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B-cell Chronic Lymphocytic LeukemiaPhase 2NCT00565981

A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response

A Phase 2 study testing Fludarabine phosphate and Alemtuzumab in people with B-cell Chronic Lymphocytic Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 8 sites in Austria.

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

Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4 cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg alemtuzumab s.c. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
B-cell Chronic Lymphocytic Leukemia
What is being tested?
Fludarabine phosphate and Alemtuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
8 sitesAustria
Study dates
Mar 2004to 13 Feb 2008
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 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients with CD23+, CD5+, CD19+, light chain monoclonal B CLL
  • 1st or 2nd relapse after fludarabine or any other primary treatment regimen or refractory to primary or secondary treatment (including fludarabine) and simultaneously indication for treatment according to the NCI Workshop Criteria 1996
  • Age 19-75
  • WHO performance score 0-2
  • Informed consent given by the patient

Who cannot join

  • HIV positive or positive for Hepatitis B or C
  • active uncontrolled infection
  • child bearing age without adequate control of fertility, pregnant or lactating women
  • intolerance towards any ingredient of either oral fludarabine or alemtuzumab
  • allergy against foreign proteins
  • previous treatment with alemtuzumab
Show all 12Show fewer
  • treatment with an experimental drug within the previous 2 months
  • second malignant disease (non CLL)
  • CLL in transformation (Richter syndrome)
  • decreased kidney-function with creatinine-clearance < 30ml/min
  • severe concomitant diseases or major organ dysfunctions
  • patients who are unable to comply with the requirements of the protocol

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Austria8 sites

  • Landeskrankenhaus Feldkirch

    Feldkirch, A-6806

  • A.ö. Landeskrankenhaus Fürstenfeld

    Fürstenfeld, A-8280

  • Universitätsklinik Innsbruck/ Klinik für Innere Medizin

    Innsbruck, A-6020

  • A.ö. Landeskrankenhaus Leoben

    Leoben, A-8700

  • Krankenhaus der Stadt Linz

    Linz, A-4020

  • St. Johanns LK

    Salzburg, A-5020

  • A.ö. Krankenhaus der Landeshauptstadt St. Pölten

    Sankt Pölten, A-3100

  • Klinikum Kreuzschwestern Wels GmbH

    Wels, A-4600

Other trials in Austria

About this study

Official title: Subcutaneous MabCampath® (Alemtuzumab) and Oral Fludara® (Fludarabinephosphate) for the Treatment of Refractory or Relapsed Chronic Lymphocytic Leukemia in 2nd or 3rd Line of Treatment: A Pilot Trial (FLUSALEM) for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response

Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4 cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg alemtuzumab s.c. in patients with B-CLL disease in 1st and 2nd relapse after any primary treatment or with disease refractory to any therapy in 1st or 2nd line (including Fludarabine, ). This regimen is preceded by an escalation phase with 3-10-30 mg of alemtuzumab s.c.

After the first phase (completed treatment of 7 patients) an interim analysis of safety and efficacy will be performed. In case of a sufficient risk benefit assessment followed by the enrollment of further 21 patients. Final analysis of safety and preliminary efficacy will be based on all patients enrolled.

Being tested
Fludarabine phosphate, Alemtuzumab
Keywords
B-CLL, refractory, molecular profiling, alemtuzumab, fludarabinephosphate
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • Fludarabine phosphateDrug

    Also called Fludara®

    orally, 40 mg/m2 d1-3 q4w, x4 cycles

  • AlemtuzumabDrug

    Also called MabCampath®

    subcutaneous, starting dose 3 mg and escalation to 10 mg, then 30 mg, followed by 30 mg thrice weekly for 16 weeks in escalated dose

Study groups in NCT00565981
Study groupRoleWhat they receive
Overall studyExperimentalThe FLUSALEM protocol combines 4 cycles of oral fludarabine phosphate (40mg/m² d1-3; q 29d) and an intensive dose schedule of alemtuzumab (30mg sc.3 times weekly for 16 weeks) in an outpatient setting
Receives: Drug: Fludarabine phosphate; Drug: Alemtuzumab

What is being measured

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

  1. Safety and tolerability

    Measured: within the duration of study

  2. Complete and overall response rate

    Measured: within the duration of study

  3. Infections grade III, IV

    Measured: within the duration of study

  4. Rate of CMV reactivation

    Measured: within the duration of study

Secondary outcomes (5)

  1. Time to retreatment

    Measured: within duration of trial

  2. Overall survival

    Measured: within duration of trial

  3. Response in lymphatic compartments

    Measured: within duration of trial

  4. Molecular response/ immunologic MRD response

    Measured: within duration of trial

  5. Quality of Life

    Measured: within duration of trial

Timeline

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

  1. First posted30 Nov 2007 (estimated)
  2. Study startMar 2004
  3. Primary completion13 Feb 2008
  4. Study completion13 Feb 2008

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00565981
Sponsor's protocol ID
FLUSALEM
Status last verified
Dec 2017
First submitted
29 Nov 2007
Last updated
7 Dec 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fludarabine phosphate and Alemtuzumab in people with B-cell Chronic Lymphocytic Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 8 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. 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 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Austria. 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?

Safety and tolerability (time frame: within the duration of study). The study lists 4 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 NCT00565981.

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 7 Dec 2017.

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