Phase 1 N=49 Treatment

A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia

Hairy Cell Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00586924 ↗

Enrolled (actual)

Serious AEs

12.2%

Results posted

Apr 2019

Primary outcome: Primary: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Moxetumomab Pasudotox (CAT 8015) (Drug); CAT 8015 (Moxetumomab Pasudotox) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MedImmune LLC
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs)	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	3; 3; 3; 3; 4; 33	—
PRIMARY Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)	1; 1; 2; 3; 1; 16	—
PRIMARY Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)	1; 0; 0; 2; 0; 2	—
PRIMARY Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)	1; 1; 1; 3; 2; 25	—
PRIMARY Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)	3; 3; 2; 2; 3; 29	—
PRIMARY Number of Participants With Complete Response (CR)	0; 2; 2; 1; 2; 21	—
PRIMARY Number of Participants With Partial Response (PR)	3; 1; 0; 1; 1; 8	—
PRIMARY Number of Participants With Stable Disease (SD)	0; 0; 1; 1; 0; 4	—
PRIMARY Number of Participants With Progressive Disease (PD)	0; 0; 0; 0; 1; 0	—
PRIMARY Time to Complete Response	2.53; 9.56; 3.71; 2.53; 3.94	—
PRIMARY Time to Objective Response	3.02; 1.12; 8.2; 8.18; 1.08; 1.05	—
PRIMARY Duration of Complete Response	NA; 25.89; 70.34; 42.35	—
PRIMARY Duration of Objective Response	8.34; 84.44; 80.95; 78.29; NA	—
PRIMARY Time to Progression	11.33; NA; NA; 82.07; NA; NA	—
PRIMARY Progression-free Survival (PFS)	11.33; NA; NA; 82.07; NA; NA	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox for Cycle 1 on Day 1	0.508; 0.467; 0.367; 0.467; 0.267; 0.417	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox for Cycle 1 on Day 5	0.500; 0.467; 0.250; 0.517; 0.475; 0.417	—
PRIMARY Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox for Cycle 1 on Day 1	77.5; 86.3; 49.4; 443; 290; 435	—
PRIMARY Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox for Cycle 1 on Day 5	103; 135; 161; 420; 701; 738	—
PRIMARY Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) of Moxetumomab Pasudotox for Cycle 1 on Day 1	113; 31.0; 109; 897; 183; 558	—
PRIMARY Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) of Moxetumomab Pasudotox for Cycle 1 on Day 5	179; 90.2; 93.2; 1360; 1640; 1920	—
PRIMARY Systemic Clearance (CL) of Moxetumomab Pasudotox for Cycle 1 on Day 1	32.6; 49.1; 43.9; 91.8; 106	—
PRIMARY Systemic Clearance (CL) of Moxetumomab Pasudotox for Cycle 1 on Day 5	13.3; 68.9; 66.3; 18.7; 45.5; 33.3	—
PRIMARY Terminal Phase Elimination Half Life (t1/2) of Moxetumomab Pasudotox for Cycle 1 on Day 1	0.643; 3.77; 1.00; 0.375; 0.799	—
PRIMARY Terminal Phase Elimination Half Life (t1/2) of Moxetumomab Pasudotox for Cycle 1 on Day 5	2.20; 0.369; 0.404; 1.86; 1.66; 2.06	—
PRIMARY AUC Accumulation Ratio of Moxetumomab Pasudotox for Cycle 1	2.62; 3.08; 3.09; 1.93; 12.4; 3.63	—
PRIMARY Cmax Accumulation Ratio of Moxetumomab Pasudotox for Cycle 1	1.11; 1.73; 2.12; 1.48; 2.51; 1.58	—
SECONDARY Number of Participants With Positive Neutralizing Antibodies and Correlation to Antitumor Activity	2; 2; 2; 1; 0; 7	—
SECONDARY CD22 Expression Levels From Peripheral Blood by Best Response	65434.0; 72632.0; 43803.0; 61773.0; 68141.3; 38402.7	—
SECONDARY CD22 Expression Levels From Bone Marrow by Best Response	75157.0; 50190.0; 55850.5; 36286.0; 37732.5; 80400.0	—
SECONDARY Soluble CD22 Levels by Best Response	2583.0; 60021.0; 5109.0; 10232.0; 22202.9; 3016.3	—

Summary

A dose-escalation study to identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), defined as the highest dose that can safely be given to a participant and establish the safest dose based on the highest tolerated dose for clinical testing.

Eligibility Criteria

Inclusion Criteria: Confirmed diagnosis of HCL, Measurable disease, Participant's must have had at least 2 prior systemic therapies. There must have been at least 2 prior courses of purine analog, or 1 if the response to this course lasted less than ( =) Grade 2, unless bilirubin is due to Gilbert's disease. -Renal function: Serum creatinine clearance less than or equal to (<=) 60 millilitre per minute (mL/min) as estimated by Cockroft-Gault formula. -Hematologic function: The absolute neutrophil count (ANC) < 1000/ cubic millimetres (cmm), or platelet count <50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy). -Pulmonary function: Participant's with < 50% of predicted forced expiratory volume (FEV1) or <50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Uncontrolled pulmonary infection, presence of pulmonary edema, Oxygen saturation at rest < 88% measured by pulse oximetry or partial pressure of oxygen (PaO2) < 55 millimetre(s) of mercury (mm Hg), Serum albumin < 2 g/dL, Radioimmunotherapy within 2 years prior to enrollment in study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00586924). 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.