The objective of this study is to gather more information to find out if one of these rituximab administration methods is more effective and safer in the treatment of DLBCL patients. This study will also collect information on patient satisfaction…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective for this study is to estimate the efficacy of rituximab
administered subcutaneously (SC) or intravenously (IV) in combination with
cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP), as measured
by complete response rate (including
complete response unconfirmed; CR/CRu) approximately one month after the end of
rituximabbased treatment.
Secondary outcome
• To compare patient satisfaction with rituximab SC versus rituximab IV in
patients with diffuse large B-cell lymphoma (DLBCL), as measured by the
validated Cancer Treatment Satisfaction Questionnaire (CTSQ) and the Rituximab
Administration Satisfaction Questionnaire (RASQ).
• To evaluate the effects of method of administration (rituximab SC or
rituximab IV) in terms of:
- Rituximab administration time, defined as the time from start to end of the
rituximab SC injection or from start to end of the rituximab IV infusion
- Chair time defined as the time the patient occupies an infusion chair/bed for
a single treatment cycle of R-CHOP immunochemotherapy
- Hospital time, defined as the time the patient is in hospital for the course
of one cycle of R-CHOP immunochemotherapy.
• To evaluate event-free survival (EFS), disease-free survival (DFS),
progression-free survival (PFS) and overall survival (OS) from randomization.
• To evaluate the safety of rituximab SC compared with rituximab IV in patients
with DLBCL, focusing on serious adverse events (SAEs), Grade >= 3 adverse events
(AEs), and Grade >= 3 application associated reactions (AAR) and infusion
related reactions (IRR)) according to National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI CTCAE version 4.0).
Background summary
Roche is investigating the subcutaneous injection into the skin of rituximab
(referred to as subcutaneous rituximab) compared to the intravenous rituximab
administration. Compared to IV administration, the SC injection will only take
5 to 6 minutes. This simple SC injection will allow the time of patient stay to
reduce significantly compared to IV administration. This reduction will also
apply to hospital burden associated with IV administration. Additionally, Roche
expects that the subcutaneous administration will increase patient
satisfaction, ease of administration and treatment compliance.
Study objective
The objective of this study is to gather more information to find out if one of
these rituximab administration methods is more effective and safer in the
treatment of DLBCL patients. This study will also collect information on
patient satisfaction with the rituximab treatment and on the time spent in the
hospital during the rituximab treatment.
Study design
This is a Phase IIIb, prospective, multi-centre, multinational, open label
randomized study in approximately 600 adult patients with previously untreated
CD20-positive DLBCL.
Patients will be randomized to either group A or B in a 2:1 ratio. All patients
will receive 8 cycles of rituximab treatment (unless unacceptable side effects
occur or the disease does not improve or progresses) in combination with either
6 or 8 cycles of CHOP-21, or 6 or 8 cycles of CHOP-14. Rituximab will be
administered on the same day, prior to the CHOP administration, or on the day
before CHOP administration, for a total of 8 treatment cycles. Patients
receiving rituximab with 6 cycles of CHOP-14 will receive 2 additional cycles
consisting of rituximab only, for a total of 8 cycles of rituximab (without
CHOP).
Patients in groep A will receive rituximab IV for their first treatment cycle,
followed by SC rituximab for the remaining 7 treatment cycles. If patients in
group A have a reaction to the first treatment with IV rituximab or are unable
to receive the full dose, they will continue to receive IV rituximab for their
secont treatment cycle.
Patients in group B will receive rituximab IV for all 8 treatment cycles.
Intervention
Patients eligible for participation in the study will be treated according to
the specific study schedule in protocol v3.0, 20 March 2013 (appendix 1, page
98-100).
Study burden and risks
The study procedures and treatments may be associated with risks and may cause
discomfort. There is a risk of slight pain or bruising when blood is collected.
Bone marrow sampling may give a risk of serious bleeding and/or infection where
the sample is taken, but these are rare.
Undergoing MRI or CT scans exposes the patient to low dose of radiation. The
dye used in some CT scans and MRIs may cause serious allergic reactions that
can be life-threatening without treatment.
There may be side effects associate with rituximab IV; fever and chills, nausea
(feeling like you are going to throw up), vomiting (throwing up), fatigue
(feeling tired or weak), headache, skin rash, redness of the skin, itchiness,
wheezing or tightness in the chest, shortness of breath, difficulty breathing,
sensation of the tongue or throat swelling, throat irritation, rhinitis (runny
nose), temporary low blood pressure, flushing, dizziness on standing up, fast
heartbeat, chest pain, or pain where the tumour is located. These side effects
are usually mild to moderate and can be easily treated. Rarely, these reactions
can be severe. These side effects are less common after the first treatment
with IV rituximab.
Treatment with rituximab may cause a higher risk for infection due to the way
rituximab works to kill blood and tumour cells.
Very common side effects have been seen in at least 1 person for every 10
people receiving rituximab with or without chemotherapy in a research study.
These include infections caused by viruses or bacteria; bronchitis; fever;
chills; low white blood cell count with or without a fever; low antibodies in
the blood (antibodies help fight infection); low blood platelets (platelets
help control bleeding); swelling of the face, lips, mouth or throat (this may
cause difficulty in swallowing or breathing); nausea; muscle weakness; skin
rash; itching; headache; and hair loss.
Common side effects have been seen in at least 1 person for every 100 people
receiving rituximab with or without chemotherapy in a cancer research study.
These include blood infections; lung and airway infections; fungal infections;
shingles (itchy tingling areas, usually on your trunk, that become painful
blisters); hepatitis B infection; cold symptoms; changes to the blood (such as
changes that lower the bloods ability to provide oxygen to the tissues, fight
infection and to prevent bleeding as well lower levels of calcium and higher
levels of sugar and cholesterol); widening of the blood vessels; swelling of
the hands, feet or ankles; numbness; numbness with a prickly feeling; allergic
reactions; hives; skin problems; eye tearing; eye infection; ear pain; ringing
in the ears; heart beat abnormalities, heart attack, and other heart problems
(these can result in chest pain and noticeable changes to your heart beat);
chest pain; high blood pressure; low blood pressure; inflammation, irritation
and/or tightness of the lungs; shortness of breath; cough; rhinitis (stuffy
nose); sinusitis (stuffy sinuses); mouth inflammation; difficulty swallowing;
throat irritation; indigestion; abdominal pain; vomiting; diarrhoea;
constipation; loss of appetite; weight loss; fatigue; dizziness; shivering;
sweating; trouble sleeping; night sweats; agitation; anxiety; malaise;
reddening of the face and body; increased muscle tension; muscle pain; joint
pain; back pain; neck pain; and tumour pain.
Uncommon side effects have been seen in at least 1 person for every 1000 people
receiving rituximab with or without chemotherapy in a research study. These
include: bleeding; depression; nervousness; change to sense of taste; blood
clotting problems; swelling of the lymph nodes; asthma; lung problems including
inflammation and scarring that narrow the airways; not enough oxygen to the
body; abdominal swelling ; and pain at the site where rituximab was given.
Beneluxlaan 2a
Woerden 3446GR
NL
Beneluxlaan 2a
Woerden 3446GR
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 and <= 80 years at time of study inclusion ;• Histologically confirmed, previously untreated CD20-positive DLBCL according to the WHO classification system;• Patients with an IPI score of 1-5 or IPI score of 0 with bulky disease, defined as one lesion >= 7.5 cm;• At least one bi-dimensionally measurable lesion defined as >= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI;• Adequate hematologic function;• Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Exclusion criteria
• Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis ;• Transformed lymphoma or follicular lymphoma IIIB ;• Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation ;• History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >= 5 years prior to enrolment ;• Inadequate renal or hepatic function ;• Known human immunodeficiency virus (HIV) infection or HIV seropositive status ;• Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection ;• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products ;• Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines ;• Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody ;• Pregnant or lactating women
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000669-19-NL |
| Other | Het onderzoek is onder het EudraCT nummer terug te vinden op www.rochetrials.com |
| CCMO | NL41113.056.12 |