Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma

Not Recruiting

Trial ID: NCT00481832

Purpose

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.

Official Title

Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma

Stanford Investigator(s)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

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

Intervention(s):

drug: Cyclophosphamide

drug: Etoposide

drug: Filgrastim

drug: Mycophenolate mofetil

drug: Antithymocyte globulin

drug: Cyclosporine

drug: rituximab

drug: BCNU

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

Not Recruiting

Contact Information

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

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