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:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT01484093
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated advanced stage mantle cell lymphoma (Clinical stage 2 with abdominal involvement, stage 3 and stage 4).
* Histologic diagnosis confirmed by MSKCC pathologist as mantle cell lymphoma with Cyclin D1, or D2 and/or, D3 staining performed. Presence of measurable disease as determined by FDG-PET, CT, endoscopy, colonoscopy, or bone marrow biopsy.
* Ages 18-70.
* Transplant eligibility as confirmed by the Disease Management Team.
* KPS ≥ 70%.
Adequate organ function:
* WBC ANC ≥ 1000 cells/mcL and platelet count ≥ 100,000 cells/mcL unless felt to be secondary to underlying mantle cell lymphoma at which any count is permissible.
* Adequate renal function as determined by Cr \< or = to 1.5 mg/dL or 24 hr creatinine clearance ≥ 50 ml/hr
* Adequate hepatic function as determined by total bilirubin \< or = to 1.5x ULN (unless known Gilbert syndrome) and AST \< or = to 5.0x ULN.
* Cardiac ejection fraction greater than or equal to 50% as determined by echocardiogram or MUGA.
* For patients ≥ age 60, a stress echocardiogram will be required, with same requirements as above.
* DLCO greater than or equal to 50% as determined by pulmonary function tests performed prior to initiation of treatment.
* Patients with positive Hepatitis B serologies will be treated per institutional guidelines.
Exclusion Criteria:
* Prior treatment for mantle cell lymphoma, including more than 7 days of steroids, immunotherapy, radioimmunotherapy, or chemotherapy. This does not include patients who have initiated R-CHOP at an outside institution within 2 weeks of enrollment.
* Patients using \> or = to 10mg/day of steroids for any chronic medical condition
* Pregnant or breast-feeding. Note: Pre-menopausal patients must have a negative, serum HCG within 14 days of enrollment,.
* HIV positive or Hepatitis C antibody positive.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01484093
Study Brief:
Protocol Section:
NCT01484093