Rituximab in Pretreated Elderly or Unfit B-CLL Patients

NCT01576588 | Completed Phase 2 Results

• 1 other identifier: LT-CLL-2s
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

B-Cell Chronic Lymphocytic Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (3)

• Progression Free Survival

  up to 12 months

• Number of Participants With Adverse Events

  6 months.

• Overall Survival

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

Study Arms (1)

R-HDMP

EXPERIMENTAL

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

Rituximab DRUG

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

R-HDMP

Glucocorticoid DRUG

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.

R-HDMP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Dr. Med. Laimonas Griskevicius: lead

Study Sites (1)

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

Related Publications (3)

• 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.

  PMID: 21599591 BACKGROUND

• 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.

  PMID: 18216293 BACKGROUND

• 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.

  PMID: 31671877 RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Recurrence

Interventions

Rituximab; Glucocorticoids

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Regina Pileckyte, investigator
• Organization: Vilnius University Hospital Santaros Klinikos

regina.pileckyte@santa.lt

+370 5 2501384

Study Officials

• Laimonas Griskevicius, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: April 12, 2012
• Study Start: October 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2019
• Last Updated: December 27, 2019
• Results First Posted: December 16, 2019

Record last verified: 2019-12

Locations

LI (1)