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Subcutaneous Campath-1H in Fludarabine-Refractory CLL


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

Subcutaneous Campath-1H in Fludarabine-Refractory CLL


OBJECTIVES:

- Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab
in patients with fludarabine-refractory advanced chronic lymphocytic leukemia.

- Determine the response in patients with high-risk genetic abnormalities (unmutated
immunoglobulin variable heavy-chain [IgVH] status, del [17p], del [11q]) treated with
subcutaneous alemtuzumab after progression on fludarabine.

OUTLINE: This is a multicenter study.

Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously
once weekly for up to 12 weeks.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Confirmed diagnosis of previously treated advanced chronic lymphocytic leukemia (CLL)

- Fludarabine-refractory disease

- Requires treatment

PATIENT CHARACTERISTICS:

- Life expectancy more than 6 months

- ECOG 0-2

- No severe organ dysfunction

- No other concomitant or previous neoplasms

- No autoimmune hemolytic anemia or thrombocytopenia

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Up to 5 prior chemotherapy regimens allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and efficacy

Safety Issue:

Yes

Principal Investigator

Stephan Stilgenbauer, MD

Investigator Affiliation:

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Authority:

United States: Federal Government

Study ID:

CDR0000455059

NCT ID:

NCT00274976

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Leukemia
  • refractory chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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