Spots Global Cancer Trial Database for Phase I/II Study of hLL1-DOX in Relapsed NHL and CLL

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Trial Identification

Brief Title: Phase I/II Study of hLL1-DOX in Relapsed NHL and CLL

Official Title: A Phase I/II Study of Immunotherapy With hLL1-DOX in Patients With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Study ID: NCT01585688

Conditions

Non-Hodgkin's Lymphoma

Chronic Lymphocytic Leukemia

Interventions

hLL1-DOX (IMMU-115)

Study Description

Brief Summary: The primary objectives are to evaluate the safety and tolerability of hLL1-DOX, and to determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated dosing schedule). The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies.

Detailed Description: Patients receive hLL1-DOX at one of 4 dose levels administered on Days 1, 4, 8 and 11 of 21-day treatment cycles which are continued in the absence of progression or unacceptable toxicity up to a total of 8 cycles. After treatment, follow-up will be done at 4, 8 and 12 weeks post-treatment and will continue to be done every 3 months for up to 2 years.