Trial Search Results
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
The purpose of this trial is to develop an alternative treatment for patients with poor risk non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem cell transplant using the patient's own cells. This is followed with non-myeloablative transplant using stem cells from a related or unrelated donor to try and generate an anti-lymphoma response from the new immune system.
Stanford is currently not accepting patients for this trial.
- Drug: Cyclophosphamide
- Drug: BCNU
- Drug: Etoposide
- Drug: Filgrastim
- Drug: Antithymocyte globulin
- Drug: Cyclosporine
- Drug: Mycophenolate mofetil
- Drug: Rituximab
- Procedure: Autologous hematopoietic stem cell transplantation (auto-HSCT)
- Procedure: Allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Procedure: Total lymphoid irradiation
- Drug: CD34+ Cells
- Drug: Solu-Medrol
- Age 18 to 70 years.
- Histologically proven non-Hodgkin's lymphoma
- Relapse after achieving initial remission or failure to achieve initial remission.
- KPS > 70%
- Matched related or unrelated donor identified and available. Donor must be a complete
match or have only a single allele mismatch.
- Recent Bone marrow biopsy and cytogenetic analysis
- 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
> 50 cc/min by the following formula (all tests must be performed within 28 days prior
to mobilization ): Estimated Creatinine Clearance = (140 age) X WT(kg) X 0.85 if
female 72 X 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 must have an echocardiogram or MUGA scan within 42 days of registration. If
the ejection fraction is < 40%, the patient will not be eligible. If the ejection
fraction is 40-50%, patients must have an exercise echocardiogram or dobutamine-echo
with a normal response to exercise.
- Patients must have a corrected diffusion capacity > 50% prior to the autologous
transplant and > 40% prior to the allogeneic transplant.
- Patients with known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis
with cyclophosphamide 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
- 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.
- Patients with prior maligancies diagnosed > 5 years ago without evidence of disease
are eligible. Patients with a prior malignancy treated < 5 years ago but have a life
expectancy of > 5 years for that malignancy are eligible.
- Patients with uncontrolled infection.
- No prior autologous or allogeneic hematopoietic cell transplantation.
- 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 µg/kg of body weight.
- Virology testing including CMV, HIV, EBV, HTLV, RPR, Hepatitis A, B and C will be
performed within 30 days of donation.
- 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 donor has been
disease-free for five years
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study