Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT

Not Recruiting

Trial ID: NCT00482053

Purpose

The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional transplantation regimen.

Official Title

A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation & Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation

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)

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 diffuse large B-cell lymphoma (DLBCL) by the World Health
   Organization (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 postive by fluorodeoxyglucose (FDG)-positron emission tomography
   (PET) (FDG-PET).

   - 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.

   - Eastern Cooperative Oncology Group (ECOG) performance status < 2

   - Matched related or unrelated donor identified and available

   - Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration

   - Pretreatment serum bilirubin < 2 x the institutional upper limit of normal (ULN)

   - Serum creatinine < 2 x the institutional ULN and measured or estimated creatinine
   clearance > 60 mL/min by the following formula (all tests must be performed within 28
   days prior to registration):

      - Estimated Creatinine Clearance = (140 age) x weight (kg) x 0.85 if female 72 x
      serum creatinine (mg/dL).

   - EKG within 42 days prior to registration with no significant abnormalities suggestive
   of active cardiac disease

   - 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.

   - Corrected diffusion capacity > 55%.

   - Sexually active males are advised to use an accepted and effective method of birth
   control

   - Women of child-bearing potential are advised to use an accepted and effective method
   of birth control

   - Patients must sign and give written informed consent in accordance with institutional
   and federal guidelines. Patients must be informed of the investigational nature of
   this study.

EXCLUSION CRITERIA

   - Known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with
   cyclophosphamide

   - Greater than Grade 2 sensory or motor peripheral neuropathy from prior vinca alkaloid
   use

   - Requiring therapy for coronary artery disease, cardiomyopathy, dysrhythmia, or
   congestive heart failure

   - Known to be human immunodeficiency virus (HIV)-positive. The antibody test for HIV
   must be performed within 42 days of registration.

   - Prior chemotherapy other than corticosteroids administered within 2 weeks of the
   initiation of protocol therapy.

   - Prior malignancy, 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.

   - Prior diagnosis of non-Hodgkin's lymphoma

   - Active infection requiring oral or intravenous antibiotics

   - Prior autologous or allogeneic hematopoietic cell transplantation

   - Prior radioimmunotherapy

   - Pregnant

   - Lactating

DONOR ELIGIBILITY

   - 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 HIV; cytomegalovirus (CMV); Epstein-Barr virus (EBV); human
   T-lymphotropic virus (HTLV); rapid plasma reagin (RPR); Hepatitis A, B and C be
   performed within 30 days of donation.

   - Prospective donors will be screened for CMV seroreactivity and seronegative donors
   will be utilized if available.

   - If more than one human leukocyte antigen (HLA)-matched related donor exists, then the
   donor will be selected on the basis of CD31 allotype.

Intervention(s):

procedure: Total lymphoid irradiation (TLI)

drug: Anti-thymocyte globulin (ATG)

procedure: Autologous hematopoietic stem cell transplantation (auto-HSCT)

procedure: Allogeneic hematopoietic stem cell transplantation (allo-HSCT)

drug: Rituximab

drug: Carmustine

drug: Etoposide

drug: Filgrastim

drug: Cyclosporine

drug: Mycophenolate mofetil (MMF)

drug: Cyclophosphamide

drug: Acetaminophen

drug: Diphenhydramine

drug: Hydrocortisone

drug: Methylprednisolone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822

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