Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

Genzyme

Status and phase

Terminated

Phase 1

Conditions

Hematologic Malignancies

Treatments

Drug: CAMPATH (alemtuzumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00113048

CAM111

Details and patient eligibility

About

This phase I study will involve escalating doses of CAMPATH until the goal dose for the cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously (SQ) 3 times per week for up to 12 weeks.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with relapsed or refractory hematologic malignancy. The anticipated patient population are patients with chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma or myeloma
Patients with a history of a hematologic malignancy that has previously been shown by flow cytometry or immunophenotyping analysis to express CD52
Any chemotherapy, major surgery or irradiation must have been completed at least four (4) weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea)
Patients have recovered from the acute side effects due to prior therapy
Life expectancy of > 3 months
World Health Organization (WHO) Performance Status 0-2
18 years of age or older
Adequate organ function as defined in the protocol

Exclusion criteria

Prior therapy with CAMPATH
Use of an investigational agent within two (2) weeks prior to study enrollment
History of anaphylaxis following exposure to humanized monoclonal antibodies
Known human immunodeficiency virus (HIV) positive
Prior autologous bone marrow or stem cell transplant if within six (6) months of study entry
A history or prior allogenic bone marrow transplant or organ transplant
Known, symptomatic central nervous system (CNS) involvement with lymphoma
Pregnant or lactating women
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding skin infection, lower urinary tract infection, or oral infection), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements