EUCTR2014-004509-34-DE进行中（未招募）1 期
Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Including Patients With MYC Alterations
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Curis, Inc.
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Age = 18 years.
- •2. At least two but no more than 4 prior lines of therapy for treatment of de novo DLBCL and ineligible for (or failed) autologous or allogeneic SCT (salvage therapy, conditioning therapy and maintenance with transplant will be considered one prior treatment).
- •3. Histopathologically confirmed diagnosis of one of the following:
- •- RR DLBCL per the 2008 WHO classification of hematopoietic and
- •lymphoid tumors
- •- HGBL, with MYC and BCL2 and/or BCL6 rearrangements or DLBCL, NOS per the 2016 revision of the WHO classification of lymphoid neoplasms.
- •- Diagnosis of t-FL DLBCL is allowed. However, other B-cell lymphomas
- •including B-cell lymphoma/DLBCL unclassifiable with features
- •intermediate between DLBCL, per the 2008 WHO classification, HGBL,
- •NOS per the 2016 WHO classification, and Burkitt are not eligible.
- •4. Confirmed availability of viable tissue (defined as most recent
- •available archival tumor tissue available or fresh tumor samples) for
- •central laboratory FISH and IHC testing and review prior to study
- •dosing. Previously decalcified samples are not appropriate for FISH
- •testing. Therefore bone marrow samples are not acceptable. For subjects who enter the study with unconfirmed MYC-altered disease, fresh tumor samples are preferred.
- •5. CT scan showing at least 1 or more clearly demarcated lymph node(s)
- •with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated extranodal lesion(s) with a long axis >1.0 cm and short axis
- •>1.0 cm. All lesions must have a maximum diameter of < 10 cm.
- •Baseline FDG-PET scans, if used, must demonstrate positive lesions
- •compatible with CT-defined anatomical tumor sites.
- •6. Presence of RR disease per Revised Response Criteria for Malignant
- •· Relapsed disease is defined by DLBCL confirmed by
- •excisional/incisional biopsy (preferred) or fine needle aspiration
- •(FNA) or core needle biopsy (CNB) after a CR or unconfirmed complete
- •response (CRu).
- •- For relapse during first-line treatment, biopsy/FNA reconfirmation
- •of the lymphoma is recommended but not mandatory.
- •· Refractory disease is defined by (a) PD during first-line treatment, (b)
- •stable disease (SD) after = 3 cycles of first-line treatment, or (c) PR
- •after = 6 cycles of first line treatment, or for stage II disease, = 3 cycles
- •of treatment and definitive involved field radiotherapy. -
- •- For sustained PR after first-line treatment, confirmation biopsy for
- •DLBCL is preferred. An FNA may be acceptable, but if inappropriate (e.g. due to biopsy inaccessibility), the Sponsor may determine eligibility
- •following review of imaging results and disease history.
- •- For SD or PD after first-line treatment, reconfirmation of DLBCL by
- •biopsy (preferred) or FNA is recommended but not mandatory.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of =
排除标准
- •1. Known primary mediastinal, ocular, epidural, testicular or breast
- •2. Patients must not have active CNS involvement of their malignancy.
- •Patients with prior brain metastases are permitted, but must have
- •completed treatment and have no evidence of active CNS disease (clear
- •cerebrospinal fluid [CSF]) for at least 4 weeks prior to the first dose of
- •CUDC-907. Intrathecal chemoprophylaxis to prevent the emergence or
- •recurrence of lymphoma in the CNS is permitted on study and may be
- •administered per institutional guidelines.
- •3. Known allergy or hypersensitivity to PI3K inhibitors or any component
- •of the formulations used in this study.
- •4. Cytotoxic anticancer therapy (e.g., alkylating agents, anti-metabolites, purine analogues) or any other systemic anticancer therapy within 2 weeks of study entry.
- •5. Radiotherapy delivered to non-target lesions within one week prior to starting study treatment or delivered to target lesions that will be
- •followed on the study (note: prior sites of radiation will be recorded).
- •6. Treatment with experimental therapy within 5 terminal half-lives
- •(t1/2) or 4 weeks prior to enrollment, whichever is longer.
- •7. Current or planned glucocorticoid therapy, with the following
- •exceptions :
- •- Doses = 10 mg/day prednisolone or equivalent is allowed, provided
- •that the steroid dose has been stable or tapering for at least 14 days
- •prior to the first dose of CUDC-907.
- •- Inhaled, intranasal, intraarticular, and topical steroids are permitted
- •8. Graft versus host disease following transplant within 100 days prior to study treatment.
- •9. Major surgery, other than diagnostic surgery, occurring 4 weeks prior to study treatment.
- •10. Diabetes mellitus that is not controlled with medication.
- •11. Serious infection requiring intravenous antibiotic therapy within 14
- •days prior to study treatment.
- •12. Uncontrolled or severe cardiovascular disease, including myocardial
- •infarction, unstable angina, or atrial fibrillation (AFib) within 6 months
- •prior to study treatment, New York Heart Association (NYHA) Class II or
- •greater congestive heart failure, serious arrhythmias requiring
- •medication for treatment, clinically significant pericardial disease,
- •cardiac amyloidosis, or QTc with Fridericia's (QTcF) correction that is
- •unmeasurable or = 480 msec on screening electtrocardiogram ECG
- •(Note: for QTcF = 480 sec on the screening ECG, the ECG may be
- •repeated twice at least 24 hours apart; the mean QTcF from the three
- •screening ECGs must be < 480 msec in order to meet eligibility for trial
- •participation).
- •13. Gastrointestinal disease or disorder that could interfere with the
- •swallowing, oral absorption, or tolerance of CUDC-907. This includes
- •uncontrolled diarrhea (> 1 watery stool/day), major abdominal surgery,
- •significant bowel obstruction a
研究者
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