DT2219ARL Immunotoxin in Treating Patients With B-Cell Leukemia or Lymphoma That Has Relapsed or Not Responded to Treatment
Recruitment status was Recruiting
RATIONALE: Immunotoxins, such as DT2219ARL, can find certain cancer cells and kill them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of DT2219ARL immunotoxin in treating patients with B-cell leukemia or lymphoma that has relapsed or not responded to treatment.
Biological: anti-CD19/CD22 bispecific ligand-directed toxin DT2219ARL
Other: flow cytometry
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: pharmacological study
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of DT2219ARL (IND #100780), a Bispecific Chain Immunotoxin for the Treatment of CD19(+), CD22 (+) B-Lineage Leukemia or Lymphoma|
- Dose-limiting toxicity [ Designated as safety issue: Yes ]
- Toxicity profile [ Designated as safety issue: Yes ]
- Maximum-tolerated dose [ Designated as safety issue: Yes ]
- Clinical response rate (complete response [CR], partial response, marrow CR) [ Designated as safety issue: No ]
- Anti-DT2219ARL antibodies at days 1, 7, 15, and 30 [ Designated as safety issue: No ]
- Serum DT2219ARL levels and half-life [ Designated as safety issue: No ]
- Pre-treatment leukemic blast and lymphoma cell CD19 and CD22 densities [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
- 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.
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas||Recruiting|
|Houston, Texas, United States, 77030-4009|
|Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245|
|Scott and White Cancer Institute||Recruiting|
|Temple, Texas, United States, 76508|
|Contact: Clinical Trials Office - Scott and White Cancer Institute 800-882-4366|
|Principal Investigator:||Arthur E. Frankel, MD||Scott and White Hospital & Clinic|