A Phase 1/2 interventional study of DT388IL3 in Leukemia, Myelodysplastic Syndromes and Blastic Plasmacytoid Dendritic Cell Neoplasm, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by University of Texas Southwestern Medical Center · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a phase I, multicenter, dose-escalation study followed by a phase II, open-label study.
Cohorts of 3-6 patients receive escalating doses of DT_388IL3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 11 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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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
Poor-risk AML, as defined by any of the following criteria:
High-risk myelodysplastic syndromes diagnosed by morphologic, histochemical, or cell surface marker criteria
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
Drug: DT388IL3
Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days.
Overall Response Rate (CR+PR+SD): Percentage of Participants Experiencing Response
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.
Time frame: 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
| Milestone | SL-401 |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
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.
| percentage of participants | SL-401 |
|---|---|
| Overall Response Rate (CR+PR+SD): Percentage of Participants Experiencing Response | 81.8 |
Collected over 10 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SL-401 | 0/11 (0%) | 0/11 (0%) | 11/11 (100%) |
| Event | SL-401 |
|---|---|
| ASTHepatobiliary disorders | 4/11 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/11 |
| ALTHepatobiliary disorders | 3/11 |
| NeutropeniaBlood and lymphatic system disorders | 1/11 |
| HyponatremiaBlood and lymphatic system disorders | 1/11 |
Patients with BPDCN treated with SL-401.
| Age, Categorical(Participants) | SL-401 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 10 |
| Age, Continuous(years) | SL-401 |
|---|---|
| Mean | 68 (40 to 77) |
| Sex: Female, Male(Participants) | SL-401 |
|---|---|
| Female | 0 |
| Male | 11 |
| Race (NIH/OMB)(Participants) | SL-401 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | SL-401 |
|---|---|
| United States | 11 |
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University of Texas Southwestern Medical Center