B1931008 - Agressive NHL Study

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR’S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY

• IRAS ID

  67940

• Eudract number

  2010-020147-12

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Non-Hodgkin Lymphomas (NHL) are a large group of blood cancers, which vary in severity from indolent to very aggressive. Lymphomas are types of cancer derived from lymphocytes (white blood cell). Relapsed/refractory aggressive NHL is one of the groups. These patients have failed prior chemotherapy; either the cancer has progressed or was not completely responsive. These patients are often not suitable candidates for high dose chemotherapy or autogous stem cell transplant (aSCT)due to their age and/or current health status. These patients currently have limited treatment options after they fail first line chemotherapy treatment; 5 year survival for these patients is 5-10%. For those with refractory NHL there are even less options. At present there no approved therapies but muliple treatments are used but there is insufficient data to clearly define a gold standard. Rituximab in combination with a variety of single-chemotherapeutic agents has become the standard of care in the treatment of patients with relapsed disease. Such regimens include rituximab plus bendamustine (R-bendamustine) and rituximab plus gemcitabine (R-gemcitabine). These 2 chemotherapies have demonstrated activity in phase 2, single-arm clinical trials involving subjects with relapsed/refractory aggressive NHL. The current clinical experience of inotuzumab ozogamicin in combination with rituximab(R-inotuzumab ozogamicin) suggests that this combination has similar or greater activity than that observed with other prescribed rescue therapies, and may be particularly promising for patients who are not candidates for intense HD chemo. This phase 3 trial will further evaluate the clinical activity and safety of R-inotuzumab ozogamicin in subjects with relapsed/refractory aggressive B-cell NHLs who are not candidates for intensive HD chemo ( aSCT) in comparison with 2 commonly practiced chemotherapies, R-bendamustine and R-gemcitabine. The selection of the comparators is further supported that each have well-described dose regimens (4-weekcycles), with anticipated toxicities requiring dose reductions/delays/discontinuations comparable to R-inotuzumab ozogamicin.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/SC/0141

• Date of REC Opinion

  13 Jun 2011

• REC opinion

  Further Information Favourable Opinion