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B-Cell Chronic Lymphocytic LeukemiaPhase 2NCT01576588

Rituximab in Pretreated Elderly or Unfit B-CLL Patients

A Phase 2 study testing Rituximab and Glucocorticoid in people with B-Cell Chronic Lymphocytic Leukemia, run by Prof. Dr. Med. Laimonas Griskevicius at 1 site in Lithuania.

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 study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Chronic Lymphocytic Leukemia
What is being tested?
Rituximab and Glucocorticoid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteLithuania
Study dates
Oct 2011to Jun 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • The diagnosis of CD20 positive chronic B lymphocytic leukemia (BCLL) confirmed by biopsy or flow-cytometry.
  • Previously treated patients with stage Rai I-IV and progressive disease (according to IWCLL 2008 guidelines).
  • Active B-CLL is defined by at least one of the following:
  • At least one of the disease related symptoms:
  • Constitutional symptoms:
  • Weight loss >10% within the previous 6 months;
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  • Fatigue (e.g., WHO performance status >/=2);
  • Fever >/=38C >/=2 weeks without evidence of infection;
  • Night sweats for more than 1 month without evidence of infection.
  • Evidence of progressive marrow failure as manifested by development of, or worsening of, anemia and/or thrombocytopenia
  • Autoimmune hemolysis and/or thrombocytopenia poorly responsive to corticosteroid therapy.
  • Massive (i.e., >/=6 cm bellow left costal margin) or progressive or symptomatic splenomegaly.
  • Massive lymphadenopathy or conglomerates (i.e., >/=10 cm in largest diameter) or progressive or symptomatic lymphadenopathy.
  • Progressive lymphocytosis with an increase >50% over a 2-month period or an anticipated doubling time of less than 6 months. In patients with initial blood lymphocyte counts of less than 30x10^9/L LDT should not be used as a single parameter to define treatment indication. Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy.
  • Either of the following:
  • 18 years of age or older with impaired performance status (CIRS > 6) and /or
  • 65 years of age or older with any performance status.
  • Signed informed consent form.

Who cannot join

  • Intolerance to exogenous protein or known severe reaction to the administration of Rituximab.
  • Active infection.
  • Cancer radiotherapy, biological therapy or chemotherapy within 3 weeks prior to Study Day 1.
  • TBC or fungal infection within the past 6 months even if adequately controlled by treatment.
  • Severe organ deficiency preventing the participation in the study.
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.
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  • Active peptic ulcer.
  • Inadequately controlled diabetes mellitus.
  • Suspected or confirmed B-CLL CNS disease.
  • Known to be HIV positive.
  • Difficult to control, uncooperative patients.
  • Allergic disorders in need of chronic glucocorticoid therapy.
  • Other oncological diseases requiring active treatment (except hormonal therapy).
  • Pregnancy and breastfeeding.
  • Patients of reproductive potential who are not using effective methods of contraception.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, 08661

Other trials in Lithuania

About this study

Official title: Study of Rituximab in Addition to Glucocorticoid in Pretreated Elderly or Unfit Patients With Chronic B Lymphocytic Leukemia

The study will test the efficacy rituximab in addition to glucocorticoids for the treatment of B-CLL in elderly or unfit patients.

Read the detailed description

Patient Population: Pretreated patients with symptomatic B-CLL 18-64 years of age with poor performance status or >/=65 years of age with any performance status.

Treatment: Up-to 4 cycles of glucocorticoid (Methylprednisolone or Dexamethasone) and Rituximab every 21 day.

Study Duration: The study period for each subject is expected to be 21 months. Subjects will receive up-to 4 cycles of IV infusion of Rituximab and Glucocorticoid. Maximum duration of treatment is expected to be 6 months. Subjects will complete scheduled visits not later than Study Month 21, thereafter they will enter into the long-term follow-up period. Subjects will be followed every 3 months for disease progression, initiation of subsequent leukemia treatment or survival.

Being tested
Rituximab, Glucocorticoid
Keywords
Chronic lymphocytic leukemia, relapsed, elderly or unfit patients, methylprednisolone, rituximab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence

What participants receive

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

  • RituximabDrug

    Also called MabThera

    Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).

  • GlucocorticoidDrug

    Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.

Study groups in NCT01576588
Study groupRoleWhat they receive
R-HDMPExperimentalRituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4). Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Receives: Drug: Rituximab; Drug: Glucocorticoid

What is being measured

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

  1. Overall Response Rate

    Overall response rate (ORR) is defined according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2008) guidelines, as the proportion of patients achieving complete response (CR), CR with minimal residual disease (MRD) negativity (complete molecular remission), nodular partial remission (nPR) and partial response (PR).

    Measured: 3 months +/- 2 weeks after the last treatment cycle.

Secondary outcomes (3)

  1. Progression Free Survival

    Progression free survival (PFS) will be defined as the interval from entry into the study to disease progression or death.

    Measured: up to 12 months

  2. Number of Participants With Adverse Events

    Adverse events NCI CTCAE, version 4.0. Hematological toxicity was evaluated according to IWCLL 2008 guidelines.

    Measured: 6 months.

  3. Overall Survival

    Overall survival (OS) will be defined as the interval from date of randomization until the date of death from any cause, assessed up to 100 months.

    Measured: from date of randomization until the date of death from any cause, assessed up to 100 months

Timeline

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

  1. First posted12 Apr 2012 (estimated)
  2. Study startOct 2011
  3. Primary completionJan 2016
  4. Study completionJun 2019

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01576588
Sponsor's protocol ID
LT-CLL-2s
Status last verified
Dec 2019
First submitted
9 Mar 2012
Last updated
27 Dec 2019
Data monitoring committee
No

Publications

  • Pileckyte R, Jurgutis M, Valceckiene V, Stoskus M, Gineikiene E, Sejoniene J, Degulys A, Zvirblis T, Griskevicius L. Dose-dense high-dose methylprednisolone and rituximab in the treatment of relapsed or refractory high-risk chronic lymphocytic leukemia. Leuk Lymphoma. 2011 Jun;52(6):1055-65. doi: 10.3109/10428194.2011.562572.

    PubMed 21599591

  • Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner H, Hillmen P, Keating MJ, Montserrat E, Rai KR, Kipps TJ; International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008 Jun 15;111(12):5446-56. doi: 10.1182/blood-2007-06-093906. Epub 2008 Jan 23.

    PubMed 18216293

  • Pileckyte R, Valceckiene V, Stoskus M, Matuzeviciene R, Sejoniene J, Zvirblis T, Griskevicius L. Dose Intensive Rituximab and High-Dose Methylprednisolone in Elderly or Unfit Patients with Relapsed Chronic Lymphocytic Leukemia. Medicina (Kaunas). 2019 Oct 29;55(11):719. doi: 10.3390/medicina55110719.

    PubMed 31671877

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and Glucocorticoid in people with B-Cell Chronic Lymphocytic Leukemia, run by Prof. Dr. Med. Laimonas Griskevicius at 1 site in Lithuania.

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 18 inclusion and 15 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 27 Dec 2019. 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 Lithuania. 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?

Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (time frame: 3 months +/- 2 weeks after the last treatment cycle.). 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 NCT01576588, which also lists 3 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 27 Dec 2019.

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