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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT00559104
Eligibility Criteria:
Inclusion Criteria:
* DISEASE CHARACTERISTICS:
* Biopsy-proven diagnosis of high-grade (small noncleaved cell lymphoma \[SNCCL\] or immunoblastic lymphoma) or intermediate-grade non-Hodgkin lymphoma (NHL) including mantle cell lymphoma (MCL)
* SNCCL patients with all of the following factors at presentation of disease:
* Lactate dehydrogenase (LDH) \> 500 IU/L
* Unresectable bulky mass \> 10 cm
* Stage IV disease with bone marrow involvement
* MCL Patients with stage IV disease or in International Prognostic Index (IPI) high- or high-intermediate-risk group at the time of diagnosis
* Considered at diagnosis to be high- (3 risk factors) or high-intermediate-risk (2 risk factors) based on an age-adjusted IPI
* Poor prognostic factors at diagnosis include stage III or IV disease, lactate dehydrogenase (LDH) level above normal, or ECOG performance status (PS) 2-4
* Patients with primary mediastinal large cell lymphoma with or without sclerosis who at diagnosis had elevated LDH level with bulky mediastinal mass \> 10 cm associated with a pleural effusion on chest radiography or computer tomography, or who have persistent mediastinal mass with positive disease by post-treatment gallium GA 67 scan
* Must have attained a complete response or partial response to first-line standard conventional chemotherapy
* ECOG PS 0-1 OR Karnofsky PS 80-100%
* Serum creatinine \< 1.5 mg/dL OR creatinine clearance \> 60 mL/min
* FEV\_1 \> 65% of predicted measurement or DLCO ≥ 45% of predicted measurement
* Cardiac ejection fraction \> 50% by echocardiogram
* Bilirubin ≤ 1.5 x normal
* SGOT or SGPT ≤ 2 x normal
Exclusion Criteria:
* Evidence of lymphoma or \< 10% lymphomatous involvement of bone by bilateral bone marrow aspiration and biopsy
* Abnormal cytogenetic study of bone marrow aspirate sample NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
* Positive HIV antibody
* Prior malignancies except for adequately treated basal cell or squamous cell carcinoma of the skin
* Hepatitis B surface antigen positivity
* Prior bone marrow transplantation
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior bone marrow transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
59 Years
Study:
NCT00559104
Study Brief:
Protocol Section:
NCT00559104