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CAMPATH-1H Compassionate Treatment In Patients With PLL Who Have Failed At Least One Prior Regimen And CLL Patients Who Have Failed Fludarabine Therapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

CAMPATH-1H Compassionate Treatment In Patients With PLL Who Have Failed At Least One Prior Regimen And CLL Patients Who Have Failed Fludarabine Therapy


OBJECTIVES: I. Expand access to Campath-1H for patients with refractory prolymphocytic
leukemia or chronic lymphocytic leukemia.

OUTLINE: Patients receive Campath-1H IV over 2 hours on days 1, 3, and 5. Treatment repeats
weekly for 4-12 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Not specified

Inclusion Criteria


DISEASE CHARACTERISTICS: Confirmed prolymphocytic leukemia (PLL) or chronic lymphocytic
leukemia (CLL) PLL that has failed at least 1 prior regimen CLL that has failed prior
fludarabine, defined as: No response Disease progression while receiving therapy OR
Relapse within 6 months of completion of last dose

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper
limit of normal (ULN) (unless secondary to direct liver infiltration with CLL) Renal:
Creatinine no greater than 2 times ULN Other: HIV negative No active infection No other
severe concurrent disease No mental disorders No prior allergic reaction to rat or
mouse-derived CDR-grafted humanized monoclonal antibodies Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 3 weeks since prior chemotherapy No concurrent cytotoxic therapy
Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy
Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Bernard J. Silver, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospitals Seidman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068755

NCT ID:

NCT00021151

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Leukemia
  • refractory chronic lymphocytic leukemia
  • prolymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Prolymphocytic

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065