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CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia

About

Brief Summary

This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia that has come back after it was previously in remission. CPX-351 is a chemotherapy, which works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to chemotherapy called calicheamicin. Gemtuzumab attaches to CD33 (transmembrane receptor) positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving CPX-351 and gemtuzumab ozogamicin may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Bone marrow blasts >= 5% that develops after remission, no restriction on prior number of relapses or regimens
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • At least a 3-month duration of remission prior to relapse
  • Participants with relapse after allogeneic transplantation are included
  • Up to 1 cycle of hypomethylating agent monotherapy at time of relapse is allowed, must be discontinued at least 14 days prior to start of salvage induction
  • Serum total bilirubin =< 2.0 mg/dL, unless considered due to Gilbert?s disease or leukemia involvement
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 times the upper limit of normal, unless considered due to leukemia involvement
  • Alkaline phosphatase =< 3 times the upper limit of normal, unless considered due to leukemia involvement
  • Serum creatinine =< 2.0 mg/dL, or creatinine clearance > 40 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR)
  • Ability to give full informed consent on their own
  • Females of reproductive potential (postmenopausal for less than 24 consecutive months) must have a negative pregnancy

Exclusion Criteria:

  • Currently receiving targeted therapy for FLT3 (cytokine receptor tyrosine kinase class III), IDH1, or IDH2 (isocitrate dehydrogenase, 1, 2) mutations and intent to continue use; prior use of targeted therapy for such mutations is allowed, but agents should be discontinued 1 week prior to enrollment
  • Acute promyelocytic leukemia
  • Second malignancy that would limit survival by less than 2 years
  • New York Heart Association class III or VI
  • Left ventricular ejection fraction < 50%
  • History of coronary stent placement that requires mandatory continuation of dual-antiplatelet therapy
  • History of Wilson?s disease or other copper handling disorders
  • Hypersensitivity to cytarabine, daunorubicin, or liposomal products
  • Active invasive fungal infection
  • Active bacterial or viral infection manifesting as fevers or hemodynamic instability within the past 72 hours
  • Lifetime cumulative daunorubicin-equivalent anthracycline dose > 368 mg/m^2

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Study Stats
Protocol No.
18-001419
Category
Hematology-Oncology
Oncology
Contact
Caspian Oliai
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03904251
For detailed technical eligibility, visit ClinicalTrials.gov.