Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT01307592
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed aggressive non-Hodgkin lymphoma, including any of the following subtypes:
* Follicular large cell lymphoma
* Diffuse large cell lymphoma
* Peripheral T-cell lymphoma
* Transformed lymphoma
* Lymphoblastic lymphoma
* Burkitt or Burkitt-like lymphoma
* Refractory or relapsed disease meeting the following criteria:
* Patients who either did not respond to prior therapy or whose best response was partial response after ≥ 4 courses of chemotherapy
* Histologic confirmation of relapsed or refractory disease is desirable but not mandatory and will be left to the discretion of the investigator
* Must have evaluable or measurable disease
* Patients who are candidates for stem cell or bone marrow transplantation allowed
* No CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Absolute neutrophil count ≥ 1,000/mm³ (unless due to marrow infiltration by lymphoma)
* Platelet count ≥ 100,000/mm³ (unless thrombocytopenia is due to marrow infiltration by lymphoma)
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless liver is involved with lymphoma, hemolysis, or Gilbert syndrome)
* Serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 30 ml/min (unless creatinine elevation is due to lymphoma)
* ALT ≤ 2 times ULN (≤ 5 times ULN if liver metastasis is involved with lymphoma)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy
* Men must use latex condoms even after a successful vasectomy
* Must be enrolled in the mandatory RevAssist® program and be willing to comply with its requirements
* No neurosensory or neuromotor dysfunction ≥ grade 3
* No known HIV positivity or active hepatitis B or C (hepatitis B surface antigen positivity or hepatitis C RNA positivity)
* No known hypersensitivity to thalidomide or erythema nodosum characterized by desquamating rash while taking thalidomide or other similar drugs
* No history of allergy to platinum or any of its derivatives or E. coli-derived products
* No other malignancies within the past 5 years, except treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or any surgically cured malignancy from which the patient has been disease-free for ≥ 5 years
* No NYHA class III-IV congestive heat failure (no symptoms on less than ordinary exertion or at rest)
* No uncontrolled or intercurrent disease, including any of the following:
* Arrhythmias
* Angina pectoris
* Active infection or fever \> 38.2 C (unless due to lymphoma)
* No serious medical condition, laboratory abnormality, or psychiatric illness that would place patient at risk in study or confound ability to interpret study data
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior gemcitabine hydrochloride, oxaliplatin, or lenalidomide
* Prior rituximab allowed
* No more than 4 prior regimens of chemotherapy allowed, including stem cell or bone marrow transplantation
* More than 2 weeks since prior and no concurrent anticancer therapy, including radiotherapy, hormonal therapy, or surgery
* More than 3 weeks since prior chemotherapy or radiotherapy
* More than 28 days since prior and no other concurrent investigational drug trial or investigational agent
* Able to take aspirin (81 mg or 325 mg) daily or low molecular weight heparin as prophylactic anticoagulation
* No concurrent thalidomide
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01307592
Study Brief:
Protocol Section:
NCT01307592