Phase 2
Completed N=63
Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT00867087 ↗Enrolled (actual)
63
Serious AEs
46.0%
Results posted
Aug 2017
Primary outcomePrimary: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy — 28.6 Percentage of Participants
Summary
The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy |
28.6 | — |
| SECONDARY Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy |
39.1 | — |
| SECONDARY Kaplan-Meier Estimate of PFS 2 Years After Inotuzumab Ozogamicin Plus Rituximab Therapy |
25.3 | — |
| SECONDARY Percentage of Participants With a Response of CR or PR and Who Had Successful Granulocyte Colony Stimulating Factor (G-CSF) Mobilization of Peripheral Blood Stem Cells (PBSCs) Overall and After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy |
17.5; 15.9 | — |
| SECONDARY Percentage of Participants With Successful G-CSF Mobilization of PBSC |
28.6 | — |
| SECONDARY Percentage of Participants Who Underwent Autologous Stem Cell Transplant (aSCT) |
28.6 | — |
| SECONDARY Event-Free Survival (EFS) After aSCT |
NA | — |
| SECONDARY Percentage of Participants With a CR After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy |
12.7 | — |
| SECONDARY Overall Survival (OS) |
12.5 | — |
| SECONDARY Percentage of Participants With Any Grade 3/4 Laboratory Abnormality During Therapy |
92.1 | — |
| SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment |
100.0; 34.9; 90.5; 27.0; 11.1; 9.5 | — |
Eligibility Criteria
Inclusion Criteria
- CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy
- Relapsed/disease progression within 12 months after start of prior therapy and/or secondary International Prognostic Index (sIPI) score greater than 1
- Eligible for autologous stem cell transplant (aSCT)
Exclusion Criteria
- Prior allogeneic hematopoietic stem cell transplant
- Within 6 months prior to test article: autologous transplant, treatment with anti-CD22 antibodies, radio-immunotherapy
- Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis B or C infection
Data sourced from ClinicalTrials.gov (NCT00867087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.