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Leukemia, Lymphocytic, Chronic, B-CellPhase 1/2NCT00738829

Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL

A Phase 1/2 study testing Lenalidomide, Fludarabine and Rituximab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 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

The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Lymphocytic, Chronic, B-Cell
What is being tested?
Lenalidomide, Fludarabine and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
7 sitesAustria
Study dates
Oct 2008to Jan 2012
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • B-CLL (CD23+, CD5+, CD19+, CD20+)
  • Treatment indication according to NCI criteria
  • Age >= 18 yrs
  • No previous treatment of CLL by chemo-, radio- or immunotherapy
  • Life expectancy > 6 months
  • Written informed consent
  • Women of non-childbearing potential or women of childbearing potential and men using effective contraception

Who cannot join

  • Active bacterial, viral or fungal infection
  • Positivity for HIV, Hepatitis B or C
  • Reduce organ functions and bone marrow dysfunction not due to CLL
  • Creatinine clearance below 30 ml/min
  • Patients with medical conditions requiring long-term use of systemic corticosteroids during study treatment
  • Patients with a history of severe cardiac disease
Show all 11Show fewer
  • Other known co-morbidity with the potential to dominate survival
  • Transformation to aggressive B-cell malignancy
  • Known hypersensitivity to humanised monoclonal antibodies or any of the study drugs
  • Pregnant or breast-feeding women
  • Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Austria7 sites

  • Landeskrankenhaus Feldkirch

    Feldkirch, A-6806

  • Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie

    Innsbruck, Tyrol, A-6020

  • Krankenhaus d. Barmherzigen Schwestern Linz

    Linz, A-4010

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, A-4010

  • Krankenhaus der Stadt Linz

    Linz, A-4020

  • Universitaetsklinik f. Innere Medizin III

    Salzburg, A-5020

  • Klinikum Wels-Grieskirchen GmbH

    Wels, A-4600

Other trials in Austria

About this study

Official title: Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide Followed by Rituximab/Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Concomitant Evaluation of Safety and Efficacy.

The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.

Read the detailed description

This is a non-randomized, multicenter, open-label, single-arm Phase I/II study in patients with previously untreated CD20-positive CLL. Phase I of the study will evaluate the maximal tolerated lenalidomide dose level in combination with fludarabine/rituximab chemoimmunotherapy in 10 patients. Phase II will determine efficacy using the combination in the previously defined maximal tolerated dose. Both phases will be followed by a maintenance phase evaluating the tolerability and possibility to further improve response quality.

Keywords
CLL, untreated, immune therapy, dose escalation, maximum tolerated dose, maintenance therapy, Lenalidomide, Rituximab, Fludarabine
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.

  • LenalidomideDrug

    Also called Revlimid

    Dose escalation stage: starting dose 2.5mg/d, dose escalation via 5/10/15/20/25 mg/d every 28 days if no dose-limiting toxicity.

    During maintenance stage dosing on days 1-28 for max. 6 months at maximum tolerated dose reached during dose escalation stage.

  • FludarabineDrug

    Also called Fludarabine phosphate

    25 mg/m2 i.v. d1-3 or 40 mg/m2 po d1-3 every 28 days for 6 cycles during dose escalation stage.

  • RituximabBiological

    Also called MabThera

    Dose escalation stage: 375 mg/m2 i.v. d4 Cycle 1, 500 mg/m2 i.v. d1 Cycles 2-6.

    Maintenance stage: 375 mg/m2 i.v. at 2/4/6 months after end of escalation stage.

Study groups in NCT00738829
Study groupRoleWhat they receive
Treatment ArmExperimentalLenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy
Receives: Drug: Lenalidomide; Drug: Fludarabine; Biological: Rituximab

What is being measured

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

  1. Lenalidomide Maximum Tolerated Dose

    Measured: Dose escalation stage

Secondary outcomes (7)

  1. Safety profile of Lenalidomide/Fludarabine/Rituximab treatment

    Measured: Study Duration

  2. Safety Profile of Lenalidomide/Rituximab

    Measured: Study duration

  3. Response rate for Lenalidomide/Fludarabine/Rituximab combination treatment

    Measured: Dose escalation stage

  4. Response rate for Lenalidomide/Rituximab combination therapy

    Measured: Study Duration

  5. Response rate by 4-colour flow cytometric MRD analysis

    Measured: Study Duration

  6. Changes in Quality of Life scores

    Measured: Study Duration

  7. Risk factors and clonal evolution

    Measured: Study Duration

Timeline

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

  1. First posted21 Aug 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJan 2012
  4. Study completionJan 2012

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00738829
Sponsor's protocol ID
CLL-5
Other IDs
EudraCT Nr. 2008-001430-27, ML21718
Status last verified
Aug 2013
First submitted
20 Aug 2008
Last updated
30 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Egle A, Steurer M, Melchardt T, Weiss L, Gassner FJ, Zaborsky N, Geisberger R, Catakovic K, Hartmann TN, Pleyer L, Voskova D, Thaler J, Lang A, Girschikofsky M, Petzer A, Greil R. Fludarabine and rituximab with escalating doses of lenalidomide followed by lenalidomide/rituximab maintenance in previously untreated chronic lymphocytic leukaemia (CLL): the REVLIRIT CLL-5 AGMT phase I/II study. Ann Hematol. 2018 Oct;97(10):1825-1839. doi: 10.1007/s00277-018-3380-z. Epub 2018 Jun 4.

    PubMed 29862437

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide, Fludarabine and Rituximab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 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 7 inclusion and 11 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 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Lenalidomide Maximum Tolerated Dose (time frame: Dose escalation stage). 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 NCT00738829, 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 30 Aug 2013.

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