LeukemiaPhase 3NCT00003746
Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia
A Phase 3 study testing 2-chlorodeoxyadenosine (CDA) daily and 2-chlorodeoxyadenosine weekly in people with Leukemia, run by Swiss Cancer Institute at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- 2-chlorodeoxyadenosine (CDA) daily and 2-chlorodeoxyadenosine weekly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 1998to Nov 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
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.
Read the detailed description
OBJECTIVES:
- Compare the acute hematotoxicity and infection rate with daily and weekly administration of cladribine in patients with hairy cell leukemia.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive daily subcutaneous bolus injections of cladribine (2-CDA) for 5 days (standard dose).
- Arm II: Patients receive weekly subcutaneous bolus injections of 2-CDA for 5 weeks.
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.
- Conditions
- Leukemia
- Being tested
- 2-chlorodeoxyadenosine (CDA) daily, 2-chlorodeoxyadenosine weekly
- Keywords
- untreated hairy cell leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia
- Medical subject headings
- Leukemia, Leukemia, Prolymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-chlorodeoxyadenosine (CDA) dailyDrug
Daily administration
2-chlorodeoxyadenosine weeklyDrug
Weekly administration
| Study group | Role | What they receive |
|---|---|---|
| CDA day | Active comparator | CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5 Receives: Drug: 2-chlorodeoxyadenosine (CDA) daily |
| CDA week | Active comparator | CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5 Receives: Drug: 2-chlorodeoxyadenosine weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute hematotoxicity at 10 weeks following study treatment
Measured: 10 weeks
Acute infection rate at 10 weeks following study treatment
Measured: 10 weeks
Secondary outcomes (5)
Hospital admission frequency and length at 10 weeks following study treatment
Measured: 10 weeks
Blood support at 10 weeks following study treatment
Measured: 10 weeks
Remission rate
Measured: 10 weeks
Remission duration
Measured: 10 weeks
Relapse-free survival
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1998
- Primary completionNov 2005
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reinhard Zenhaeusern, MD, Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003746
- Sponsor's protocol ID
- SAKK 32/98
- Other IDs
- SWS-SAKK-32/98, EU-98074
- Status last verified
- May 2012
- First submitted
- 1 Nov 1999
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19672771
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
- ClinicalTrials.gov ID
- NCT00003746
- Acronym / sponsor ID
- SAKK 32/98
- Conditions
- Leukemia
- Keywords
- untreated hairy cell leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Swiss Cancer InstituteUniversity, hospital or other
- Study start
- Sep 1998
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Compare the acute hematotoxicity and infection rate with daily and weekly administration of cladribine in patients with hairy cell leukemia.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive daily subcutaneous bolus injections of cladribine (2-CDA) for 5 days (standard dose).
- Arm II: Patients receive weekly subcutaneous bolus injections of 2-CDA for 5 weeks.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDA day | Active comparator | Drug: 2-chlorodeoxyadenosine (CDA) dailyCDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5 |
| CDA week | Active comparator | Drug: 2-chlorodeoxyadenosine weeklyCDA:0.14 mg/kg/week Bolus s.c. weeks 1-5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-chlorodeoxyadenosine (CDA) dailyDaily administration | Drug | CDA day |
| 2-chlorodeoxyadenosine weeklyWeekly administration | Drug | CDA week |
Primary outcome
Acute hematotoxicity at 10 weeks following study treatment
Time frame: 10 weeks
Acute infection rate at 10 weeks following study treatment
Time frame: 10 weeks
5 secondary outcomes
Hospital admission frequency and length at 10 weeks following study treatment
Time frame: 10 weeks
Blood support at 10 weeks following study treatment
Time frame: 10 weeks
Remission rate
Time frame: 10 weeks
Remission duration
Time frame: 10 weeks
Relapse-free survival
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Results publication: PubMed 19672771Zenhausern 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinhard Zenhaeusern, MD study chair
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2-chlorodeoxyadenosine (CDA) daily and 2-chlorodeoxyadenosine weekly in people with Leukemia, run by Swiss Cancer Institute at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute hematotoxicity at 10 weeks following study treatment (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.