Table 2.
Clinical trials of drug-conjugated anti-CD33 mAbs other than GO.
| Disease type and inclusion criteria | Drug or drug combination, other therapies | Outcome measures | (Estimated) enrollment | Clinical trials identifier | Trial status |
|---|---|---|---|---|---|
| R/R AML High-risk MDS CML |
Lintuzumab-90Y | Primary: toxicity, MTD, and ORR | 24 | NCT00002890 | Completed (2001) |
| AML, ALL High-risk MDS |
Lintuzumab-90Y + etoposide + aHSCT | Primary: MTD, toxicity and engraftment efficacy | 24 | NCT00006040 | Completed (2003) |
| R/R AML AML in patients not eligible for curative therapy ap or bc CML high-risk MDS MDS/MPN (CMML) |
Lintuzumab-213Bi + cytarabine | Primary: MTD | 32 | NCT00014495 | Completed (2009) |
| R/R AML ap or bc CML High-risk MDS |
Lintuzumab-225Ac | Primary: MTD | 23 | NCT00672165 | Completed (2015) |
| De novo AML in patients ≥60 years | Lintuzumab-225Ac + low-dose cytarabine | Primary: MTD Secondary: toxicity PFS, DFS, and OS |
72 | NCT02575963 | Recruiting (estimated completion early 2019) |
| Relapsed AML AML in patients not eligible for curative therapy |
Vadastuximab talirine (SGN-CD33A) + AZA or decitabine vs. vadastuximab talirine (SGN-CD33A) monotherapy | Primary: AE and LA Secondary: PK, ADA, CR, DOR, RFS, and OS |
195 | NCT01902329 | Completed late 2017 |
| De novo AML | Vadastuximab talirine (SGN-CD33A) during induction with cytarabine and daunorubicin; during consolidation with high-dose cytarabine; as a monotherapy for maintenance | Primary: AE, DLT, and LA Secondary: CR, DFS, OS, PK, ADA, and MRD |
116 | NCT02326584 | Active, not recruiting (estimated completion late 2021) |
| De novo or secondary AML, intermediate or adverse-risk cytogenetics | Vadastuximab talirine (SGN-CD33A) + AZA or decitabine vs. placebo + AZA or decitabine | Primary: OS and CR Secondary: toxicity, MRD level, and EFS |
240 | NCT02785900 | Terminated June 2016 due to higher rate of deaths and infections in verum group |
| High-risk MDS | Vadastuximab talirine (SGN-CD33A) + AZA vs. placebo + AZA | Primary: toxicity and ORR Secondary: toxicity, CR, HI, DOR, PFS, rate of transformation to AML, and OS |
19 (142 planned) | NCT02706899 | Terminated late 2017 due to results from NCT02785900 |
| R/R AML | Vadastuximab talirine (SGN-CD33A) + melphalan + fludarabine, followed by aHSCT Vadastuximab talirine (SGN-CD33A) monotherapy after aHSCT |
Primary: AE, 1-year-survival, MRD level Secondary: DOR and OS |
14 | NCT02614560 | Terminated late 2017 due to results from NCT02785900 |
| R/R AML in patients not eligible for curative therapy | Monotherapy with IMGN779 (anti-CD33 mAb indolino benzodiazepine ADC) | Primary: MTD Secondary: AE, ORR, PK, and ADA |
124 | NCT02674763 | Recruiting (estimated completion early 2019) |
ADA, anti-drug antibodies; ADC, antibody–drug conjugate; AE, adverse events; aHSCT, allogeneic hematopoietic stem cell transplantation; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; ap, accelerated-phase; AZA, 5-azacytidine; bc, blast-crisis; CML, chronic myeloid leukemia; CMML, chronic myelomonocytic leukemia; CR, complete remission; DFS, disease-free survival; DLT, dose-limiting toxicity; DOR, duration of response; GO, gemtuzumab ozogamicin; HI, hematological improvement; LA, laboratory abnormalities; mAb, monoclonal antibody; MDS, myelodysplastic syndrome; MDS/MPN, myelodysplastic-myeloproliferative neoplasm; MRD, minimal residual disease; MTD, maximum tolerated dose; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; R/R, refractory/relapsed.
Data from http://ClinicalTrials.gov (Accessed: February 20, 2018).