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)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01770158 |
Recruitment Status :
Terminated
(Recruitment goal cannot be achieved any more as only 8 patients have been recruited since start of the study in 2012.)
First Posted : January 17, 2013
Last Update Posted : April 9, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Acute Myeloid Leukemia |
Study Type : | Observational |
Actual Enrollment : | 8 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
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) |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | March 27, 2018 |
Actual Study Completion Date : | March 27, 2018 |

- leukemia-free survival / cumulative incidence of relapse [ Time Frame: two years ]
- Toxicity induced by the preemptive treatment with Ceplene and IL-2 [ Time Frame: 18 months ]Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization
- Overall survival [ Time Frame: two years ]
- Assessment of quality of life [ Time Frame: two years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770158

Principal Investigator: | Jochen Greiner, MD | University Hospital of Ulm |
Responsible Party: | Jochen Greiner, Prof. Dr. Jochen Greiner, University of Ulm |
ClinicalTrials.gov Identifier: | NCT01770158 |
Other Study ID Numbers: |
AMLSG18-12 |
First Posted: | January 17, 2013 Key Record Dates |
Last Update Posted: | April 9, 2018 |
Last Verified: | April 2018 |
Acute myeloid leukemia (AML) Histamine Dihydrochloride Interleukin-2 |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasm, Residual |
Neoplasms by Histologic Type Neoplasms Neoplastic Processes Pathologic Processes |