Status:
ACTIVE_NOT_RECRUITING
Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma
Lead Sponsor:
Washington University School of Medicine
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a research study testing a new approach to treating high-risk non-Hodgkin's lymphoma consisting of an autologous hematopoietic (blood) stem cell transplant (using a patient's own hematopoietic...
Detailed Description
The approach to recurrent or primary refractory non-Hodgkin's lymphoma has been to treat patients with second-line chemotherapy (usually 2-3 courses) for the purposes of cytoreduction and to establish...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00882895
Start Date
May 5 2009
End Date
June 1 2028
Last Update
January 28 2025
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110