A Phase I Study of DT2219ARL (IND #100780), a Bispecific Chain Immunotoxin for the Treatment of CD19(+), CD22 (+) B-Lineage Leukemia or Lymphoma
- Determine the toxicities and maximum-tolerated dose of anti-CD19/CD22 bispecific
ligand-directed toxin DT2219ARL in patients with relapsed or refractory CD19+ and CD22+
B-lineage leukemia or lymphoma.
- Determine the pharmacokinetic profile (PK) (Cmax, T1/2, AUC, Cl, Vd) of DT2219ARL.
- Determine any therapeutic activity of DT2219ARL within the confines of a phase I study
as determined by the change in percentage of blasts in bone marrow and peripheral blood
and recovery of normal hematopoiesis.
- Measure levels of human anti-DT2219ARL antibodies.
- Determine if there is a correlation between PK parameters and toxicity or response.
- Determine if the expression of the CD19 and CD22 cell surface antigens is affected by
treatment with DT2219ARL using flow cytometric analysis of lymphoblasts in peripheral
blood and bone marrow or immunohistochemistry of node biopsies.
- Determine whether the CD19 and CD22 surface antigen expression on patient blasts or
lymphoma cells correlate with response.
OUTLINE: This is a multicenter study.
Patients receive anti-CD19/CD22 bispecific ligand-directed toxin DT2219ARL IV over 4 hours
on days 1, 3, 5, and 7 in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study for pharmacokinetic
and immunologic studies. Bone marrow aspirates are collected at baseline and day 28 for CD19
and CD22 antigens expression by flow cytometric assays or enzyme immunoassays.
After completion of study therapy, patients are followed periodically.
Primary Purpose: Treatment
Arthur E. Frankel, MD
Scott and White Hospital & Clinic
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Scott and White Cancer Institute||Temple, Texas 76508|