Phase 2
Completed N=72
Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT01363297 ↗Enrolled (actual)
72
Serious AEs
70.8%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants Reporting Dose Limiting Toxicities (DLTs) During the Phase 1 Dose-Finding Phase — 0; 0; 11.1 Percentage of Participants
Summary
The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Dose Limiting Toxicities (DLTs) During the Phase 1 Dose-Finding Phase |
0; 0; 11.1 | — |
| PRIMARY Percentage of Participants With Preliminary Satisfactory Response (Complete Response [CR], CR With Incomplete Count Recovery [CRi], Partial Response [PR], or Resistant Disease [RD]) Indicating Disease Stability After First Dose During Phase 1 Dose-Finding |
100; 91.7; 88.9 | — |
| PRIMARY Percentage of Participants With CR or CRi During Phase 2 |
68.6 | — |
| PRIMARY Percentage of Participants With CR, CRi or PR During the Phase 1 Expansion Phase |
46.2 | — |
| SECONDARY Percentage of Participants With CR, CRi or PR in Phase 2 |
74.3 | — |
| SECONDARY Number of Participants With Minimal Residual Disease (MRD) Negativity in Participants Achieving CR and CRi |
2; 8; 8; 5; 18; 41 | — |
| SECONDARY Percentage of Participants With CR or CRi by Cytogenetic Category |
86.7; 66.7; 56.3; 65.0; 75.0; 50 | — |
| SECONDARY Percentage of Participants Who Had a Post-Treatment Stem-Cell Transplant (SCT) |
0; 75.0; 44.4; 23.1; 22.9; 33.3 | — |
| SECONDARY Progression Free Survival (PFS) |
5.5; NA; 8.8; 1.9; 3.7; 3.9 | — |
| SECONDARY Duration of Remission (DoR1) for Participants Who Achieved CR or CRi |
4.7; NA; 10.8; 7.1; 3.8; 4.8 | — |
| SECONDARY Duration of Response (DoR) for Participants Who Achieved CR/CRi or PR |
20.50; NA; 46.93; 31.07; 16.57; 18.71 | — |
| SECONDARY Overall Survival (OS) |
9.2; NA; 16.5; 5.8; 6.4; 7.4 | — |
| SECONDARY Time to Remission for Participants Who Achieved CR or CRi |
39.0; 29.0; 38.0; 27.0; 25.5; 27.0 | — |
| SECONDARY Time to Response for Participants Who Achieved CR/CRi or PR |
39.0; 29.0; 27.0; 24.0; 23.0; 25.0 | — |
| SECONDARY Time to MRD Negativity for Participants Who Achieved CR or CRi |
98.5; 32.0; 30.0; 25.0; 25.5; 29.0 | — |
| SECONDARY Duration of Follow-Up |
24.0; 25.7; 24.1; 24.2; 24.1 | — |
| SECONDARY Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit |
NA; NA; NA; 93.7; NA; 93.7 | — |
| SECONDARY Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit |
99.6; 98.7; 98.4; 95.1; 99.2; 99.0 | — |
| SECONDARY Messenger Ribonucleic Acid (mRNA) Gene Expression |
0.00421; 0.00440; 0.00746; 0.00783; 0.01983; 0.02245 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with CD22-positive ALL with either refractory disease (i.e. disease progression or no response while receiving their most recent prior anti-cancer therapy), or relapsed disease (i.e. response to their most recent prior anti-cancer therapy with subsequent relapse). Subjects enrolled in the Phase 2 portion of the study must be due to receive salvage 2 or later therapy.
- Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.
- Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.
Exclusion Criteria
- Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.
- Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.
- Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).
Data sourced from ClinicalTrials.gov (NCT01363297). 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.