Sandra Horning
Phase II Poor Risk Diffuse Large B-cell Lymphoma (DLBCL) of Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation (AHCT)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to develop an alternative treatment for patients with relapsed diffuse large B cell lymphoma who are not likely to be cured by the conventional transplantation regimen.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Procedure: Total lymphoid irradiation (TLI)
- Drug: Anti-thymocyte globulin (ATG)
- Procedure: Allogeneic hematopoietic cell transplantation
- Procedure: Autologous hematopoietic cell transplantation (AHCT)
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to 70 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Age 18 to 70 years.
- Histologically proven diffuse large B-cell lymphoma (DLBCL) by the WHO classification.
- Relapse after achieving initial remission or failure to achieve initial remission. Patients with residual radiographic abnormalities after primary therapy are eligible if abnormalities are FDG-PET positive.
- Receipt of 2 cycles of second-line therapy and FDG-PET positive per Stanford (central) review. FDG-PET to be done 2 weeks after cycle 2 of second line chemotherapy.
- ECOG performance status < 2
- Matched related or unrelated donor identified and available
- Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration
- Women of child-bearing potential and sexually active males are strongly advised to use an accepted and effective method of birth control.
- Patients must have a pretreatment serum bilirubin < 2 x the institutional ULN, a serum creatinine < 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula (all tests must be performed within 28 days prior to registration):
* Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female
72X serum creatinine(mg/dl).
- Patients must have an EKG within 42 days prior to registration that shows no significant abnormalities that are suggestive of active cardiac disease.
- Patients requiring therapy for coronary artery disease, cardiomyopathy, dysrhythmia, or congestive heart failure are not eligible.
- Patients must have a radionuclide ejection fraction within 42 days of registration. If the ejection fraction is <40%, the patient will not be eligible. If the ejection fraction is 40-50%, the patient will have a cardiology consult.
- Patients must have a corrected diffusion capacity >55%.
- Patients with known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide are not eligible.
- Patients with > grade 2 sensory or motor peripheral neuropathy from prior vinca alkaloid use are not eligible.
- 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.
Key Exclusion Criteria:
- Pregnant or breast-feeding women are ineligible due to the known birth defects association with the treatments used in this study.
- Patients known to be human immunodeficiency virus (HIV)-positive are ineligible because the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population. The antibody test for HIV must be performed within 42 days of registration.
- No chemotherapy other than corticosteroids should be administered within 2 weeks of the initiation of protocol therapy.
- No 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. Patients with a prior diagnosis of non-Hodgkin's lymphoma are not eligible.
- Patients with active infection requiring oral or intraveneous antibiotics are excluded.
- No prior autologous or allogeneic hematopoietic cell transplantation.
- No prior radioimmunotherapy
Donor Selection/Evaluation:
- Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation.
- No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 16 ?g/kg of body weight.
- Donors will be evaluated with a full history and physical examination.
- Virology testing including CMV, HIV, EBV, HTLV, RPR, Hepatitis A, B and C will be performed within 30 days of donation.
- Prospective donors will be screened for CMV seroreactivity and seronegative donors will be utilized if available. If the possibility of more than one HLA-matched related donor exists, then the donor will be selected on the basis of CD31 allotype.
Additional Study Details
Official Title:
A Phase II Study in Poor Risk Diffuse Large B-cell Lymphoma (DLBCL) of Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) Followed by Matched Allogeneic Hematopoietic Transplantation as a Consolidation to Autologous Hematopoietic Cell Transplantation (AHCT)Anticipated start date:
10/12/2006Lead Sponsor:
Stanford UniversityCollaborator(s):
- National Institutes of Health (NIH)
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
UnspecifiedPrimary Outcomes:
- To estimate event-free survival and toxicity in poor risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to AHCT.
Secondary Outcomes:
- To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism.
- To evaluate the incidence and extent of chronic GVHD.
- To evaluate the overall and transplant related mortality rate.
Total Number to be Enrolled:
30Total Number to be Enrolled at Stanford:
30More Information
Secondary ID(s):
- 97355
- BMT186
- NCT00482053
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/1/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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