Clinical trial · Interventional
Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy
Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA)
NCT00003757CI-TRIAL-00006902completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Biological | Rituximab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (1)
- RESULTZenhausern 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. PMID 18603561