Acute Myeloid LeukemiaNCT01770158
Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)
An observational study of Acute Myeloid Leukemia, run by University of Ulm at 22 sites in Germany.
Trial summary
This is a non-interventional multi-center study (NIS) in adult patients with AML in first complete remission with measurable minimal residual disease (MRD). Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 8 participants
- Where
- 22 sitesGermany
- Study dates
- Oct 2012to 27 Mar 2018
- Phase
- Observational
- 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
Study population: Adult patients with acute myeloid leukaemia (AML) in first remission following completion of consolidation therapy and concomitantly treated with interleukin-2 (IL-2) which will receive treatment with CEPLENE® for the first time. Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation.
Patient eligibility criteria in accordance to the summary of Product Characteristics:
- Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification (including de novo AML, t-AML and s-AML) in first complete remission (defined as less than 5% blasts in a normocellular bone marrow assessed prior to the treatment start)
- AMLSG BiO participation incl. favourable opinion
- Presence of NPM1 mutation, CBFB-MYH11 or MLL-AF9 fusion genes as assessed in one of the central AMLSG reference laboratories.
- Measurable MRD values (non-negative values after consolidation therapy or increase in values over the threshold during follow-up in complete remission)
- The patient must be informed of the observation and written informed consent regarding data privacy obtained.
- Consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and all other treating physicians about observation participation
- No continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Germany22 sites
Vivantes Hospital Neukölln
Berlin, 12351
Charite, University Medical School of Berlin
Berlin, 13353
Darmstadt Clinic
Darmstadt, 64283
University Hospital of Düsseldorf
Düsseldorf, 40225
Malteser Krankenhaus St. Franziskus Hospital
Flensburg, 24939
University of Freiburg
Freiburg im Breisgau, 79106
Wilhelm-Anton-Hospital gGmbH Goch
Goch, 47674
Klinikum Region Hannover GmbH, Krankenhaus Siloah
Hanover, 30449
Hannover Medical School
Hanover, 30625
Saarland University Medical Center
Homburg/Saar, 66421
Städtisches Klinikum Karlsruhe gGmbH
Karlsruhe, 76133
University Medical Center Schleswig Holstein
Kiel, 24116
Caritas-Krankenhaus Lebach
Lebach, 66822
Hospital of Lüdenscheid
Lüdenscheid, 58515
University Clinic Magdeburg
Magdeburg, 39120
University Hospital rechts der Isar
München, 81675
Hospital of Schwäbisch Gmünd
Mutlangen, 73557
Hospital of Passau
Passau, 94032
Hospital of Traunstein
Traunstein, 83278
Klinikum Mutterhaus der Borromäerinnen
Trier, 54290
University Hospital of Ulm
Ulm, 89520
Helios Klinikum Wuppertal
Wuppertal, 42283
About this study
This is a non-interventional multi-center study (NIS) in adult patients with AML in first complete remission with measurable minimal residual disease (MRD). Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first complete remission. Therapy is administered for 10 treatment cycles as outlined in the Summary of Product Characteristics.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia (AML), Histamine Dihydrochloride, Interleukin-2
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
leukemia-free survival / cumulative incidence of relapse
Measured: two years
Secondary outcomes (2)
Toxicity induced by the preemptive treatment with Ceplene and IL-2
Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization
Measured: 18 months
Overall survival
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 posted17 Jan 2013 (estimated)
- Study startOct 2012
- Primary completion27 Mar 2018
- Study completion27 Mar 2018
Why it stopped: Recruitment goal cannot be achieved any more as only 8 patients have been recruited since start of the study in 2012.
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Greiner, University of Ulm
- Investigators
- Jochen Greiner, MD, Principal investigator, University Hospital of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770158
- Sponsor's protocol ID
- AMLSG18-12
- Status last verified
- Apr 2018
- First submitted
- 9 Oct 2012
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)
- ClinicalTrials.gov ID
- NCT01770158
- Acronym / sponsor ID
- AMLSG18-12
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia (AML), Histamine Dihydrochloride, Interleukin-2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment goal cannot be achieved any more as only 8 patients have been recruited since start of the study in 2012.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 17 Jan 2013 (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.
This is a non-interventional multi-center study (NIS) in adult patients with AML in first complete remission with measurable minimal residual disease (MRD). Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first complete remission. Therapy is administered for 10 treatment cycles as outlined in the Summary of Product Characteristics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with acute myeloid leukaemia (AML) in first remission following completion of consolidation therapy and concomitantly treated with interleukin-2 (IL-2) which will receive treatment with CEPLENE® for the first time. Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
leukemia-free survival / cumulative incidence of relapse
Time frame: two years
2 secondary outcomes
Toxicity induced by the preemptive treatment with Ceplene and IL-2
Time frame: 18 months
Overall survival
Time frame: two years
Results and safety
The study was stopped early (reason given: Recruitment goal cannot be achieved any more as only 8 patients have been recruited since start of the study in 2012.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
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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.
Jochen Greiner, MD principal investigator
University Hospital of Ulm
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by University of Ulm at 22 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany. 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.
Are results available for this study?
The study was stopped early (reason given: Recruitment goal cannot be achieved any more as only 8 patients have been recruited since start of the study in 2012.). 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?
leukemia-free survival / cumulative incidence of relapse (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 9 Apr 2018.