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A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia

Phase 2
18 Years
Not Enrolling
B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Thank you

Trial Information

A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia

Inclusion Criteria:

- A diagnosis of B-cell chronic lymphocytic leukemia (B-CLL); according to the National
Cancer Institute Working Group (NCI WG) Criteria.

- World Health Organization (WHO) performance status of 0, 1, or 2.

- Life expectancy ≥ 12 weeks.

- Previous therapy with at least one but no more than 5 regimens (single agent or
combination regimen). One therapy regimen is defined as consecutive, contiguous
cycles of the same drug(s) with no treatment interruptions lasting > 3 months.

- Patient requires treatment for CLL per the following criteria: -Rai stage III or IV;
-Rai stage 0-II with at least one of the following - evidence of progressive marrow
failure as manifested by the development of, or worsening of, anemia and/or
thrombocytopenia; Massive (i.e. greater than 6 cm below the left costal margin) or
progressive splenomegaly; Progressive lymphocytosis with an increase of greater than
50% over a 2-month period or an anticipated doubling time of less than 6 months;
Lymphocyte count > 100*10^9/L; B symptoms.

- More than 3 weeks since prior chemotherapy. Patient must have recovered from the
acute side effects incurred as a result of previous therapy.

- More than 3 weeks since using investigational agents. Patient must have recovered
from the acute side effects incurred as a result of previous therapy.

- Serum creatinine and conjugated (direct) bilirubin less than or equal to 2 times the
institutional upper limit of normal (ULN) unless secondary to direct infiltration of
the liver with CLL.

- Female patients with childbearing potential must have a negative pregnancy test
(serum or urine) within 2 weeks of first dose of study drug(s). All patients must
agree to use an effective contraceptive method while on study treatment, if
appropriate, and for a minimum of 6 months following study therapy.

- Signed, written informed consent (in the US, includes The Health Insurance
Portability and Accountability Act of 1996 (HIPAA) authorization)

Exclusion Criteria:

- Positive Coombs test and evidence of active hemolysis.

- Platelet count less than 50*10^9/L without splenomegaly.

- History of anaphylaxis following exposure to rat or mouse derived CDR-grafted
humanized monoclonal antibodies.

- Previously treated with CAMPATH.

- Previous bone marrow transplant.

- Known central nervous system (CNS) involvement with B-CLL

- Active infection, including human immunodeficiency virus (HIV) positive.

- Active second malignancy.

- Recent documented history (within 2 years) of active tuberculosis (TB), current
active TB infection, currently receiving anti-tuberculous medication (e.g., INH,
rifampin, streptomycin, pyrazinamide, or others).

- Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive
hepatitis B serologies. Patients with a positive hepatitis B surface antibody
(HBsAb) test with a documented history of prior hepatitis B immunization are eligible
as long as other criteria are met (i.e. negative tests for: hepatitis B surface
antigen (HBsAg), hepatitis B core antibody (HBcAb) and hepatitis C virus antibody

- Other severe, concurrent diseases (e.g., cardiac or pulmonary disease), mental
disorders, or major organ malfunction (liver, kidney) that could interfere with the
patient ability to participate in the study.

- Pregnant or nursing women.

- Cytomegalovirus (CMV) positive by polymerase chain reaction (PCR) (above the level of
detection). A patient that is PCR positive will require treatment to reduce the
viral load to a non-detectable level; but such a patient may be considered for study
entry once the infection has been treated.

- Medical condition requiring chronic use of oral corticosteroids at a dose higher than
physiologic replacement.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)

Outcome Description:

Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.

Outcome Time Frame:

up to 44 weeks

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

August 2011

Related Keywords:

  • B-Cell Chronic Lymphocytic Leukemia (B-CLL)
  • Alemtuzumab
  • Leukemia
  • MabCampath
  • Chronic
  • Subcutaneous
  • CLL
  • C-CLL
  • Relapsed
  • Refractory
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Joe Arrington Cancer Center Lubbock, Texas  79410
Mid Ohio Oncology Hematology, Inc. Columbus, Ohio  43222
Wilshire Oncology Medical Group Glendora, California  91741
North Mississippi Hematology & Oncology Associates, Ltd. Tupelo, Mississippi  38801
Moores Cancer Center La Jolla, California  92093-0820