Status:
COMPLETED
DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of DT\_388IL3 fusion protein in patients with refractory or relapsed or poor-risk acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00397579
Start Date
May 1 2013
End Date
July 27 2017
Last Update
April 23 2019
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390