Clinical trial · Interventional
E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
NCT01401530CI-TRIAL-00035919completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| denileukin diftitox (E7777) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- E7777
- interventionNames
- Biological: denileukin diftitox (E7777)
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
- timeFrame
- For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)
- description
- The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOhmachi K, Ando K, Ogura M, Uchida T, Tobinai K, Maruyama D, Namiki M, Nakanishi T. E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma: A phase I study. Cancer Sci. 2018 Mar;109(3):794-802. doi: 10.1111/cas.13513. Epub 2018 Feb 26. PMID 29363235