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The phase 2 injection doses of IMA901 per peptide and GM-CSF were identical to the phase 1 study, however formulation in the phase 2 study excluded the marker peptide HBV-001.
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There were 24 withdrawals from the MMF group (12 due to infection) and 13 from the cyclophosphamide group (4 due to infection).
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Since platinum-containing species are eliminated primarily through the kidney, clearance of these products may be decreased by co-administration of potentially nephrotoxic compounds, although this has not been specifically studied.
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Median overall survival from diagnosis is approximately 3 years, but with clinically overt cardiac involvement this is reduced to 1 year.
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The primary end point was safety, with infusion-related reactions (88%, grade 3-4 20%) being the most common adverse event and grade 3-4 neutropenia in 55% on G-B and 48% on G-FC.
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The primary objectives in phase I were to determine the MTD, DLT and the recommended phase 2 dose (RP2D) of clofarabine when used in combination with etoposide and cyclophosphamide.
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In Stage IV (widespread disease), the lymphoma has spread (metastasized) via the bloodstream to organs outside the lymph system, such as the bone marrow, brain, skin, or liver.
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Patients in the control group who had a remission between 3 and 6 months were eligible to switch from cyclophosphamide to azathioprine (2 mg per kilogram per day).
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The results suggested that SIP not only improved expression of keap1 gene in testes of normal mice, but also positively affected contents of the protein in testes of chemotherapeutic mice, which was subjected to resisting expression increase of Nrf2 gene.
For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity.
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