxicity during administration of Exjade
Transferrin
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startApr 2016
- Primary completionApr 2018
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauricette MICHALLET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659084
- Sponsor's protocol ID
- 2013.812
- Acronym
- GREFFE
- Status last verified
- Sep 2018
- First submitted
- 27 Aug 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Observational Study of the Outcome of Patients With Acute Myeloblastic Leukemia (AML) and Myelodysplastic Syndrome (MDS) Receiving Iron Chelation Therapy (Exjade) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
- ClinicalTrials.gov ID
- NCT03659084
- Acronym / sponsor ID
- GREFFE / 2013.812
- Conditions
- Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- Acute myeloid leukaemia, Myelodysplastic syndrome, Iron Chelation Therapy (Exjade), allogeneic Hematopoietic Stem Cell transplantation (Allo-HSCT)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2020 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iron chelation, mostly associated with multiple red blood cell transfusion, is relatively common in patients with hematological malignancies receiving allo-HSCT.
This multicenter prospective observational study is designed to establish the impact of iron chelation on relapse after allo-HSCT in patients with acute myeloid leukemia and myelodysplastic syndrome. The investigators will compare the results obtained in the prospective study to those observed in a historical retrospective cohort of paired patients who did not receive chelation. Given our clinical experience and literature results, the investigators will evaluate the Exjade chelator. Although not demonstrated, the presence of mutations of the HFE gene could play an indirect role on leukemogenesis by promoting overload. It is therefore important to evaluate the status in this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute leukemia (AML) or Myelodysplastic Syndrome (MDS) and iron overload with ferritinemia ≥ 1000 μg / l, 6 months after CSH allograft.
Key inclusion criteria (5 listed)
- adults older than 18 years old
- Patients with AML or MDS in complete remission receiving CSH transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning.
- Patients with iron overload defined by at least one ferritinemia> 1000 μg / L in the 6th month after CSH allograft
- Creatinine less than 1.5 x ULN; ALAT and ASAT <2 x ULN
- Patients giving their informed consent (prior to performing any study procedure)
Key exclusion criteria (8 listed)
- Hypersensitivity to the Exjade
- Association with another iron chelator
- Proteinuria> 1g / 24h
- Acute and chronic hepatitis (B and C viruses); HIV
- Extended corrected QT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXJADEThe patient having given his consent, will begin the Exjade at 10 mg / kg per day if the ferritin level reached 1000 ng / ml at 6 months after allograft, for a minimum duration of three months and up to 6 months. The iron parameters will be evaluated at 3, 6, 9, 12, 18 and 24 months after the beginning of the exjade treatment. The evaluation of the disease will be carried out according to the practices of the center. It is recommended to have a washout period of one week between stopping the ciclosporin and the beginning of treatment by exjade. | Drug | – |
Primary outcome
Impact of iron chelation on relapse-free survival rate
Time frame: At 2 years
Relapse-free survival will be defined as the number of days between the date of diagnosis and the date of death and / or relapse (or censored at the end of follow-up).
6 secondary outcomes
Comparison of relapse-free survival after allograft of chelated patients to allografted patients not receiving chelation.
Time frame: At 2-year
Cumulative incidence of GVHD
Time frame: 3 months, 1 and 2 years
Rate of infection
Time frame: Through study completion, an average of 4 years
Hematological toxicity during administration of Exjade
Time frame: Through study completion, an average of 4 years
Non-hematological toxicity during administration of Exjade
Time frame: Through study completion, an average of 4 years
Non-hematological toxicity during administration of Exjade
Time frame: Through study completion, an average of 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricette MICHALLET, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloid Leukemia and Myelodysplastic Syndromes, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Sep 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauricette MICHALLET, MD, PhD (33(0)478862220, mauricette.michallet@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of iron chelation on relapse-free survival rate (time frame: At 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2018.