Besponsa in clinical trials. The European Commission (EC) approved Besponsa on June 30, 2017. The U.S. Food and Drug Administration (FDA) did likewise on Aug. 17, 2017. These approvals were largely based on positive results seen in a Phase 3 trial (NCT01564784) called INO-VATE ALL. This was a randomized, open-label, multicenter study comparing the efficacy and safety of Besponsa to chemotherapy in 326 patients with CD22-positive ALL.. Clinical trials. Clinical trials study whether an investigational therapy may offer a benefit to patients. IMPORTANT SAFETY INFORMATION AND INDICATION View More. WARNING: RISK OF LIVER PROBLEMS AND INCREASED RISK OF DEATH AFTER STEM CELL TRANSPLANT. BESPONSA can cause liver problems that can be severe, life-threatening, or fatal, including a condition called veno-occlusive disease (VOD). This . Besponsa Clinical Trials, 36 Results, Page 1 Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia. However, in draft guidelines, NICE says evidence from clinical trials showed no survival benefit from Besponsa compared to current treatment, but more people who were treated with the drug were able to subsequently have a stem cell transplant and go into remission than those on standard care.. This trial is a limited multi-center, Phase II study to evaluate inotuzumab ozogamicin (Besponsa) in pediatric patients with MRD positive CD22-positive B-lymphoblastic leukemia (B-ALL).. However, in draft guidelines released in June last year, the Institute argued that evidence from clinical trials showed no survival benefit from Besponsa compared to current treatment, but did note that more people who were treated with the drug were able to subsequently have a stem cell transplant and go into remission than those on standard care..