B1931022 Inotuzumab in Acute Lymphoblastic Leukaemia

• Research type

  Research Study

• Full title

  An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator’s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)

• IRAS ID

  104074

• Contact name

  David Marks

• Sponsor organisation

  Pfizer Inc , 235 East 42nd Street, New York, NY 10017,USA

• Eudract number

  2011-005491-41

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Inotuzumab Ozogamicin is an investigational drug that is currently not for sale. Early studies have shown that Inotuzumab Ozogamicin may be able to help patients who have Acute Lymphoblastic Leukaemia (ALL). Study B1931022 is for patients who??s whose leukaemia has either come back (relapsed) or has not responded to the most recent treatment (refractory). The main purpose of this research study is to learn if Inotuzumab Ozogamicin is a more effective treatment when compared to chemotherapy regimens commonly used in patients with relapsed or refractory ALL. It is also intended to help researchers learn more about the side effects associated with Inotuzumab Ozogamicin treatment and how this drug is distributed through the patient??s body (pharmacokinetics (PK). Patients who enter the study will be assigned by chance to receive either Inotuzumab Ozogamicin or one of three standard chemotherapy regimens. Patients may receive a maximum of 6 cycles of Inotuzumab Ozogamicin , or up to 4 cycles of chemotherapy. After treatment is completed or discontinued, there is a 2-year follow up period during which the study doctor will collect blood and tumour samples to monitor the response to the therapy received. During the first year, patients will be asked to come to the clinic approximately every 12 weeks and in the second year, approximately every 24 weeks. About 292 subjects will be in this study from about 25 countries and the research will be paid for by Pfizer , the manufacturer of Inotuzumab Ozogamicin. The study doctor and the sponsor will be reviewing the data from the study regularly to make sure the treatments are safe and effective.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  12/SC/0309

• Date of REC Opinion

  30 Jul 2012

• REC opinion

  Further Information Favourable Opinion