Relapsed or Refractory Acute Myeloid LeukemiaPhase 3DEXAML-03NCT03765541
Dexamethasone in Refractory or First Relapsed Acute Myeloid Leukemia
A Phase 3 study testing Dexamethasone, Amsacrine and Cytarabine in people with Relapsed or Refractory Acute Myeloid Leukemia, run by University Hospital, Toulouse at 10 sites in France.
Trial summary
Recent preclinical and retrospective clinical data have suggested that dexamethasone might sensitize leukemic cells to chemotherapy-induced cell death and thus limit the risk of leukemic regrowth and relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Acute Myeloid Leukemia
- What is being tested?
- Dexamethasone, Amsacrine and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 10 sitesFrance
- Study dates
- 13 Jan 2020to 31 May 2024
- Phase
- Phase 3
- 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
Who may be able to join
- At least 18 years of age or older
- Diagnosis of acute myeloid leukemia by World Health Organization classification
- First relapsed or refractory acute myeloid leukemia with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, and meeting the following criteria:
- First relapsed acute myeloid leukemia :
- First relapse occurred at least 90 days to 24 months after the first complete remission or complete remission with incomplete recovery
- The first complete remission or complete remission with incomplete recovery had to result from no more than 2 cycles of cytotoxic chemotherapy. At least 1 induction cycle must have consisted of an anthracycline and cytarabine combination with a reasonable schedule/dose of anthracycline in the judgment of the investigator.
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- The re-emergence of at least 5% leukemic blasts in bone marrow is not attributable to other causes, regardless of new or recurrent dysplastic changes or extramedullary disease, or the re-emergence of at least 1% blasts in the peripheral blood is not attributable to other causes such as regenerating marrow.
- Refractory acute myeloid leukemia :
- Persistent acute myeloid leukemia was documented by bone marrow biopsy or aspirate at least 28 days after day 1 of the first induction cycle of 1 or 2 cycles of cytotoxic chemotherapy.
- Re-emergence of at least 5% leukemic blasts in bone marrow or at least 1% blasts in peripheral blood is not attributable to other causes such as regenerating marrow, and was less than 90 days after the first complete remission or complete remission with incomplete recovery.
- Prior induction therapy had to include no more than 2 cycles of cytotoxic chemotherapy. At least 1 induction cycle must have consisted of an anthracycline and cytarabine combination with a reasonable schedule/dose of anthracycline in the judgment of the investigator.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Left ventricular ejection fraction ≥ 50% by echocardiogram or multi-gated acquisition scan ; only applicable for patients who will receive intensive chemotherapy.
- Serum creatinine ≤ 150 µmol/L and/or total bilirubin ≤ 1.5 × the upper limit of normal and/or, aspartate aminotransferase ≤ 2.5 × the upper limit of normal, and/or alanine aminotransferase ≤ 2.5 × the upper limit of normal (unless related to acute myeloid leukemia)
- Any clinically significant non-hematological toxicity after prior chemotherapy must be resolved or of grade 1 as per Common Terminology Criteria for Adverse Events version 4.03.
- Women must be surgically or biologically sterile, or in post-menopause (amenorrheic for at least 12 months), or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days prior to the randomization and agree to use a highly effective method of contraception throughout the entire duration of the study treatment (including dose interruptions) and until 3 months after the last study treatment administration. Men must be surgically or biologically sterile, or agree to use a highly effective method of contraception throughout the entire duration of the study treatment (including dose interruptions) and until 6 months after the last study treatment administration.
- Registered to, or beneficiary of, social security insurance or equivalent.
- Signed written informed consent by both the patient and the investigator prior to perform any study-relayed procedure not part of normal medical care.
Who cannot join
- Acute promyelocytic leukemia (M3 subtype of acute myeloid leukemia).
- More than 2 cycles of first line induction chemotherapy.
- Acute myeloid leukemia with Philadelphia chromosome or BCR-ABL1 or blast crisis stage of chronic myeloid leukemia.
- Known or suspected central nervous system leukemia.
- Undergoing allogeneic hematopoietic stem cell transplantation within 90 days prior to randomization, or being on immunosuppressive therapy for prophylaxis of graft-versus-host disease, or experiencing graft-versus-host disease within 2 weeks prior to randomization.
- Use of any experimental, cytotoxic, or targeted, anti-leukemic therapy within 14 days prior to randomization, with the exception of hydroxyurea.
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- Formal contraindication to glucocorticoids.
- Non-acute myeloid leukemia-associated organic or psychiatric severe disease that contraindicates use of study treatment.
- Patient who may not be followed regularly in consultation because of psychological, family, social, or geographical reasons.
- History of uncontrolled other malignancy for at least two years, with the exception of basal cell carcinoma and in situ cervix carcinoma.
- Severe uncontrolled infection at time of inclusion.
- Positive serology for human immunodeficiency virus-1 or 2, and/or Human T-Cell lymphotropic viruses-1 or 2, and/or active viral infection with hepatitis B virus and/or hepatitis C virus.
- Pregnant (beta gonadotropic chorionic hormon positive) or breastfeeding woman.
- Incapable patient of age, under guardianship, under curators or safeguard of justice.
- Patient under State Medical Assistance.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CH de la Côte Basque
Bayonne, France, 64100
CHU de Grenoble
Grenoble
CHU de Limoges
Limoges
Institut Paoli Calmettes
Marseille
CHU de Montpellier
Montpellier
CHU de Nantes
Nantes
CHU de Nîmes
Nîmes
CHU de Bordeaux
Pessac
CHU de Poitiers
Poitiers
CHU de la Réunion
Saint-Pierre, France, 97448
About this study
Official title: Dexamethasone Plus Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Patients With First Relapsed or Refractory Acute Myeloid Leukemia: a Randomized, Controlled, Open-label, Multicenter, Phase III Study
Recent preclinical and retrospective clinical data have suggested that dexamethasone might sensitize leukemic cells to chemotherapy-induced cell death and thus limit the risk of leukemic regrowth and relapse. Moreover, it has been experimentally shown that leukemic cells in acute myeloid leukemia patients who relapse become sensitive to glucocorticoids treatment highlighting a novel potential role for dexamethasone in relapsed or refractory acute myeloid leukemia (R/R).
This study was designed to determine whether adding dexamethasone to standard salvage therapy in the treatment of relapsed/refractory acute myeloid leukemia in adult patients (intensive chemotherapy amsacrine-cytarabine or azacitidine according to investigator's willingness) results in a significant improvement of the overall survival.
Read the detailed description
The prognosis for patients with relapsed or refractory acute myeloid leukemia is poor ; median survival is less than 1 year. High-dose cytarabine monotherapy or cytarabine-based combination regimens are often used as salvage therapy with limited efficacy. A recent retrospective study has shown that the addition of dexamethasone to intensive chemotherapy was significantly associated with better disease-free and overall survival in hyperleukocytic acute myeloid leukemia patients. The gene signatures of some molecular subgroups of acute myeloid leukemia were highly enriched in genes responsive to dexamethasone, including acute myeloid leukemia with NPM1 mutations which were particularly sensitive to the antileukemic activity of dexamethasone both in vitro and in vivo. Moreover, three recent preclinical studies have shown that cytarabine-resistant or RUNX1-mutated acute myeloid leukemia cells acquired sensitivity to glucocorticoids. Therefore, dexamethasone might sensitize leukemic stem cells to chemotherapy-induced cell death and thus limit the risk of relapse.
This study consists of a screening period, a treatment period, and a post-treatment follow-up period. Adult patients with relapsed/refractory acute myeloid leukemia are randomly assigned in a 1:1 ratio to receive either standard salvage therapy in combination with dexamethasone or standard salvage therapy alone. Standard salvage therapy is intensive chemotherapy (amsacrine-cytarabine) or azacitidine according to the investigator's willingness. For those patients with intensive chemotherapy amsacrine-cytarabine, the study treatment period includes 1 induction cycle and up to 3 consolidation cycles. For those patients with azacitidine, the study treatment period includes 3 cycles prior to the evaluation of the complete remission and thereafter lasts until progression. Of note, any patients in the study can undergo allogeneic hematopoietic stem cell transplantation providing his/her disease is controlled. After discontinuing the study treatment all patients must further carry out post-treatment follow-up visits every 3 months during the first and second year, and every 6 months thereafter until death, withdrawal of consent, loss to follow-up, or the end of the study, whichever occurs first. The end of the study is planned 5 years after the randomization of the first patient. The primary endpoint is the overall survival.
- Being tested
- Dexamethasone, Amsacrine, Cytarabine, Azacitidine
- Keywords
- dexamethasone, acute myeloid leukemia, relapse, refractory, azacitidine, amsacrine, cytarabine, randomized controlled trial
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
In combination with intensive chemotherapy amsacrine-cytarabine:
- Induction (1 cycle): 10 mg/12h from Day 1 to Day 3 of cycle (2 infusions/24h, slow IV [10 minutes])
- Consolidation (3 cycles): 10 mg/12h from Day 1 to Day 3 of each cycle (2 infusions/24h, slow IV [10 minutes])
In combination with azacitidine:
- Cycle 1: 20 mg/24h from Day 1 to Day 3 of cycle (1 infusion/24h, slow IV [10 minutes]).
- Subsequent cycles: 20 mg/24h on Day 1 of each cycle (1 infusion/24h, slow IV [10minutes]).
AmsacrineDrug
- Induction (1 cycle): 200 mg/m2/24h from Day 1 to Day 3 of cycle (slow IV [3 hours])
- Consolidation (3 cycles): 200 mg/m2/24h on Day 1 of each cycle (slow IV [3 hours])
CytarabineDrug
Patients < 60 years of age:
- Induction (1 cycle): 3 g/m2/12h from Day 1 to Day 4 of cycle (2 infusions/24h, slow IV [2 hours])
- Consolidation (3 cycles): 3 g/m2/12h from Day 1 to Day 3 of each cycle (2 infusions/24h, slow IV [2 hours]) Note: If the investigators believe that there is an undue risk for the safety of a patient under 60 years of age with comorbidity in receiving a dose level of 3 g/m2/12h, the dose may be reduced to 1 g/m2/12h
AzacitidineDrug
75 mg/m2/24h from Day 1 to Day 7 of each cycle [or from Day 1 to Day 5 and from Day 8 to Day 9 of each cycle] (SC)
| Study group | Role | What they receive |
|---|---|---|
| Standard salvage therapy + dexamethasone | Experimental | Intensive chemotherapy amsacrine-cytarabine or azacitidine according to the investigator's willingness in combination with dexamethasone Receives: Drug: Dexamethasone; Drug: Amsacrine; Drug: Cytarabine; Drug: Azacitidine |
| Standard salvage therapy alone | Active comparator | Intensive chemotherapy amsacrine-cytarabine or azacitidine according to the investigator's willingness Receives: Drug: Amsacrine; Drug: Cytarabine; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from the date of randomization to the date of death from any cause
Measured: Up to 60 months
Secondary outcomes (8)
Response to therapy
Best response of complete remission or complete remission with incomplete recovery as assessed by the investigators according to the 2010 European Leukemia Net recommendations for diagnosis and management of acute myeloid leukemia in adults
Measured: Up to 60 months
Minimal residual disease positivity
Quantitative assessment by either quantitative polymerase chain reaction or multiparameter flow cytometry of any tumor cells greater than pre-specified sensitivity thresholds of detection
Measured: Up to 60 months
Number of patient who realize allogeneic hematopoietic stem cell transplantation
Undergoing allogeneic hematopoietic stem cell transplantation
Measured: Up to 60 months
Duration of remission
Time from the date of first complete remission or complete remission with incomplete recovery to the date of relapse, where complete remission, complete remission with incomplete recovery, and relapse as assessed by the investigators according to the 2010 European Leukemia Net recommendations for diagnosis and management of acute myeloid leukemia in adults
Measured: Up to 60 months
Relapse-free survival
Time from the date of first complete remission or complete remission with incomplete recovery to the date of relapse or death from any cause, whichever occurs first, where complete remission, complete remission with incomplete recovery, and relapse as assessed by the investigators according to the 2010 European Leukemia Net recommendations for diagnosis and management of acute myeloid leukemia in adults
Measured: Up to 60 months
Event-free survival
Time from the date of randomization to the date of treatment failure, or relapse from complete remission or complete remission with incomplete recovery, or death from any cause, whichever occurs first, where treatment failure, complete remission, complete remission with incomplete recovery, and relapse as assessed by the investigators according to the 2010 European Leukemia Net recommendations for diagnosis and management of acute myeloid leukemia in adults
Measured: Up to 60 months
Quality of life with leukemia questionnaire
Scoring of functional assessment of cancer therapy - Leukemia questionnaire
Measured: At baseline, through complete remission, on Day 1 before dosing of each post-remission cycle, at 60 months
Adverse events
Adverse events reported according to the descriptions and grading scale found in the version 4.03 of the National Cancer Institute - Common Terminology Criteria for Adverse Events
Measured: During 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start13 Jan 2020
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Despite a recruitment target that was not met, we managed to achieve more than 50% of inclusions and 33% of deaths, enabling us to carry out an initial analysis of the primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian RECHER, PhD, Study director, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765541
- Sponsor's protocol ID
- RC31/17/0450
- Acronym
- DEXAML-03
- Status last verified
- Apr 2025
- First submitted
- 19 Nov 2018
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Plus Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Patients With First Relapsed or Refractory Acute Myeloid Leukemia: a Randomized, Controlled, Open-label, Multicenter, Phase III Study
- ClinicalTrials.gov ID
- NCT03765541
- Acronym / sponsor ID
- DEXAML-03 / RC31/17/0450
- Keywords
- dexamethasone, acute myeloid leukemia, relapse, refractory, azacitidine, amsacrine, cytarabine, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite a recruitment target that was not met, we managed to achieve more than 50% of inclusions and 33% of deaths, enabling us to carry out an initial analysis of the primary endpoint
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 5 Dec 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.
Recent preclinical and retrospective clinical data have suggested that dexamethasone might sensitize leukemic cells to chemotherapy-induced cell death and thus limit the risk of leukemic regrowth and relapse. Moreover, it has been experimentally shown that leukemic cells in acute myeloid leukemia patients who relapse become sensitive to glucocorticoids treatment highlighting a novel potential role for dexamethasone in relapsed or refractory acute myeloid leukemia (R/R).
This study was designed to determine whether adding dexamethasone to standard salvage therapy in the treatment of relapsed/refractory acute myeloid leukemia in adult patients (intensive chemotherapy amsacrine-cytarabine or azacitidine according to investigator's willingness) results in a significant improvement of the overall survival.
Detailed description
The prognosis for patients with relapsed or refractory acute myeloid leukemia is poor ; median survival is less than 1 year. High-dose cytarabine monotherapy or cytarabine-based combination regimens are often used as salvage therapy with limited efficacy. A recent retrospective study has shown that the addition of dexamethasone to intensive chemotherapy was significantly associated with better disease-free and overall survival in hyperleukocytic acute myeloid leukemia patients. The gene signatures of some molecular subgroups of acute myeloid leukemia were highly enriched in genes responsive to dexamethasone, including acute myeloid leukemia with NPM1 mutations which were particularly sensitive to the antileukemic activity of dexamethasone both in vitro and in vivo. Moreover, three recent preclinical studies have shown that cytarabine-resistant or RUNX1-mutated acute myeloid leukemia cells acquired sensitivity to glucocorticoids. Therefore, dexamethasone might sensitize leukemic stem cells to chemotherapy-induced cell death and thus limit the risk of relapse.
This study consists of a screening period, a treatment period, and a post-treatment follow-up period. Adult patients with relapsed/refractory acute myeloid leukemia are randomly assigned in a 1:1 ratio to receive either standard salvage therapy in combination with dexamethasone or standard salvage therapy alone. Standard salvage therapy is intensive chemotherapy (amsacrine-cytarabine) or azacitidine according to the investigator's willingness. For those patients with intensive chemotherapy amsacrine-cytarabine, the study treatment period includes 1 induction cycle and up to 3 consolidation cycles. For those patients with azacitidine, the study treatment period includes 3 cycles prior to the evaluation of the complete remission and thereafter lasts until progression. Of note, any patients in the study can undergo allogeneic hematopoietic stem cell transplantation providing his/her disease is controlled. After discontinuing the study treatment all patients must further carry out post-treatment follow-up visits every 3 months during the first and second year, and every 6 months thereafter until death, withdrawal of consent, loss to follow-up, or the end of the study, whichever occurs first. The end of the study is planned 5 years after the randomization of the first patient. The primary endpoint is the overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard salvage therapy + dexamethasone | Experimental | Drug: Dexamethasone, Drug: Amsacrine, Drug: Cytarabine, Drug: AzacitidineIntensive chemotherapy amsacrine-cytarabine or azacitidine according to the investigator's willingness in combination with dexamethasone |
| Standard salvage therapy alone | Active comparator | Drug: Amsacrine, Drug: Cytarabine, Drug: AzacitidineIntensive chemotherapy amsacrine-cytarabine or azacitidine according to the investigator's willingness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- At least 18 years of age or older
- Diagnosis of acute myeloid leukemia by World Health Organization classification
- First relapsed or refractory acute myeloid leukemia with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, and meeting the following criteria:
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Left ventricular ejection fraction ≥ 50% by echocardiogram or multi-gated acquisition scan ; only applicable for patients who will receive intensive chemotherapy.
Key exclusion criteria (15 listed)
- Acute promyelocytic leukemia (M3 subtype of acute myeloid leukemia).
- More than 2 cycles of first line induction chemotherapy.
- Acute myeloid leukemia with Philadelphia chromosome or BCR-ABL1 or blast crisis stage of chronic myeloid leukemia.
- Known or suspected central nervous system leukemia.
- Undergoing allogeneic hematopoietic stem cell transplantation within 90 days prior to randomization, or being on immunosuppressive therapy for prophylaxis of graft-versus-host disease, or experiencing graft-versus-host disease within 2 weeks prior to randomization.
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 |
|---|---|---|
| DexamethasoneIn combination with intensive chemotherapy amsacrine-cytarabine: * Induction (1 cycle): 10 mg/12h from Day 1 to Day 3 of cycle (2 infusions/24h, slow IV [10 minutes]) * Consolidation (3 cycles): 10 mg/12h from Day 1 to Day 3 of each cycle (2 infusions/24h, slow IV [10 minutes]) In combination with azacitidine: * Cycle 1: 20 mg/24h from Day 1 to Day 3 of cycle (1 infusion/24h, slow IV [10 minutes]). * Subsequent cycles: 20 mg/24h on Day 1 of each cycle (1 infusion/24h, slow IV [10minutes]). | Drug | Standard salvage therapy + dexamethasone |
| Amsacrine* Induction (1 cycle): 200 mg/m2/24h from Day 1 to Day 3 of cycle (slow IV [3 hours]) * Consolidation (3 cycles): 200 mg/m2/24h on Day 1 of each cycle (slow IV [3 hours]) | Drug | Standard salvage therapy + dexamethasone, Standard salvage therapy alone |
| CytarabinePatients < 60 years of age: * Induction (1 cycle): 3 g/m2/12h from Day 1 to Day 4 of cycle (2 infusions/24h, slow IV [2 hours]) * Consolidation (3 cycles): 3 g/m2/12h from Day 1 to Day 3 of each cycle (2 infusions/24h, slow IV [2 hours]) Note: If the investigators believe that there is an undue risk for the safety of a patient under 60 years of age with comorbidity in receiving a dose level of 3 g/m2/12h, the dose may be reduced to 1 g/m2/12h | Drug | Standard salvage therapy + dexamethasone, Standard salvage therapy alone |
| Azacitidine75 mg/m2/24h from Day 1 to Day 7 of each cycle [or from Day 1 to Day 5 and from Day 8 to Day 9 of each cycle] (SC) | Drug | Standard salvage therapy + dexamethasone, Standard salvage therapy alone |
Primary outcome
Overall survival
Time frame: Up to 60 months
Time from the date of randomization to the date of death from any cause
8 secondary outcomes
Response to therapy
Time frame: Up to 60 months
Minimal residual disease positivity
Time frame: Up to 60 months
Number of patient who realize allogeneic hematopoietic stem cell transplantation
Time frame: Up to 60 months
Duration of remission
Time frame: Up to 60 months
Relapse-free survival
Time frame: Up to 60 months
Event-free survival
Time frame: Up to 60 months
Quality of life with leukemia questionnaire
Time frame: At baseline, through complete remission, on Day 1 before dosing of each post-remission cycle, at 60 months
Adverse events
Time frame: During 60 months
Results and safety
The study was stopped early (reason given: Despite a recruitment target that was not met, we managed to achieve more than 50% of inclusions and 33% of deaths, enabling us to carry out an initial analysis of the primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Christian RECHER, PhD study director
University Hospital, Toulouse
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone, Amsacrine and Cytarabine in people with Relapsed or Refractory Acute Myeloid Leukemia, run by University Hospital, Toulouse at 10 sites 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 18 inclusion and 15 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: stopped early, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Despite a recruitment target that was not met, we managed to achieve more than 50% of inclusions and 33% of deaths, enabling us to carry out an initial analysis of the primary endpoint). Results are not available in the source record.
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?
Overall survival (time frame: Up to 60 months). 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 10 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.