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:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-22 @ 2:14 PM
NCT ID:
NCT00882895
Eligibility Criteria:
Inclusion Criteria
* Age 18 to 70 years.
* Histologically proven non-Hodgkin's lymphoma
* High risk disease including at least one of the following:
* Relapsed or refractory disease
* Transformed lymphoma
* Aggressive T-cell lymphoma
* Failure to achieve completed remission (CR) following Auto SCT
* Less than a 20% chance of event-free survival from autologous transplant determined by the treating physician and the Principal Investigator
* ECOG performance status \< or = 2
* Underwent Autologous SCT 60-120 days prior to registration including:
* BEAM conditioning (BCNU: 300 mg/m2 IV day -7, Etoposide: 100 mg/m2 IV BID days -6,-5,-4,-3, Cytarabine: 100 mg/m2 IV BID days -6,-5,-4,-3, Melphalan: 140 mg/m2 IV day -2)
* Minimum of 2 x 106 CD34+ cells/kg infused
* Full hematologic recovery following Auto HCT including:
* Absolute neutrophil count (ANC) \>1000 µl
* Platelet count of ≥50,000 µl independent of transfusion for \>7 days
* Available matched related or unrelated donor. Selected donor must be a complete match or have only a single antigen mismatch.
* Women of child-bearing potential and sexually active males must use an accepted and effective method of birth control.
* Bone marrow comprising of \< 10% lymphoma on most recent biopsy/aspiration (within 9 months of Allo transplant; may have been performed prior to autologous transplant).
* Serum bilirubin \< or = 2 x the institutional ULN
* Serum creatinine \< or = 2 x the institutional ULN and measured or estimated creatinine clearance \> 60 cc/min by the following formula
* Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female 72X serum creatinine(mg/dl).
* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria
* Prior autologous or allogeneic hematopoietic cell transplantation (other than autologous SCT 60-120 days prior to registration)
* Prior radioimmunotherapy
* Known or suspected progressive disease following autologous SCT
* Additional treatment for NHL administered from time of autologous SCT through registration
* Pregnant or breast-feeding women (due to the known birth defects association with the treatments used in this study)
* Human immunodeficiency virus (HIV)-positive (the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population.)
* Any prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.
* Active infection requiring oral or intravenous antibiotics.
Inclusion of Women and Minorities
-Both men and women and members of all races and ethnic groups are eligible for this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00882895
Study Brief:
Protocol Section:
NCT00882895