Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

rituximab

About this trial

This is an interventional treatment trial for Leukemia focused on measuring progressive hairy cell leukemia, initial treatment, refractory hairy cell leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinik Hirslanden

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003757

First Posted

November 1, 1999

Last Updated

May 14, 2012

Sponsor

Swiss Group for Clinical Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT00003757

Brief Title

Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

February 1998 (undefined)

Primary Completion Date

July 2002 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Group for Clinical Cancer Research

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy consisting of rituximab in treating patients with refractory or recurrent hairy cell leukemia following cladribine therapy.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia

Keywords

progressive hairy cell leukemia, initial treatment, refractory hairy cell leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

rituximab

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albert von Rohr, MD

Organizational Affiliation

Klinik Hirslanden, Zurich

Official's Role

Study Chair

Facility Information:

Facility Name

Klinik Hirslanden

City

Zurich

ZIP/Postal Code

CH-8008

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

18603561

Citation

Zenhausern R, Simcock M, Gratwohl A, Hess U, Bargetzi M, Tobler A; Swiss Group for Clinical Cancer Research (SAKK). Rituximab in patients with hairy cell leukemia relapsing after treatment with 2-chlorodeoxyadenosine (SAKK 31/98). Haematologica. 2008 Sep;93(9):1426-8. doi: 10.3324/haematol.11564. Epub 2008 Jul 4. No abstract available.

Results Reference

result

Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial