Acute Myeloid LeukemiaPhase 1/2NCT01369368
Treatment of Acute Leukemia Relapse After Allotransplantation
A Phase 1/2 study testing Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions. in people with Acute Myeloid Leukemia, run by University of Bergen at 1 site in Norway.
Trial summary
Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to Oct 2020
- Phase
- Phase 1/2
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML relapse within one year after transplantation
- Blood and marrow sampling being possible
- Expected survival at least 4 weeks
- No expected drug interactions
- Informed consent possible
Who cannot join
- Intolerance to any study drug
- Serious kidney or liver disease
- Informed consent not possible
- Previous pancreatitis
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, N-5021
Oystein Bruserud, MD
About this study
Official title: Treatment of Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation: Disease Stabilization Through Chemotherapy, Immunomodulatory Treatment and Immunotherapy
Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.
- Keywords
- Acute myeloid leukemia, Allogeneic stem cell transplantation, Relapse, Disease stabilization, survival
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.Drug
Also called Give as repeated cycles with 5 weeks intervals. Donor leukocyte infusions are allowed from cycle 2.
Azacitidine 100 mg day 1-3 in each cycle Valproic acid, continuous therapy from day 1 All-trans retinoic acid 22.5 mg/m2 twice daily day 1-14 in each cycle Hydroxurea 500 mg initially eventually increased to 1 g daily. Eventually donor leukocyte infusions on day 10 from the second cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Azacitidine, valproic acid, all-trans retinoic acid, hydroxyurea, eventually donor leukocyte infusions Receives: Drug: Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease stabilization
Strict criteria defined in the protocol.
Measured: 5 years
Secondary outcomes (1)
Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startAug 2013
- Primary completionOct 2017 (estimated)
- Study completionOct 2020 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Øystein Bruserud, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369368
- Sponsor's protocol ID
- Allo-Relapse-2011
- Status last verified
- Jun 2015
- First submitted
- 7 Jun 2011
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation: Disease Stabilization Through Chemotherapy, Immunomodulatory Treatment and Immunotherapy
- ClinicalTrials.gov ID
- NCT01369368
- Acronym / sponsor ID
- Allo-Relapse-2011
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, Allogeneic stem cell transplantation, Relapse, Disease stabilization, survival
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 8 Jun 2011 (estimated)
- 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.
Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.Azacitidine, valproic acid, all-trans retinoic acid, hydroxyurea, eventually donor leukocyte infusions |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AML relapse within one year after transplantation
- Blood and marrow sampling being possible
- Expected survival at least 4 weeks
- No expected drug interactions
- Informed consent possible
Key exclusion criteria (4 listed)
- Intolerance to any study drug
- Serious kidney or liver disease
- Informed consent not possible
- Previous pancreatitis
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 |
|---|---|---|
| Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.Also: Give as repeated cycles with 5 weeks intervals. Donor leukocyte infusions are allowed from cycle 2.Azacitidine 100 mg day 1-3 in each cycle Valproic acid, continuous therapy from day 1 All-trans retinoic acid 22.5 mg/m2 twice daily day 1-14 in each cycle Hydroxurea 500 mg initially eventually increased to 1 g daily. Eventually donor leukocyte infusions on day 10 from the second cycle. | Drug | 1 |
Primary outcome
Disease stabilization
Time frame: 5 years
Strict criteria defined in the protocol.
1 secondary outcome
Survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions. in people with Acute Myeloid Leukemia, run by University of Bergen at 1 site in Norway.
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 4 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 24 Jun 2015. 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 Norway. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Oystein Bruserud, MD (0047 55975000, oystein.bruserud@haukeland.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease stabilization (time frame: 5 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 24 Jun 2015.