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AzTrials

LeukemiaPhase 2NCT00072007

Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With CLL

A Phase 2 study testing filgrastim, rituximab and CHOP regimen in people with Leukemia, run by Swiss Cancer Institute at 11 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Leukemia
What is being tested?
filgrastim, rituximab and CHOP regimen
How many people
43 participants
Where
11 sitesSwitzerland
Study dates
Jun 2002to Oct 2010
Phase
Phase 2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL)
  • CD5 positive and CD23 positive
  • Binet stage B, C, or progressive A
  • Newly diagnosed disease OR no more than 1 prior alkylating agent regimen (e.g., chlorambucil or cyclophosphamide with or without prednisone)

PATIENT CHARACTERISTICS:

Age

  • 18 to 65

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • No autoimmune hemolytic anemia
  • No immune thrombocytopenia

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN*
  • AST and ALT no greater than 2.5 times ULN* NOTE: *Unless clearly related to CLL liver involvement

Renal

  • Creatinine clearance greater than 50 mL/min

Cardiovascular

  • Ejection fraction at least 50%
  • No severe heart failure
  • No unstable angina pectoris
  • No significant arrhythmia requiring chronic treatment
  • No myocardial infarction within the past 3 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after study participation
  • HIV negative
  • No active infection
  • No positive Coombs' test
  • No history of significant neurologic or psychiatric disorders, including psychotic disorders or dementia
  • No seizure disorder
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
  • No prior allergic reaction or hypersensitivity to study drugs or attributed to compounds of similar chemical or biological composition to study drugs or other study agents
  • No uncontrolled diabetes mellitus
  • No gastric ulcers
  • No active autoimmune disease
  • No alcohol or drug abuse
  • No other concurrent serious underlying medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No prior purine analogs (e.g., cladribine or fludarabine)

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • More than 30 days since prior clinical trial participation
  • No other concurrent experimental drugs

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Switzerland11 sites

  • Kantonspital Aarau

    Aarau, 5001

  • Oncology Institute of Southern Switzerland

    Bellinzona, CH-6500

  • Inselspital Bern

    Bern, CH-3010

  • Spitaeler Chur AG

    Chur, CH-7000

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital, Luzerne

    Luzerne, CH-6000

  • Hopital des Cadolles, Neuchatel

    Neuchâtel, 2000

  • Praxis Dr. Beretta

    Rheinfelden, 4310

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Onkozentrum

    Zurich, 8038

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: 2-CDA and Rituximab as Remission Induction and Rituximab as In Vivo Purging Prior to Peripheral Stem Cell Mobilization in Patients With Chronic Lymphocytic Leukemia (CLL) - A Prospective Multicenter Phase II Trial

RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cladribine with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving cladribine and rituximab as remission induction therapy together with rituximab and stem cell mobilization in treating patients with chronic lymphocytic leukemia.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy and tolerability of cladribine and rituximab as remission induction therapy in patients with chronic lymphocytic leukemia.
  • Determine the complete remission rate in patients treated with this regimen.

Secondary

  • Determine the very good partial remission rate and nodular partial remission rate in patients treated with this regimen.
  • Determine the toxicity of this regimen, in terms of hemotoxicity and infection rate, in these patients.
  • Determine the efficacy of in vivo purging with rituximab measured by immunophenotyping in these patients.
  • Determine the feasibility of stem cell harvest in these patients after treatment with this induction therapy regimen and in vivo purging with rituximab.

OUTLINE: This is a multicenter study.

  • Remission induction: Patients receive cladribine subcutaneously (SC) on days 1-5. During courses 2-4, patients also receive rituximab IV on day 1. Treatment repeats every 28 days for up to 4 courses in the absence of unacceptable toxicity. If unacceptable toxicity persists, patients receive rituximab alone.

Patients not achieving a complete remission (CR), very good partial remission (VGPR), or nodular partial remission (NPR) receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for up to 4 courses or until patients achieve a CR, VGPR, or NPR.

Patients achieving a CR, VGPR, or NPR proceed to stem cell mobilization and in vivo purging.

  • Stem cell mobilization and in vivo purging: Beginning 8-10 weeks after the first day of the last course of remission induction or CHOP, patients receive rituximab IV on days 1 and 8, cyclophosphamide IV over 4 hours on day 2, and filgrastim (G-CSF) SC daily beginning on day 4 and continuing until the last day of apheresis. Patients undergo apheresis on days 11-14.

PROJECTED ACCRUAL: A total of 17-41 patients will be accrued for this study within 3 years.

Conditions
Leukemia
Being tested
filgrastim, rituximab, CHOP regimen, cladribine, cyclophosphamide
Keywords
B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia
Medical subject headings
Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete-remission rate after induction

    Measured: 30 days

Secondary outcomes (2)

  1. Very good partial remission and nodular partial remission after induction

    Measured: 30 days

  2. Toxicity (hematotoxicity and infection rate) at 30 days following study treatment

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2003 (estimated)
  2. Study startJun 2002
  3. Primary completionMar 2003
  4. Study completionOct 2010

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072007
Sponsor's protocol ID
SAKK 34/02
Other IDs
EU-20321
Status last verified
May 2012
First submitted
4 Nov 2003
Last updated
15 May 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Leupin N, Schuller JC, Solenthaler M, Heim D, Rovo A, Beretta K, Gregor M, Bargetzi MJ, Brauchli P, Himmelmann A, Hanselmann S, Zenhausern R. Efficacy of rituximab and cladribine in patients with chronic lymphocytic leukemia and feasibility of stem cell mobilization: a prospective multicenter phase II trial (protocol SAKK 34/02). Leuk Lymphoma. 2010 Apr;51(4):613-9. doi: 10.3109/10428191003624231.

    PubMed 20218808

  • Leupin N, Schuller JC, Solenthaler M, et al.: The combination of 2-CDA and rituximab in patients with chronic lymphocytic leukemia (CLL): a prospective multicenter phase II trial (SAKK 34/02). [Abstract] Blood 110 (11): A-2057, 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, rituximab and CHOP regimen in people with Leukemia, run by Swiss Cancer Institute at 11 sites 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 11 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Complete-remission rate after induction (time frame: 30 days). 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 NCT00072007, which also lists 2 linked publications.

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.

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