Trial Search Results

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)

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Institutes of Health (NIH)

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 2

Eligibility


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.

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 intravenous 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 µg/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.

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
BMT Referrals
6507230822
Not Recruiting