Phase 1
N=13
E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Peripheral T-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01401530 ↗Enrolled (actual)
13
Serious AEs
38.5%
Results posted
Nov 2018
Primary outcome: Primary: Maximum Tolerated Dose (MTD) and Recommended Dose (RD) — 9 ug/kg/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- denileukin diftitox (E7777) (Biological)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) and Recommended Dose (RD) |
9 | — |
| SECONDARY Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox |
3; 7; 3; 3; 7; 3 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Denileukin Diftitox |
129; 149; 181 | — |
| SECONDARY Time to Cmax (Tmax) of Denileukin Diftitox in Serum |
64.000; 64.000; 74.500 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t)) |
10300; 16900; 18600 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) |
16800; 25200; 35600 | — |
| SECONDARY Terminal Phase Rate Constant (λz) |
0.00746; 0.0103; 0.00793 | — |
| SECONDARY Terminal Elimination Phase Half-life (t1/2) |
92.9; 67.8; 87.4 | — |
| SECONDARY Volume of Distribution at Terminal Phase (Vz) |
54.2; 45.2; 49.5 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) |
59.8; 48.4; 54.1 | — |
| SECONDARY Total Clearance (CL) |
0.404; 0.361; 0.393 | — |
| SECONDARY Recommended Dose |
— | — |
Summary
The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.
Eligibility Criteria
lnclusion Criteria:
- Male and female patients 20 to less than 80 years of age at the time of informed consent
- Patients histologically or cytologically diagnosed to have peripheral T -cell lymphoma
- Patients with a history of chemotherapy (including PUVA and retinoid) that resulted in relapse, recurrence and treatment resistance (just for the administration of E7777 alone)
- Patients subject to CHOP therapy and without a history of prior treatment with anthracycline or anthraquinone anticancer drugs (just for the administration of E7777 in combination with CHOP therapy)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- No carry-over of beneficial or adverse effects of the prior treatment that may affect the safety evaluation of the investigational drug (excluding Grade 1 neuropathy and alopecia)
Exclusion Criteria
- Brain metastasis with clinical symptoms which requires treatment
- Serious systemic infection requiring intensive treatment
- Serious complications or histories
- History of hypersensitivity to protein therapeutics
- Known to be positive for HIV antibody, HCV antibody, or HBs antigen
- History of malignancy other than peripheral T-cell lymphoma and less than five years have elapsed since the last remission
- Patients who have undergone allogeneic hematopoietic stem cell transplantation
- Patients with a relapse within 6 months after autologous hematopoietic stem-cell transplantation
Data sourced from ClinicalTrials.gov (NCT01401530). 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.