Acute Myeloid LeukemiaPhase 2/3NCT01588951
Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
A Phase 2/3 study testing Cytarabine consolidation and Allogeneic transplant in people with Acute Myeloid Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Cytarabine consolidation and Allogeneic transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Apr 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Able to give informed consent
- New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2
Who cannot join
- Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
- Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
- Pregnancy: Women of childbearing potential who are β- HCG+
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
About this study
The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Cytarabine consolidation, Allogeneic transplant
- 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.
Cytarabine consolidationDrug
Also called HiDAC
Cytarabine-based consolidation per institutional standards.
Allogeneic transplantDrug
Also called Bone marrow transplant, Stem cell transplant, Hematopoietic stem cell transplant, BMT
Allogeneic stem cell transplant per institutional standards.
| Study group | Role | What they receive |
|---|---|---|
| No Leukemia Stem Cells - Consolidation | Experimental | Without LSC, standard cytarabine consolidation Receives: Drug: Cytarabine consolidation |
| Leukemia Stem Cells - Consolidation | Experimental | LSC present, randomized to cytarabine consolidation Receives: Drug: Cytarabine consolidation |
| Leukemia Stem Cells - Transplant | Experimental | LSC present, randomized to allogeneic transplant Receives: Drug: Allogeneic transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Free Survival
Percentage of participants alive and without relapsed disease at two years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startDec 2013
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Showel, MD, Study chair, JHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588951
- Sponsor's protocol ID
- J1227
- Other IDs
- NA_00071844
- Status last verified
- Jul 2018
- First submitted
- 27 Apr 2012
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
- ClinicalTrials.gov ID
- NCT01588951
- Acronym / sponsor ID
- J1227
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Leukemia Stem Cells - Consolidation | Experimental | Drug: Cytarabine consolidationWithout LSC, standard cytarabine consolidation |
| Leukemia Stem Cells - Consolidation | Experimental | Drug: Cytarabine consolidationLSC present, randomized to cytarabine consolidation |
| Leukemia Stem Cells - Transplant | Experimental | Drug: Allogeneic transplantLSC present, randomized to allogeneic transplant |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years
- Able to give informed consent
- New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2
Key exclusion criteria (3 listed)
- Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
- Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
- Pregnancy: Women of childbearing potential who are β- HCG+
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 |
|---|---|---|
| Cytarabine consolidationAlso: HiDACCytarabine-based consolidation per institutional standards. | Drug | Leukemia Stem Cells - Consolidation, No Leukemia Stem Cells - Consolidation |
| Allogeneic transplantAlso: Bone marrow transplant, Stem cell transplant, Hematopoietic stem cell transplant, BMTAllogeneic stem cell transplant per institutional standards. | Drug | Leukemia Stem Cells - Transplant |
Primary outcome
Relapse Free Survival
Time frame: 2 years
Percentage of participants alive and without relapsed disease at two years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
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AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Margaret Showel, MD study chair
JHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cytarabine consolidation and Allogeneic transplant in people with Acute Myeloid Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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 3 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 14 Aug 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 United States. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Relapse Free Survival (time frame: 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 14 Aug 2018.