Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-32/98 | |||
| EU-98074 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Patients showing complete or partial remission at evaluation on day 71 of the first treatment course do not receive any further treatment until relapse or disease progression is evident.
Patients showing minor or no response on day 71 of the first treatment course receive a subsequent course of standard dose 2-CDA.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 4 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDA day | Active Comparator | CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5 |
|
| CDA week | Active Comparator | CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-chlorodeoxyadenosine (CDA) daily | Drug | Daily administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acute hematotoxicity at 10 weeks following study treatment | 10 weeks | |
| Acute infection rate at 10 weeks following study treatment | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital admission frequency and length at 10 weeks following study treatment | 10 weeks | |
| Blood support at 10 weeks following study treatment | 10 weeks | |
| Remission rate |
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Reinhard Zenhaeusern, MD | Insel Gruppe AG, University Hospital Bern | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19672771 | Result | Zenhausern 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015463 | Leukemia, Prolymphocytic |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017338 | Cladribine |
| ID | Term |
|---|---|
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2-chlorodeoxyadenosine weekly |
| Drug |
Weekly administration |
|
| 10 weeks |
| Remission duration | 10 weeks |
| Relapse-free survival | 10 weeks |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |