Know Cancer

or
forgot password

Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Thank you

Trial Information

Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies


Inclusion Criteria:



- Histologically confirmed diagnosis of recurrent B cell non-Hodgkin's lymphoma or
diagnosis of recurrent chronic lymphocytic leukemia

- Patient has received at least one prior treatment with standard chemotherapy and at
least one prior treatment with rituximab (negative HAHA test required if received
prior humanized antibody treatment)

- Patient has not received anti-cancer therapy within 28 days of treatment unless
disease progression has been demonstrated and toxicities from prior therapy have
resolved

- Available tumor tissue (lymph node/mass, blood or bone marrow) for correlative
analyses (paraffin or frozen, recent or archived)

- Measurable disease as defined by a tumor mass > 1.5 cm in one dimension or WBC >
5,000 (CLL patients)

- Age > 18 years

- Patient has KPS > 50%

- Absolute granulocyte count > 1000 cells/mm3

- Platelet count > 50,000 cells/mm3

- Creatinine < 2.0 x ULN

- Total bilirubin < 2.0 x ULN

- Patient agrees to use birth control if of reproductive potential

- Patient has signed IRB-approved informed consent

Exclusion Criteria:

- Known central nervous system (CNS) involvement by lymphoma

- Known HIV disease

- Patient is pregnant or nursing

- Patient is receiving other investigational drugs

- Known serum human anti-human antibodies (HAHA)

- Estimated life expectancy of < 3 months

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the toxicity profile and maximum tolerated dose (MTD) of hLL1 when administered to patients with recurrent non-Hodgkin's lymphoma and chronic lymphocytic leukemia

Outcome Time Frame:

duration of study

Safety Issue:

Yes

Principal Investigator

John P Leonard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

0608008669

NCT ID:

NCT00504972

Start Date:

June 2007

Completion Date:

June 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Weill Cornell Medical CollegeNew York, New York  10021