CompletedNCT01576588Updated Dec 27, 2019Results posted

Rituximab in Pretreated Elderly or Unfit B-CLL Patients

A Phase 2 interventional study of Rituximab and Glucocorticoid in B-Cell Chronic Lymphocytic Leukemia, sponsored by Prof. Dr. Med. Laimonas Griskevicius. Completed at 1 site in Lithuania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-27.

Sponsored by Prof. Dr. Med. Laimonas Griskevicius · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 5 months after the study started (first participant enrolled Oct 2011, registered Mar 2012).

Phase: Phase 2
Study type: Interventional
Enrollment: 25
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

B-Cell Chronic Lymphocytic Leukemia

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Keywords

Chronic lymphocytic leukemia, relapsed, elderly or unfit patients, methylprednisolone, rituximab

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 25 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

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Lead sponsor

This is the only study on the registry with Prof. Dr. Med. Laimonas Griskevicius as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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;
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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 25 participants (actual)

Study arms

Experimental
R-HDMP
Rituximab (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.
Drug: Rituximab · Drug: Glucocorticoid

Interventions

DrugRituximab
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Also known as: MabThera
DrugGlucocorticoid
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.

What researchers measure

Primary outcomes

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).
Time frame: 3 months +/- 2 weeks after the last treatment cycle.

Secondary outcomes

Progression Free Survival
Progression free survival (PFS) will be defined as the interval from entry into the study to disease progression or death.
Time frame: up to 12 months
Number of Participants With Adverse Events
Adverse events NCI CTCAE, version 4.0. Hematological toxicity was evaluated according to IWCLL 2008 guidelines.
Time frame: 6 months.
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.
Time frame: from date of randomization until the date of death from any cause, assessed up to 100 months

Results

Posted Dec 16, 2019

Participant flow

Participant flow — Overall Study
Milestone	R-HDMP
Started	25
Completed	23
Not completed	2

Outcome measures

PrimaryOverall 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).

Time frame:: 3 months +/- 2 weeks after the last treatment cycle.
Reported as:: Count of participants · Participants

Overall Response Rate
Participants	R-HDMP
Overall Response Rate	7

SecondaryProgression Free Survival

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

Time frame:: up to 12 months
Reported as:: Median · months

Progression Free Survival
months	R-HDMP
Progression Free Survival	11 (10 to 12)

SecondaryNumber of Participants With Adverse Events

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

Time frame:: 6 months.
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events
Participants	R-HDMP
Number of Participants With Adverse Events	23

SecondaryOverall 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.

Time frame:: from date of randomization until the date of death from any cause, assessed up to 100 months
Reported as:: Median · months

Overall Survival
months	R-HDMP
Overall Survival	68 (47 to 89)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
R-HDMP	—	9/25 (36%)	23/25 (92%)

Most frequent serious events

Most frequent serious events
Event	R-HDMP
Febrile neutropeniaBlood and lymphatic system disorders	3/25
NeutropeniaBlood and lymphatic system disorders	2/25
DiareaGastrointestinal disorders	2/25
ExtrasystoliaCardiac disorders	1/25
Orfarin overdosageSocial circumstances	1/25
Upper pulmonary infectionRespiratory, thoracic and mediastinal disorders	1/25
Left femur cervical stress fractureMusculoskeletal and connective tissue disorders	1/25
Renal insufficiencyRenal and urinary disorders	1/25
ThrombocytopeniaBlood and lymphatic system disorders	1/25

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	R-HDMP
HypokalemiaMetabolism and nutrition disorders	15/25
HypertentionCardiac disorders	4/25
FeverInfections and infestations	3/25
InsomniaNervous system disorders	3/25
HyperglycemiaEndocrine disorders	2/25
AnemiaBlood and lymphatic system disorders	2/25
CoughRespiratory, thoracic and mediastinal disorders	2/25
Chest discomfort/painCardiac disorders	2/25
HeadacheNervous system disorders	2/25
hypomagnesemiaMetabolism and nutrition disorders	2/25

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	R-HDMP
<=18 years	0
Between 18 and 65 years	0
>=65 years	25

Age, Continuous
Age, Continuous(years)	R-HDMP
Median	73 (65 to 80)

Sex: Female, Male
Sex: Female, Male(Participants)	R-HDMP
Female	18
Male	7

Region of Enrollment
Region of Enrollment(Participants)	R-HDMP
Lithuania	25

Study locations

1 site

Vilnius University Hospital Santaros Klinikos
Vilnius, 08661, Lithuania

References and documents

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. Erratum In: Blood. 2008 Dec 15;112(13):5259. 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01576588
Lead sponsor: Prof. Dr. Med. Laimonas Griskevicius
Responsible party: Prof. Dr. Med. Laimonas Griskevicius (Principal Investigator, Vilnius University) — Sponsor-investigator
First posted: Apr 12, 2012
Start date: Oct 2011
Primary completion: Jan 2016
Completion: Jun 2019
Results posted: Dec 16, 2019
Last update: Dec 27, 2019

Study contacts

Laimonas Griskevicius, MD

principal investigator · Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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