Conditions

Leukemia Myelodysplastic Syndromes Blastic Plasmacytoid Dendritic Cell Neoplasm

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)recurrent adult acute myeloid leukemiasecondary acute myeloid leukemiauntreated adult acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesblastic plasmacytoid dendritic cell neoplasmplasmacytoid dendritic cell leukemiaCD123+

Outcome Measures

Primary Outcomes (1)

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.
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

Study Arms (1)

SL-401

EXPERIMENTAL

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

Interventions

DT388IL3Drug

Intravenously via a 3 cc plastic syringe as a 15 minute bolus infusion daily for five days.

SL-401

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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 immunoglobins

Sponsors & Collaborators

University of Texas Southwestern Medical Center
Otherlead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Related Publications (1)

Frankel 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: 24859366DERIVED

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesBlastic Plasmacytoid Dendritic Cell NeoplasmCongenital AbnormalitiesLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesHistiocytic Disorders, MalignantLymphomaHematologic NeoplasmsNeoplasms by SiteSkin Neoplasms

Results Point of Contact

Title: Clinical Research Office
Organization: University of Texas Southwestern Medical Center at Dallas

Study Officials

Arthur E. Frankel, MD
University of Texas Southwestern Medical Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

SL-401

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

SL-401

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations