Clinical trial · Interventional
DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
Therapy Targeting the Interleukin-3 Receptor (IL3R) for Patients With Relapsed or Refractory and Elderly or Poor-Risk Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome With DTIL3 (IND# 11314): a Phase I/II Clinical Trial
NCT00397579CI-TRIAL-00038297completedPhase 1 / Phase 2Results 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)
RATIONALE: Combinations of biological substances in DT388IL3 fusion protein may be able to carry cancer killing substances directly to the cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of DT388IL3 fusion protein and to see how well it works in treating patients with acute myeloid leukemia or myelodysplastic syndromes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blastic Plasmacytoid Dendritic Cell Neoplasm | Blastic Plasmacytoid Dendritic Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DT388IL3 | Drug | Tagraxofusp | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SL-401
- description
- Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily.
- interventionNames
- Drug: DT388IL3
Primary outcomes (1)
- measure
- Overall Response Rate (CR+PR+SD): Percentage of Participants Experiencing Response
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months
- description
- Patients will be treated with a maximum of five doses of approximately 15min IV infusions of DT388IL3/SL-401 over a ten day period at a maximum of once daily. Response to Treatment will be evaluated as follows: Complete response (CR): patient has a normal whole blood count; platelets with absent blasts in peripheral blood or marrow; no evidence of nodal involvement or liver/spleen involvement; no skin lesion involvement. Partial Response (PR); patient experiences a decrease of 50% or more in marrow blasts and skin lesions; and there is a decrease in the size of the nodes/liver/spleen. Stable Disease (SD); failure to achieve at least PR, and there is no evidence of progression for 2 months. Failure: death during treatment or disease progression characterized by an increase in the percentage bone marrow blast or an increase in skin or node/liver or spleen size. Reported is the percentage of participants experiencing either CR, PR or SD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Histologically or morphologically confirmed acute myeloid leukemia (AML), meeting 1 of the following criteria:
* Relapsed or refractory AML after treatment with ≥ 1 prior conventional induction therapy
* Patients in early first relapse must not have a matched donor available and/or be ineligible for allogeneic stem cell transplantation
* Poor-risk AML, as defined by any of the following criteria:
* Treatment-related AML, unless associated with favorable cytogenetics (e.g., inversion 16, t\[16;16\], t\[8;21\], t\[15;17\]), and ineligible for stem cell transplantation
* Antecedent hematological disease (e.g., myelodysplastic syndromes, myelofibrosis, or polycythemia vera) that evolved to AML (≥ 20% blasts) and ineligible for stem cell transplantation
* De novo AML (must be \> 70 years of age)
* AML with unfavorable cytogenetics (e.g., abnormalities of chromosomes -7, -5, 7q-, or 5q-; complex \[≥ 3\] abnormalities; or abnormalities of 11q23, excluding t\[9;11\], t\[9;22\], inversion 3, t\[3;3\], and t\[6;9\]), regardless of age, and ineligible for allogeneic stem cell transplantation
* High-risk myelodysplastic syndromes diagnosed by morphologic, histochemical, or cell surface marker criteria
* Resistant or intolerant to chemotherapy
* Ineligible for or unwilling to undergo immediate allogeneic stem cell transplantation
* Bone marrow index (i.e., percent cellularity × percent blasts) ≤ 40% at time of treatment
* No active CNS leukemia
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Bilirubin ≤ 1.5 mg/dL
* ALT and AST \< 2.5 times upper limit of normal
* Albumin ≥ 3 mg/dL
* Creatinine ≤ 1.5 mg/dL
* LVEF ≥ 50%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 weeks after completion of study treatment
* No complicated medical or psychiatric problems that would preclude study compliance
* No concurrent serious uncontrolled infection or disseminated intravascular coagulation
* No myocardial infarction within the past 6 months
* No allergies to diphtheria toxin
* No requirement for oxygen
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No other concurrent antineoplastic drugs
* No concurrent radiotherapy
* No concurrent corticosteroids as antiemetics
* No concurrent hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim \[G-CSF\], or sargramostim \[GM-CSF\])
* No concurrent intravenous immunoglobinsReferences
Publications (1)
- DERIVEDFrankel AE, Woo JH, Ahn C, Pemmaraju N, Medeiros BC, Carraway HE, Frankfurt O, Forman SJ, Yang XA, Konopleva M, Garnache-Ottou F, Angelot-Delettre F, Brooks C, Szarek M, Rowinsky E. Activity of SL-401, a targeted therapy directed to interleukin-3 receptor, in blastic plasmacytoid dendritic cell neoplasm patients. Blood. 2014 Jul 17;124(3):385-92. doi: 10.1182/blood-2014-04-566737. Epub 2014 May 23. PMID 24859366