Ph 1b Combo Dinaciclib+Rituximab in CLL/SLL

• Research type

  Research Study

• Full title

  A Phase 1b Trial of Dinaciclib in Combination with Rituximab in Subjects with Relapsed and Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.

• IRAS ID

  110551

• Contact name

  Saman Hewamana

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2012-001437-14

• ISRCTN Number

  n/a

• Research summary

  Chronic Lymphocytic Leukaemia (CLL) is the most common type of leukaemia in Western Countries. Small Lymphocytic Lymphoma (SLL) was recently categorised together with CLL making its designation a single disease. CLL and SLL are cancers of B lymphocytes (a type of white blood cell). In this disease, the lymphocytes multiply too quickly and live for too long, so there are too many of them circulating in the blood. The cancerous lymphocytes are not fully developed and do not work properly. Over time, the abnormal cells replace normal blood cells. This is a Phase 1b non randomised, open label, multi-site trial to determine the tolerable dose of an experimental drug known as Dinaciclib in combination with rituximab in adult subjects with relapsed and refractory CLL/SLL. The study will be conducted in two parts. Part 1 will establish the maximum tolerated dose (MTD) of Dinaciclib when given in combination with rituximab. If five or more responses are seen in the first 12 participants at the MTD the trial will continue with part 2. In part 2 the overall response rate will be explored. Treatment will be divided into 13 cycles. Each cycle is 28 days. Participants will receive rituximab via an intravenous (IV) infusion on Days 1, 8, 15 and 22 in cycle 1. Dinaciclib as an IV infusion on days 1, 8 and 15 in cycle 2. Dinaciclib and rituximab in combination on day 1 of cycles 3 to 13 and Dinaciclib only on days 8 and 15 of cycles 3 to 13. Safety and tolerability will be assessed during the study by reviewing adverse events, laboratory tests, vital signs and ECG measurements. Response to treatment will be assessed every 12 weeks using the results of the participants CT scan, haematology laboratory results and presence of CLL symptoms. World-wide about 42 patients will be enrolled in the study. In the UK the Royal Marsden Foundation NHS Trust will participate in the study.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/1779

• Date of REC Opinion

  23 Jan 2013

• REC opinion

  Further Information Favourable Opinion