Clinical TrialID 6908
Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia
NCT01347996
Acute Myeloid Leukemia
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6908
- Evidence Id
- 6908
- Core Evidence Id
- 6908
- Source Clinical Trial Id
- 6900
- Herb2 Clinical Trial Id
- HBCT006900
- Nct Id
- NCT01347996
- Title
- Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia
- Status
- Completed
- Phase
- Phase 4
- Study Result
- No
- Study Condition
- Acute Myeloid Leukemia
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: histamine dihydrochloride and IL-2
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 84
- Outcome Measure
- Minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2, A second primary objective of this study is to evaluate MRD in patients who are receiving remission maintenance therapy with Ceplene/IL-2. MRD will be evaluated using RQ-PCR for molecular detection of genetic markers of AML. Patients' MRD status will be quantified at the time of enrollment (baseline) and within ten days after completion of Cycles 3, 5, 6, 7, 9 and 10 of Ceplene/IL-2 therapy, corresponding to approximately every 3 months during this immunotherapy., Comparison at baseline and various time points up to 2 years|Pharmacodynamic effects of Ceplene plus low dose IL-2 (Ceplene/IL-2) by monitoring T and NK cell phenotypes and their functionality after the first and third cycles of treatment, The quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2 on the immune responses of T and NK cells will be assessed as follows: 1. Changes in T and NK cell phenotypes (CD56, CD3, CD4, CD8) in peripheral blood from Day 1 (baseline) to Day 21‡ of Cycle 1 and from Day 1 (pre-treatment Cycle 3) to Day 21‡ of Cycle 3. 2. Changes in immune response markers (CD3, NKp46 \[and other NCRs\], CD25, CD69, and IFN-γ) in peripheral blood from Day 1 (baseline) to Day 21‡ of Cycle 1 and from Day 1 (pre-treatment Cycle 3) to Day 21‡ of Cycle 3, Baseline vs Cycle 1 and 3
- Sponsor Collaborator
- Cytovia, Inc.|EpiCept Corporation
- Funded By
- OTHER
- Location
- Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Other Id
- EPC2008-02
- Start Date
- 2009-07
- Primary Completion Date
- 2014-06
- Completion Date
- 2014-06
- First Posted
- 2011-05-05
- Results First Posted
- Last Update Posted
- 2017-11-29
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01347996
- Title Cn
- Title En
- Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia
- Bilingual Status
- semi_complete