Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia
|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: NCT01347996|
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : November 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: histamine dihydrochloride and IL-2||Phase 4|
- To assess the quantitative and qualitative pharmacodynamic effects of Ceplene plus low-dose IL-2 (Ceplene/IL-2) by monitoring T and natural killer (NK) cell phenotypes and their functionality after the first and third treatment cycles in adult patients with acute myeloid leukemia (AML) in first complete remission (CR1).
- To evaluate minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2.
To document, in adult AML patients in CR1 treated with Ceplene/IL-2:
- Leukemia-free survival (LFS) after a follow-up period of up to two years.
- The safety of Ceplene/IL-2 therapy.
- The potential relationship of Ceplene/IL-2 effects on T and NK cell phenotypes and their functionality to MRD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Multicenter, Effects of Remission Maintenance Therapy With Ceplene® , Given in Conjunction With Low-Dose Interleukin-2, on Immune Response and Minimal Residual Disease in Adult Patients With AML in First Complete Remission|
|Study Start Date :||July 2009|
|Primary Completion Date :||June 2014|
|Study Completion Date :||June 2014|
Experimental: histamine dihydrochloride and IL-2
histamine and IL-2 subcutaneous injections
Drug: histamine dihydrochloride and IL-2
Ceplene 0.5 mg subcutaneously twice daily and IL-2 1 µg/kg [16,400 IU/kg] body weight twice daily for 10, 21 day cycles
- Minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2 [ Time Frame: Comparison at baseline and various time points up to 2 years ]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.
- 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 [ Time Frame: Baseline vs Cycle 1 and 3 ]
The quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2 on the immune responses of T and NK cells will be assessed as follows:
- 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.
- 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
- Duration of LFS [ Time Frame: up to 2 years ]Duration of LFS: LFS will be defined as the time from achieving CR after successful induction therapy until relapse of AML (defined as 5% or more blast cells in the bone marrow).
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): NCT01347996
|Sahlgrenska Academy, University of Gothenburg|
|Study Chair:||Robin FOA, MD, PhD||Università degli Studi di Roma "La Sapienza" Dipartimento di Biotecnologie Cellulari ed Ematolgia|
|Principal Investigator:||Mats L Brune, MD, PhD||Sahlgrenska Academy University of Gothenburg, Gothenburg, Sweden|