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Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA)


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA)


OBJECTIVES:

- Determine the rate of complete and partial remission, remission duration, and relapse
free survival after treatment with rituximab in patients with refractory or recurrent
hairy cell leukemia who previously received cladribine.

- Determine the acute and long term toxicity of rituximab in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive rituximab IV over several hours once a week for 4 weeks.

Patients are followed every 3 months for 3 years and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 8-25 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven hairy cell leukemia (HCL)

- Classic HCL

- Hairy cells in the bone marrow and/or peripheral blood which co-express
CD20/CD25 or CD20/CD11c, and/or which are positive for tartrate resistant
acid phophatase (TRAP)

- Prolymphocytic HCL variant

- Lymphoid cells in the bone marrow and/or peripheral blood with morphology
intermediate between typical hairy cells and prolymphocytes, which
co-express CD20/CD11c but lack CD25 expression, and which are negative for
TRAP

- Progressive or recurrent disease after prior treatment with cladribine

- Greater than 1 month since standard dose cladribine OR

- Greater than 3 months since low dose cladribine

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- WHO 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

Renal:

- Creatinine no greater than 2.3 mg/dL

Cardiovascular:

- No serious cardiac disease

Other:

- No acute or chronic infection

- HIV negative

- No psychosis

- Not pregnant or nursing

- No other prior or concurrent malignancy except carcinoma in situ of the cervix or
basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- Recovered from prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- Recovered from prior therapy

- No concurrent cytoreductive therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Albert von Rohr, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Klinik Hirslanden

Authority:

Switzerland: Swissmedic

Study ID:

SAKK 31/98

NCT ID:

NCT00003757

Start Date:

February 1998

Completion Date:

July 2007

Related Keywords:

  • Leukemia
  • progressive hairy cell leukemia, initial treatment
  • refractory hairy cell leukemia
  • Leukemia
  • Leukemia, Hairy Cell

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