Lymphoma Clinical Trial
Official title:
A Phase I Study of DT2219ARL, A Bispecific Singe Chain Immunotoxin for the Treatment of Relapsed or Refractory CD19(+), CD22(+) B-Lineage Leukemia or Lymphoma
This is a phase I dose escalation study of DT2219ARL for the treatment of relapsed or
refractory B-lineage leukemia and lymphoma. Patients will receive a single course of
DT2219ARL as a 4 hour infusion on days 1, 3, 5, and 8. Weekly follow-up will continue through
day 29, at which time a disease reassessment will be done. For patients in remission,
follow-up will continue monthly until disease progression or start of a new treatment.
Otherwise day 29 will be the final study visit if there is no ongoing toxicity.
This phase I study will use Continual Reassessment Method (CRM) to establish a maximum
tolerated dose (MTD) of DT2219ARL. Up to 3 dose levels will be tested with an additional dose
level (-1) if dose level 1 proves too toxic. The goal of CRM is to identify the dose level
which correspondences to a desired toxicity rate of 33% or less using grade 3 or 4 capillary
leak syndrome and any grade 3 or greater toxicity attributed to DT2219ARL as the targeted
toxicity (based on CTCAE version 4).
The current study was initially conducted at University of Texas and the Scott and White
Cancer Institute (A. Frankel, MD - PI) and M. D. Anderson Cancer Center with 15 evaluable
patients enrolled by the end of 2011 (table 1). The 3rd patient enrolled in the 40 μg/kg dose
cohort was the first to experience dose limiting toxicity (grade 3 neurological: lower
extremity weakness) receiving only 3 of the 4 planned doses. Per study design, the 40 μg/kg
would enroll an additional 3 patients to confirm dose limiting toxicity. It is at this point
the Texas centers discontinued involvement in the study.
Approximately 15 months after the last patient was enrolled under the original study plan,
the protocol was redesigned by the Masonic Cancer Center at the University of Minnesota,
building on the experience of the 1st 15 patients enrolled through the Texas centers. To
increase efficiency, the study design was changed from the standard 3 x 3 dose escalation to
a Continuous Reassessment Method (CRM) model testing 3 doses levels (40, 60, and 80 ug/kg)
with an added feature of a dose level -1 (30 ug/kg) in the event dose level 1 proves too
toxic. The maximum tolerated dose will be identified once 20 evaluable patients are enrolled.
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