| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01829711 | Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia | PHASE3 | COMPLETED | 80 | — | — | Apr 29, 2013 | Apr 29, 2019 | Apr 8, 2020 | 34 | United States, Belgium +12 |
Durable CR was defined as overall response that meets blood, bone marrow and imaging criteria for CR, followed by a \>180 day duration of hematologic remission (HR). CR requires all of the following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (\>= 2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either \< 17 cm or have decreased by \>25% from its baseline.); HR requires normal complete blood count (CBC) as exhibited by: Neutrophils \>= 1.5 x 10\^9/L, Platelets \>= 100 x 10\^9/L, and hemoglobin \>= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.
Durable CR was defined as overall response that meets blood, bone marrow and imaging criteria for CR, followed by a \>180 day duration of HR. CR requires all of the following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (\>= 2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either \< 17 cm or have decreased by \>25% from its baseline.); HR requires normal complete blood count (CBC) as exhibited by: Neutrophils \>= 1.5 x 10\^9/L, Platelets \>= 100 x 10\^9/L, and hemoglobin \>= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.
| Arm | Type | Description |
|---|---|---|
| Moxetumomab pasudotox 40 µg/kg | EXPERIMENTAL | Patients will receive Moxetumomab Pasudotox intravenously (IV) over 30 minutes on days 1, 3, 5 of each 28 day cycle for a maximum of 6 cycles or until disease progression, unacceptable toxivity, initiation of alternate therapy or documented CR. |
| Name | Type | Description |
|---|---|---|
| Moxetumomab pasudotox | DRUG | - |
| IV Bag Protectant for Moxetumomab pasudotox | DRUG | - |
* INCLUSION CRITERIA: * Patients must have histologically confirmed hairy cell leukemia or hairy cell leukemia variant .with a need for therapy * Patients must be Pseudomonas-immunotoxin naive * Patients must have had at least 2 prior purine analogs, or at least 1 course of purine analog and 1 of ei...