This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.

Information on clinical trials and how to participate in a clinical trial. Clinical trials are a part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Trea

Patients log in from anywhere, on any device 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). Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6 week rest periods. All subjects will be assigned to one of three consecutive cohorts, each comprising five patients. Ceplene maintainance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2).

Ceplene clinical trial

The potential relationship of Ceplene/IL-2 effects on T and NK cell phenotypes and their functionality to MRD. Ceplene is currently being tested in a Phase 3 cancer clinical trial for advanced malignant melanoma with liver metastasis. Phase 2 trials of Ceplene are also underway for the treatment of Immune to begin phase I/II trial of Ceplene in patients with chronic myelomonocytic leukemia: New York Thursday, June 22, 2017, 14:00 Hrs [IST] Immune Pharmaceuticals, a clinical stage biopharmaceutical company, announced that patient enrollment in a phase I/II clinical trial evaluating the safety and efficacy of Ceplene (histamine dihydrochloride) in patients with Chronic Myelomonocytic For the Phase I study: To evaluate the safety and tolerability of vidaza and Ceplene/IL-2 used together. For the phase II study: To determine if maintenance treatment with vidaza and Ceplene/IL-2 can improve, compared to maintenance treatment with vidaza alone, the time to progression in adult patients with higher risk MDS who achieved a response (CR, PR, mCR or HI according to IWG 2006 Results of the Re:Mission trial (NCT01347996) supported previous studies indicating that a combination of Ceplene (histamine dihydrochloride) and the maintenance therapy interleukin-2 can prevent or delay leukemia from returning. Health Canada, however, deemed that CEPLENE® was a “new drug” because the old medicinal ingredient histamine dihydrochloride was being employed for a new use. Epicept accordingly filed a 124-volume NDS with extensive material and data from comprehensive clinical trials. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML. Azacitidine 75 mg/m2 subcutaneously daily for 7 days every 4 weeks. Ceplene® / IL2: Patients will receive Ceplene (EpiCept Corporation, Tarrytown, NY) at 0.5 mg subcutaneous twice daily and human recombinant IL-2 (aldesleukin; Novartis) 16 400 U/kg subcutaneous twice daily during 15 days for up to 10 cycles, on days 8 to 21 of AZA cycles.

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All subjects will be assigned to one of three consecutive cohorts, each comprising five patients. Ceplene maintainance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60. IMMUNE Pharmaceuticals' Oncology Subsidiary, CYTOVIA, Announces Additional Clinical Trial Results on the Efficacy of Ceplene® in Combination with Low-Dose IL-2 in Patients With Acute Myeloid In August 2010, EpiCept Corporation announced the receipt of a Refusal to File Letter from the U.S. Food and Drug Administration (FDA), with the recommendation for company to conduct an additional confirmatory pivotal trial to establish the therapeutic contribution of Ceplene (histamine dihydrochloride) in combination with interleukin-2 (IL-2) using overall survival as a primary endpoint.

IMMUNE Pharmaceuticals' Oncology Subsidiary, CYTOVIA, Announces Additional Clinical Trial Results on the Efficacy of Ceplene® in Combination with Low-Dose IL-2 in Patients With Acute Myeloid In August 2010, EpiCept Corporation announced the receipt of a Refusal to File Letter from the U.S. Food and Drug Administration (FDA), with the recommendation for company to conduct an additional confirmatory pivotal trial to establish the therapeutic contribution of Ceplene (histamine dihydrochloride) in combination with interleukin-2 (IL-2) using overall survival as a primary endpoint. Ceplene™ just finished the last phase of clinical trials prior to FDA review for approval. Although no definitive results have yet been announced, the latest clinical trial demonstrated a significant improvement in cancer-free survival with the use of Ceplene™.
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Author information: (1)College of Pharmacy, University of Kentucky, Lexington, USA. Ceplene has been shown in clinical studies to prevent leukemic relapses in AML patients in first remission and prolong leukemia-free survival while maintaining good quality of life during treatment. This trial will investigate the efficacy and safety of histamine dihydrochloride [Ceplene] in patients with acute myeloid leukemia. An international Overall Survival clinical study with the combination of Ceplene and low dose Proleukin. 2017-06-20 · Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support The agency concluded that the NDA for Ceplene (histamine dihydrochloride) combined with low-dose interleukin-2 did not prove the drug’s effectiveness.

All subjects will be assigned to one of three consecutive cohorts, each comprising five patients. Ceplene™ just finished the last phase of clinical trials prior to FDA review for approval. Although no definitive results have yet been announced, the latest clinical trial demonstrated a significant improvement in cancer-free survival with the use of Ceplene™. The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
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Factors that may cause actual results or developments to differ materially include, but not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that clinical trials for bertilimumab or AmiKet will

Author information: (1)College of Pharmacy, University of Kentucky, Lexington, USA. Clinical trials are an important part of our research and development efforts and help make possible access to safe and potentially life-saving treatments. CLINICAL TRIALS WEBSITE This website uses cookies to improve your overall experience. Ceplene has been shown in clinical studies to prevent leukemic relapses in AML patients in first remission and prolong leukemia-free survival while maintaining good quality of life during treatment. Histamine dihydrochloride (INN, trade name Ceplene) is a salt of histamine that is used as a drug for the prevention of relapse in patients diagnosed with acute myeloid leukemia (AML). EpiCept Receives Ceplene Marketing Approval in Europe October 9, 2008 TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News: EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced This provides further mechanistic evidence to explain the striking efficacy of Ceplene ® in combination with low dose IL-2 observed clinically in the myelomonocytic M4 and M5 AML subtypes in both Phase III and Phase IV clinical trials. These results suggest that Ceplene®, in addition to its previously documented role as an innate immune check Cytovia, the oncology subsidiary of Immune Pharmaceuticals, a clinical stage biopharmaceutical company, announced the publication of clinical trial results on the use of Ceplene (histamine dihydrochloride) for relapse prevention in patients with acute myeloid leukemia (AML).