A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin - PRELUDE
- Conditions
- High-risk diffuse large B-cell lymphoma (DLBCL)
- Registration Number
- EUCTR2005-004630-41-GR
- Lead Sponsor
- Eli Lilly and Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 459
[1] have had a histologically confirmed diagnosis of DLBCL by the World
Health Organization classification (Harris et al. 1999) at the time of
original diagnosis. Pathology must be reviewed and confirmed prior
to enrollment at the investigational site where the patient is entered.
Patients may be entered and randomized based on local pathology;
however, an independent centralized pathology review will be
performed on all enrolled patients (see Section 6.4.1). Commonly
accepted histological variants of DLBCL, such as immunoblastic
lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich Bcell
lymphoma are allowed.
[2] if any gallium scan was performed, the most recent gallium scan must
be negative. However, gallium scans are not a required study
procedure.
[3] if any PET scan was performed, the most recent PET scan must be
negative, as judged by local radiologist and/or physician (an
independent centralized radiology review will also be performed on
these patients). Exceptions may be made (after consultation with the
Lilly clinical research physician) for patients with PET-positive lesions
in which a subsequent confirmation procedure (for instance, biopsy)
reveals the lesion is not due to DLBCL. However, PET scans are not a
required study procedure. (See Section 6.1.1 for more information.)
[4] have completed six to eight 21-day cycles of R-CHOP, or six to eight
14-day cycles of R-CHOP as first-line therapy for DLBCL. (Refer to
Section 5.5 for recommended regimens.) The patient must have
achieved a CR or CRu (and have not subsequently progressed)
according to International Workshop criteria (Cheson et al. 1999), or
must be PET scan negative (according to Juweid et al. 2007), as
judged by local radiologist and/or physician (an independent
centralized radiology review will also be performed on these patients).
Exceptions may be made (after consultation with the Lilly clinical
research physician) for patients with PET-positive lesions in which a
subsequent confirmation procedure (for instance, biopsy) reveals the
lesion is not due to DLBCL.
[5] have an IPI score =3 at time of original diagnosis (refer to Protocol
Attachment JCBJ.4).
[6] have had Stage 3 or 4 disease, or have had Stage 2 with bulky disease
(defined as =10 cm), at time of original diagnosis.
[7] have given informed consent.
[8] have an estimated life expectancy of at least 12 weeks.
[9] have a performance status of 0, 1, or 2 on the Eastern Cooperative
Oncology Group (ECOG) scale (see Protocol Attachment JCBJ.7;
Oken et al. 1982).
[10] exhibit patient compliance and geographic proximity that allow for
adequate follow-up.
[11] have adequate organ function as follows:
• Hepatic: total bilirubin =1.5 times upper limit of normal (ULN);
alanine transaminase (ALT) and aspartate transaminase (AST)
=2.5 times ULN
• Renal: serum creatinine <1.5 times ULN
• Adequate bone marrow reserve: platelets =50 x 109/L, absolute
neutrophil count (ANC) =1.0 x 109/L, hemoglobin =8 g/dL.
[12] male and female patients with reproductive potential must use an
approved contraceptive method, if appropriate (for example,
intrauterine device [IUD], birth control pills, or barrier device) during
and for 3 months after discontinuation of study treatment. Women
with childbearing potential must have a negative serum pregnancy test
within 7 days prior to study enrollment.
[13] are at least 18 years of age.
[14] patients must receive on-study therapy no later than 90 days either
from their last cycle (Day
[15] have received treatment within the last 30 days with a drug that has not
received regulatory approval for any indication at the time of study
entry.
[16] receive concurrent administration of any other systemic anticancer
therapy. Patients who had been receiving chronic therapy such as
hormonal therapy (for example, tamoxifen), low-dose (7.5 mg/week)
methotrexate, or corticosteroids prior to the diagnosis and treatment of
DLBCL, may continue to receive these therapies while on study, after
agreement with the Lilly clinical research physician; however,
initiation of these medications while the patient is on study is not
allowed. Intrathecal prophylaxis is allowed.
[17] have received radiation therapy to more than one targeted lesion (local
residual disease) for treatment of lymphoma or have not recovered
from the acute effects of radiation therapy prior to study entry.
[18] are pregnant or breastfeeding.
[19] have central nervous system (CNS) metastases (unless the patient has
completed successful local therapy for CNS metastases and has been
off of corticosteroids for at least 4 weeks before starting study
therapy). In the absence of a clinical suspicion of brain metastases, no
screening computed tomography (CT) or magnetic resonance imaging
(MRI) scan before enrollment is required.
[20] have serious concomitant disorder, including active bacterial, fungal,
or viral infection, incompatible with the study (at the discretion of the
investigator).
[21] are known to be HIV positive.
[22] have a second primary malignancy (except adequately treated nonmelanomatous
skin cancer, or other cancer that is considered cured by
surgical resection or radiation). Patients who had another malignancy
in the past, but have been disease-free for more than 5 years, are
eligible.
[23] have a serious cardiac condition, such as myocardial infarction within
6 months, angina, or heart disease, as defined by the New York Heart
Association Class III or IV (see Protocol Attachment JCBJ.5).
[24] are unable to swallow tablets.
[25] requires use of carbamazepine, phenobarbital, or phenytoin (refer to
Section 5.7).
[26] prior stem cell or bone marrow transplantation.
[27] a prior clinical history of an indolent lymphoma.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method