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Chronic B-Lymphocytic LeukemiaPhase 2LT-CLL-001NCT00558181

High-dose Methylprednisolone and Rituximab in High Risk B-CLL

A Phase 2 study testing rituximab, methylprednisolone in people with Chronic B-Lymphocytic Leukemia, run by Vilnius University at 2 sites 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

Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53 apoptosis pathway. The combination of both drugs may improve response and outcome in previously treated high-risk B-CLL patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic B-Lymphocytic Leukemia
What is being tested?
rituximab, methylprednisolone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesLithuania
Study dates
Sep 2007to Dec 2009
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 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 (B-CLL) confirmed by biopsy or flow-cytometry.
  • Relapsed or progressive disease after at least 1 prior chemotherapy.
  • Stage Rai I-IV and progressive disease (according to NCI criteria). NCI progressive disease criteria16
  • Active B-CLL is defined by at least one of the following:
  • At least one of the disease related symptoms:
  • Constitutional symptoms:
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  • Weight loss more 10 percent within the previous 6 months;
  • Fatigue (e. g. WHO performance status 2 or more);
  • Fever 38C or more 2 weeks or more without evidence of infection;
  • Night sweats without evidence of infection.
  • Evidence of progressive marrow failure as manifested by:
  • anemia (less 110 g/l) and / or
  • thrombocytopenia (less 100 x 109/l) within the previous 6 months and / or
  • neutropenia (less 1 x 109/l) within the previous 6 months.
  • Autoimmune hemolysis and / or thrombocytopenia poorly responsive to corticosteroid therapy.
  • Massive (i. e.6 cm or more bellow left costal margin) or progressive splenomegaly with progressive increase on 2 consecutive visits at least 2 weeks apart.
  • Massive lymphadenopathy or conglomerates (i.e., 10 cm or more in largest diameter) or progressive lymphadenopathy with increase on 2 consecutive visits at least 2 weeks apart.
  • Progressive lymphocytosis with an increase more 50 percent over a 2-month period or an anticipated doubling time of less than 6 months.
  • 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
  • 1. High-risk B-CLL biologically or clinically:
  • Biologically high-risk B-CLL is defined by the presence of at least one of the following factors:
  • 98 percent or more lgVH genes are homologous to the embryonic sequence and / or
  • 17p del confirmed by FISH or
  • 11q del confirmed by FISH or
  • 12 trisomy.
  • Clinically high-risk B-CLL is defined by the presence of at least one of the following factors:
  • Progressive or stable disease while on Fludarabine treatment.
  • Relapse after Fludarabine treatment within 12 months.
  • Older than 18 years.
  • 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.
Show all 16Show fewer
  • Severe liver disease (total bilirubin or transaminases more 3 times ULN), except caused by the B-CLL.
  • 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

2 sites in 1 country.

Lithuania2 sites

  • Klaipeda Seamen's Hospital

    Klaipėda, Klaipėda County, 92288

  • Vilnius University Hospital Santariskiu Clinics

    Vilnius, Vilnius County, 08661

Other trials in Lithuania

About this study

Official title: Phase II Study of High-dose Methylprednisolone and Rituximab in Previously Treated Patients With High Risk Chronic B Lymphocytic Leukemia

Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53 apoptosis pathway. The combination of both drugs may improve response and outcome in previously treated high-risk B-CLL patients.

Study Objectives

Primary:

To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate.

Secondary:

To determine progression free and overall survival. To characterize the safety profile of high-dose Methylprednisolone and Rituximab.

Read the detailed description

Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53 apoptosis pathway. The combination of both drugs may improve response and outcome in previously treated high-risk B-CLL patients.

Study Objectives

Primary:

To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate.

Secondary:

To determine progression free and overall survival. To characterize the safety profile of high-dose Methylprednisolone and Rituximab.

Patient Population Patients with previously treated symptomatic high risk B-CLL 18 years of age and older.

Study Duration The study period for each subject is expected to be 21 months. Subjects will receive up-to 6 cycles of IV infusion of Methylprednisolone and Rituximab. Maximum duration of treatment is expected to be 9 months. All infusions of study treatment will be administered by medically qualified site staff in an inpatient or outpatient clinic under the supervision of an Investigator. Subjects will complete scheduled visits not later than Study Month 21, after which time 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, except in cases lost to follow up, or if a subject withdraws informed consent.

Study Design Phase II, multicenter, non-randomized, open label study.

Maximum Recruitment Period 2 years

Number of Planned Subjects Approximately 50 patients.

Being tested
rituximab, methylprednisolone
Keywords
B CLL, Chronic B Lymphocytic Leukemia, Methylprednisolone, Rituximab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, B-Cell

What participants receive

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

  • rituximab, methylprednisoloneDrug

    Subjects will receive up-to 6 courses of IV infusion of Methylprednisolone and Rituximab every 21 day.

Study groups in NCT00558181
Study groupRoleWhat they receive
Rituximab, MethylprednisoloneExperimentalNot described
Receives: Drug: rituximab, methylprednisolone

What is being measured

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

  1. Primary endpoint will be the ORR defined as the proportion of patients achieving CR, CR with MRD negativity (Complete Flow Cytometric Remission), nPR and PR.

    Measured: End of treatment.

Secondary outcomes (1)

  1. PFS defined as time from the first day of treatment to the day the subject progresses or dies of any cause. OS defined as time from the first day of treatment to the day the subject dies of any cause.

    Measured: End of treatment.

Timeline

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

  1. First posted14 Nov 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionJan 2009
  4. Study completionDec 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00558181
Sponsor's protocol ID
LT-CLL-001
Acronym
LT-CLL-001
Status last verified
Feb 2010
First submitted
13 Nov 2007
Last updated
23 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, methylprednisolone in people with Chronic B-Lymphocytic Leukemia, run by Vilnius University at 2 sites 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 30 inclusion and 16 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 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Primary endpoint will be the ORR defined as the proportion of patients achieving CR, CR with MRD negativity (Complete Flow Cytometric Remission), nPR and PR. (time frame: End of treatment.). 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 NCT00558181.

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 23 Feb 2010.

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