Acute Myeloid LeukemiaAMLNCT03902769
Study to Assess Length of Remission With Intensive Chemotherapy in Rapidly Responding AML Patients.
A study testing Prescribing conventional chemotherapy while with holding allo-SCT in people with Acute Myeloid Leukemia, run by Rambam Health Care Campus.
Trial summary
We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). Read more about this study
- Who is it for?
- Ages 18 to 61 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Prescribing conventional chemotherapy while with holding allo-SCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2019to 1 Nov 2023
- Phase
- Interventional
- 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 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- AML diagnosis,
- treated with 3+7 Induction chemotherapy
- Intermediate/standard risk AML
Who cannot join
- Diagnosed of APL
- high risk molecular/cytogenetic score
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II Prospective Study to Assess Rate for Prolonged Remission With Intensive Chemotherapy in Rapid Respondents AML Patients Younger Than 61 as Demonstrated by Day 5 Examination of the First Treatment.
We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). The long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).
Read the detailed description
Patients diagnosed with AML, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk AML, will undergo BM examination on the fifth day of induction. Patients in whom BM blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous SCT with-holding the option for allo-SCT. MRD monitoring will apply to those with reliable molecular marker.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Prescribing conventional chemotherapy while with holding allo-SCT
- 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.
Prescribing conventional chemotherapy while with holding allo-SCTProcedure or surgery
Also called No Allogeneic for rapid responders
Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT
| Study group | Role | What they receive |
|---|---|---|
| No allogeneic SCT | Experimental | For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan Receives: Procedure: Prescribing conventional chemotherapy while with holding allo-SCT |
| Standard post induction therapy | Active comparator | For slow responding AML patients, post induction therapy will be provided according to treating physician discretion Receives: Procedure: Prescribing conventional chemotherapy while with holding allo-SCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Measured: Two years
Secondary outcomes (1)
Overall survivial
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start15 Apr 2019 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- One arm open study
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yishai Ofran, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902769
- Sponsor's protocol ID
- RMB-250-18
- Acronym
- AML
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 8 Apr 2019
- 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 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Prospective Study to Assess Rate for Prolonged Remission With Intensive Chemotherapy in Rapid Respondents AML Patients Younger Than 61 as Demonstrated by Day 5 Examination of the First Treatment.
- ClinicalTrials.gov ID
- NCT03902769
- Acronym / sponsor ID
- AML / RMB-250-18
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 15 Apr 2019 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 4 Apr 2019 (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.
We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). The long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).
Detailed description
Patients diagnosed with AML, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk AML, will undergo BM examination on the fifth day of induction. Patients in whom BM blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous SCT with-holding the option for allo-SCT. MRD monitoring will apply to those with reliable molecular marker.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One arm open study
| Arm | Type | Receives |
|---|---|---|
| No allogeneic SCT | Experimental | Procedure: Prescribing conventional chemotherapy while with holding allo-SCTFor standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan |
| Standard post induction therapy | Active comparator | Procedure: Prescribing conventional chemotherapy while with holding allo-SCTFor slow responding AML patients, post induction therapy will be provided according to treating physician discretion |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- AML diagnosis,
- treated with 3+7 Induction chemotherapy
- Intermediate/standard risk AML
Key exclusion criteria (2 listed)
- Diagnosed of APL
- high risk molecular/cytogenetic score
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 |
|---|---|---|
| Prescribing conventional chemotherapy while with holding allo-SCTAlso: No Allogeneic for rapid respondersPrescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT | Procedure or surgery | No allogeneic SCT, Standard post induction therapy |
Primary outcome
Event free survival
Time frame: Two years
1 secondary outcome
Overall survivial
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- 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 study testing Prescribing conventional chemotherapy while with holding allo-SCT in people with Acute Myeloid Leukemia, run by Rambam Health Care Campus.
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 3 inclusion and 2 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 8 Apr 2019. 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.
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 Yishai Ofran, MD (+972-4-7778026, y_ofran@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: Two 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 8 Apr 2019.