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This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.
The study will be conducted in the following distinct parts:
Part A: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 and Day 4 dosing)
Part B: Consolidation dose escalation - consolidation combined with SGN-CD33A; up to 4 cycles of consolidation therapy will be administered after SGN-CD33A (Day 1 of each cycle).
Part C: Maintenance - SGN-CD33A Monotherapy; Up to 24 patients with and up to 24 patient without prior allogeneic stem cell transplant will be treated with SGN-CD33A. Both arms will enroll simultaneously. SGN-CD33A will be administered on Day 1 of each 6-week cycle for up to 8 cycles.
Part D: Induction plus consolidation - induction/consolidation combined with SGN-CD33A; patients who achieve a CR/CRi (with or without a second induction) will receive up to 4 cycles of consolidation therapy administered after SGN-CD33A (Day 1 of each cycle).
Part E: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 dosing)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction with SGN-CD33A | Experimental | 7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A |
|
| Consolidation with SGN-CD33A | Experimental | High dose cytarabine for consolidation + SGN-CD33A (28-day cycles) |
|
| SGN-CD33A Maintenance | Experimental | SGN-CD33A Monotherapy (42-day cycles) |
|
| Induction and Consolidation with SGN-CD33A | Experimental | 7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dose cytarabine for induction | Drug | 100 mg/m2/day Days 1-7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Through 1 month following last dose | |
| Incidence of laboratory abnormalities | Through 1 month following last dose | |
| Incidence of dose-limiting toxicity (DLT) | Through 1 month following last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission (CR) rate at the end of induction | Through 1 month following last dose | |
| Leukemia-free survival | Up to approximately 3 years | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Feldman, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| City of Hope National Medical Center |
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| SGN-CD33A | Drug | Given intravenously Day 1 or Days 1 and 4 of each cycle |
|
|
| Daunorubicin | Drug | 60 mg/m2/day Days 1-3 |
|
| High dose cytarabine for consolidation | Drug | 3g/m2 on Days 1, 3, and 5 of each cycle |
|
| Up to approximately 3 years |
| Blood concentrations of SGN-CD33A and metabolites | Up to approximately 3 years |
| Incidence of antitherapeutic antibodies (ATA) | Up to approximately 3 years |
| Rate of minimal residual disease (MRD) clearance | Up to approximately 3 years |
| Duarte |
| California |
| 91010-3000 |
| United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Cardinal Bernardin Cancer Center / Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Cleveland Clinic, The | Cleveland | Ohio | 44195 | United States |
| James Cancer Hospital / Ohio State University | Columbus | Ohio | 43210 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 30384 | United States |
| Charles A. Sammons Cancer Center / Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4095 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D020360 | Neoadjuvant Therapy |
| C000631166 | vadastuximab talirine |
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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