Clinical trial · Interventional
Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia
Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if giving cladribine once a day is more effective than giving cladribine once a week in patients with hairy cell leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of cladribine given once a day to cladribine given once a week in treating patients with hairy cell leukemia.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-chlorodeoxyadenosine (CDA) daily | Drug | — | UNRESOLVED |
| 2-chlorodeoxyadenosine weekly | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CDA day
- description
- CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5
- interventionNames
- Drug: 2-chlorodeoxyadenosine (CDA) daily
- type
- ACTIVE_COMPARATOR
- label
- CDA week
- description
- CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5
- interventionNames
- Drug: 2-chlorodeoxyadenosine weekly
Primary outcomes (2)
- measure
- Acute hematotoxicity at 10 weeks following study treatment
- timeFrame
- 10 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed classic form or prolymphocytic variant hairy cell leukemia (HCL) * Newly diagnosed HCL or progressive disease after prior treatment PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * NCI 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 Other: * HIV negative * Not pregnant * No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin PRIOR CONCURRENT THERAPY: * At least 4 weeks since any prior therapy and recovered Biologic therapy: * Not specified Chemotherapy: * No concurrent cytoreductive therapy * No prior cladribine Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (1)
- RESULTZenhausern R, Schmitz SF, Solenthaler M, Heim D, Meyer-Monard S, Hess U, Leoncini L, Bargetzi M, Rufener B, Tobler A. Randomized trial of daily versus weekly administration of 2-chlorodeoxyadenosine in patients with hairy cell leukemia: a multicenter phase III trial (SAKK 32/98). Leuk Lymphoma. 2009 Sep;50(9):1501-11. doi: 10.1080/10428190903131755. PMID 19672771