Acute Myeloid Leukemia, in RelapsePhase 2NCT03053206
A Prospective, Interventional Study Assessing Response to Cytarabine, Daunorubicin and Etoposide (ADE) for First Relapse of Paediatric Acute Myeloid Leukemia
A Phase 2 study testing ADE Protocol in people with Acute Myeloid Leukemia, in Relapse, run by All India Institute of Medical Sciences.
Trial summary
One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Myeloid Leukemia, in Relapse
- What is being tested?
- ADE Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2017to 31 Dec 2019
- Phase
- Phase 2
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Either gender with age ≤18 years at initial diagnosis
- AML(non-M3) patients at first relapse (medullary)
Who cannot join
- Primary refractory AML \&secondary AML
- More than or equal to 2 relapses of AML
- Symptomatic cardiac dysfunction (CTCAE Grade 3 or 4)
- Active infection(pneumonia etc.)
- Any other organ dysfunction (CTCAE Grade 4)
- Patients not willing to consent for the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AML
One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active agents in AMLand have been used as monotherapy and in combination in refractory and relapsed AML patients. According to previous studies the present CR rate of different regimens ranges from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.
- Conditions
- Acute Myeloid Leukemia, in Relapse
- Being tested
- ADE Protocol
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADE ProtocolDrug
ADE chemotherapy
Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days
| Study group | Role | What they receive |
|---|---|---|
| ADE arm | Experimental | ADE arm
Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days Receives: Drug: ADE Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission (CR) rate
To assess the complete remission (CR) rate with the use of ADE chemotherapy in relapsed acute myeloid leukemia (AML) after first CR
Measured: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
Secondary outcomes (5)
Event free survival (EFS) and overall survival(OS)
To determineevent free survival(EFS) and overall survival(OS)
Measured: 2 year
toxicity of chemotherapy
To assess the toxicity of chemotherapy using CTCAE 4.0
Measured: Day 28 ± 7 of treatment
clonal evolution
To evaluate clonal evolution using cytogenetics \&RT-PCR panel
Measured: Day 28 ± 7 of treatment
minimal residual disease (MRD)
To assess minimal residual disease (MRD) by using flow cytometry
Measured: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
cardiac function
To evaluate cardiac function using 2 Dimensional Echocardiography
Measured: Day 28 ± 7 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start15 Feb 2017 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, in RelapseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARUN GARG, MD, DM, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053206
- Sponsor's protocol ID
- IECPG-660/22.12.2016
- Status last verified
- Feb 2017
- First submitted
- 7 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AML
- ClinicalTrials.gov ID
- NCT03053206
- Acronym / sponsor ID
- IECPG-660/22.12.2016
- Conditions
- Acute Myeloid Leukemia, in Relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 15 Feb 2017 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 Feb 2017 (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.
One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active agents in AMLand have been used as monotherapy and in combination in refractory and relapsed AML patients. According to previous studies the present CR rate of different regimens ranges from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADE arm | Experimental | Drug: ADE ProtocolADE arm Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Either gender with age ≤18 years at initial diagnosis
- AML(non-M3) patients at first relapse (medullary)
Key exclusion criteria (6 listed)
- Primary refractory AML \&secondary AML
- More than or equal to 2 relapses of AML
- Symptomatic cardiac dysfunction (CTCAE Grade 3 or 4)
- Active infection(pneumonia etc.)
- Any other organ dysfunction (CTCAE Grade 4)
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 |
|---|---|---|
| ADE ProtocolADE chemotherapy Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days | Drug | ADE arm |
Primary outcome
complete remission (CR) rate
Time frame: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
To assess the complete remission (CR) rate with the use of ADE chemotherapy in relapsed acute myeloid leukemia (AML) after first CR
5 secondary outcomes
Event free survival (EFS) and overall survival(OS)
Time frame: 2 year
toxicity of chemotherapy
Time frame: Day 28 ± 7 of treatment
clonal evolution
Time frame: Day 28 ± 7 of treatment
minimal residual disease (MRD)
Time frame: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
cardiac function
Time frame: Day 28 ± 7 of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADE Protocol in people with Acute Myeloid Leukemia, in Relapse, run by All India Institute of Medical Sciences.
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 2 inclusion and 6 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 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 ARUN GARG, DM (9968588792, arungarg_aiims@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission (CR) rate (time frame: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier). 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 15 Feb 2017.