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.

Lead Sponsor:

Stanford University

Intervention(s):

  • 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

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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
   guidelines.

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.

   - 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.

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 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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822