Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
Completed · Phase 2
Conditions studied: Lymphoma
In brief
RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The patient's stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with or without total-body irradiation followed by a stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma.
Key facts
- Study ID
- NCT00559104
- Run by
- City of Hope Medical Center
- People needed
- 60
- Starts
- 1998-10-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2015-08-11
Who can join
Age: 16 and older, up to 59. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Good Samaritan Regional Medical Center — Phoenix, Arizona, United States
- City of Hope National Medical Center--Main Campus — Duarte, California, United States
Full record on ClinicalTrials.gov
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