Denileukin Diftitox
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Also known as DAB(SUB 389)IL2DAB-389IL2DAB389 IL2DAB389IL2DenileukinDenileukin diftitox-cxdlDenileukina diftitoxDenileukine diftitoxE-7272E-7777E7272E7777LY-335348LY335348LymphirOntakDENILEUKINE-DIFITOX
Summary
Denileukin Diftitox (CHEMBL1201550) is an approved protein (ATC L01XX29); indicated across 23 conditions including neoplasm and primary cutaneous t-cell non-hodgkin lymphoma.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Protein
- ATC class: L01XX29
- Indications: 23 conditions
- Clinical trials: 37
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201550 |
| Name | Denileukin Diftitox |
| Type | Protein |
| Max phase | 4 |
| ATC | L01XX29 |
Also known as: DAB(SUB 389)IL2, DAB-389IL2, DAB389 IL2, DAB389IL2, Denileukin, Denileukin diftitox, Denileukin diftitox-cxdl, Denileukina diftitox, Denileukine diftitox, E-7272, E-7777, E7272
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
23 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| primary cutaneous T-cell non-Hodgkin lymphoma | 4 | MONDO:0000607 | EFO:0002913 |
| lymphoma | 3 | MONDO:0005062 | EFO:0000574 |
| peripheral T-cell lymphoma, not otherwise specified | 3 | MONDO:0004964 | EFO:0000211 |
| melanoma | 2 | MONDO:0005105 | EFO:0000756 |
| exocrine pancreatic carcinoma | 2 | MONDO:0005192 | EFO:0002618 |
| T-cell acute lymphoblastic leukemia | 2 | MONDO:0004963 | EFO:0000209 |
| B-cell chronic lymphocytic leukemia | 2 | MONDO:0004948 | EFO:0000095 |
| acute myeloid leukemia | 2 | MONDO:0018874 | EFO:0000222 |
| leukemia | 2 | MONDO:0005059 | EFO:0000565 |
| non-Hodgkin lymphoma | 2 | MONDO:0018908 | EFO:0005952 |
| fallopian tube carcinoma | 2 | MONDO:0006206 | EFO:1000251 |
| peritoneal neoplasm | 2 | MONDO:0006901 | MONDO:0002087 |
| fallopian tube neoplasm | 2 | MONDO:0021092 | MONDO:0002158 |
| ovarian cancer | 2 | MONDO:0008170 | MONDO:0008170 |
| graft versus host disease | 2 | MONDO:0013730 | MONDO:0013730 |
| cutaneous melanoma | 2 | MONDO:0005012 | EFO:0000389 |
| ovarian carcinoma | 2 | MONDO:0005140 | EFO:0001075 |
| plasma cell myeloma | 1 | MONDO:0009693 | EFO:0001378 |
| male breast carcinoma | 1 | MONDO:0005628 | EFO:0006861 |
| endometrioid adenocarcinoma | 1 | MONDO:0005026 | EFO:0000466 |
| ovarian serous cystadenocarcinoma | 1 | MONDO:0006046 | EFO:1000043 |
| kidney cancer | 0 | MONDO:0002367 | MONDO:0002367 |
Clinical trials
Total trials: 37.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 22 |
| PHASE1 | 5 |
| PHASE1/PHASE2 | 4 |
| PHASE4 | 2 |
| PHASE3 | 2 |
| EARLY_PHASE1 | 1 |
| Not specified | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00050999 | PHASE4 | COMPLETED | Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients |
| NCT00051012 | PHASE4 | COMPLETED | Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients |
| NCT01355783 | PHASE3 | WITHDRAWN | A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell Lymphoma |
| NCT01871727 | PHASE3 | COMPLETED | A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma |
| NCT05200559 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors |
| NCT00003615 | PHASE2 | COMPLETED | Denileukin Diftitox in Treating Patients With Non-Hodgkin’s Lymphoma |
| NCT00006345 | PHASE2 | COMPLETED | Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma |
| NCT00026429 | PHASE2 | UNKNOWN | Denileukin Diftitox in Treating Patients With Non-Hodgkin’s Lymphoma |
| NCT00051025 | PHASE2 | COMPLETED | Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin’s Lymphoma (NHL) |
| NCT00055146 | PHASE2 | COMPLETED | Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) |
| NCT00082914 | PHASE2 | COMPLETED | Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer |
| NCT00082940 | PHASE2 | COMPLETED | Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia |
| NCT00138164 | PHASE2 | COMPLETED | Denileukin Diftitox in Treating Patients With Relapsed or Refractory Non-Hodgkin’s Lymphoma |
| NCT00211185 | PHASE2 | COMPLETED | A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma |
| NCT00224874 | PHASE2 | COMPLETED | Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302) |
| NCT00299689 | PHASE2 | COMPLETED | Phase II Trial of Ontak With Metastatic Melanoma |
| NCT00337987 | PHASE2 | COMPLETED | A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma |
| NCT00425672 | PHASE1/PHASE2 | COMPLETED | ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment |
| NCT00460109 | PHASE2 | COMPLETED | Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin’s Lymphoma |
| NCT00515528 | PHASE2 | TERMINATED | Vaccination Plus Ontak in Patients With Metastatic Melanoma |
| NCT00632827 | PHASE2 | TERMINATED | Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak) |
| NCT00726037 | PHASE2 | TERMINATED | A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer |
| NCT00801918 | PHASE2 | WITHDRAWN | Denileukine Diftitox for Relapsed ALCL |
| NCT00880360 | PHASE2 | COMPLETED | A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer |
| NCT00945269 | PHASE1/PHASE2 | TERMINATED | Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma |
| NCT01106950 | PHASE2 | TERMINATED | Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML) |
| NCT01127451 | PHASE2 | COMPLETED | Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma |
| NCT01773889 | PHASE2 | TERMINATED | A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer |
| NCT02676778 | PHASE2 | COMPLETED | Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma |
| NCT04855253 | PHASE1/PHASE2 | SUSPENDED | Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL |
| NCT00128622 | PHASE1 | COMPLETED | Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer |
| NCT00224354 | PHASE1 | WITHDRAWN | Lymphocytic B-Leukemia (B-CLL) w/Human IL-2 Gene Modified & Human CD40 Ligand-Expressing Autologous Tumor Cells |
| NCT00228358 | PHASE1 | COMPLETED | Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient’s Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine |
| NCT00357448 | PHASE1 | COMPLETED | Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer |
| NCT01401530 | PHASE1 | COMPLETED | E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma |
| NCT00278369 | EARLY_PHASE1 | COMPLETED | Pilot Study of Denileukin Diftitox Plus High-Dose IL-2 for Patients With Metastatic Renal Cancer |
| NCT00513188 | Not specified | WITHDRAWN | Combination Chemotherapy and Denileukin Diftitox in Treating Patients With Newly Diagnosed T-Cell Non-Hodgkin Lymphoma |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).