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 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT00250861
Eligibility Criteria:
INCLUSION CRITERIA:
A patient will be eligible for inclusion in this study if s/he meets all of the following criteria:
* Has previously undergone BEAC or BEAM autologus SCT with PBSC rescue for any stage aggressive B-cell NHL, including transformed indolent NHL or mantle cell lymphoma according to REAL classification - only B-cell lymphomas are permitted.
* ECOG performance status 0-1.
* Previously histological documented CD20 +NHL.
* Is greater than 18 years of age.
* Is 30-100 days from autologous peripheral blood stem cell transplant.
* Must meet laboratory values (see protocol for values): Absolute neutrophils, hemoglobin and platelets.
* Has a negative serum pregnancy test within 7 days prior to trial registration (only for female patients of childbearing potential).
* If fertile, patient (male or female) has agreed to use physician-approved method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.
* Has signed a Patient Informed Consent Form.
* Has signed a Patient Authorization Form (HIPAA).
EXCLUSION CRITERIA:
Patients will be taken off treatment if any of the following occur:
* ECOG PS \>2.
* A history of hypersensitivity to study drugs, or any component thereof, or anaphylactic history to murine protein.
* Manifested cardiac complications during transplant, including arrthymias, congestive heart failure, angina, or myocardial infarct, or had a decreased LVEF to \<45% prior to transplant
* On systemic corticosteroids.
* Diffusion capacity \<60% (corrected) and has decreased 30% or more following transplant
* Documented disease progression (See Section 10.1.6 for definition).
* Active infection, and/or is known to be seropositive for hepatitis B, hepatitis C, or HIV
* Pericardial effusion, pleural effusions, or ascites.
* A history of very aggressive NHL, such as Burkitt's or atypical Burkitt's lymphoma
* Receiving concurrent immunotherapy or rituximab therapy.
* Previously received a solid organ transplant.
* History of CNS involvement.
* A serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
* A history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.
* A pregnant or nursing woman.
* Unable to comply with requirements of study.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00250861
Study Brief:
Protocol Section:
NCT00250861