Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Not Recruiting

Trial ID: NCT00186628

Purpose

To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)

Official Title

An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation

Stanford Investigator(s)

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


Recipient Inclusion Criteria:

   - Between 18 and 76 years of age

   - Chronic lymphocytic leukemia (CLL):

      - Unmutated IgG VH gene status

      - Mutated IgG VH genes (> 2% nucleotide change compared to somatic sequence)

      - Complete remission benefit most from allogeneic hematopoietic stem cell
      transplant (HSCT).

(Physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative
transplantation.)

   - Mantle cell lymphoma (MCL): Transplant physicians believe subject would benefit from
   allogeneic HSCT.

   - Adequate renal (Cr < 2.4 mg/dL) and hepatic (Bilirubin < 3.0 mg/dL, Aspartate
   aminotransferase (AST) < 100 IU) function.

   - Men and women of reproductive potential must agree to use an acceptable method of
   birth control during treatment and for six months after completion of treatment.

   - All subjects must provide written informed consent

Donor Inclusion Criteria:

   - Genotypically or phenotypically human leukocyte antigen (HLA)-identical.

   - Age < 76 unless cleared by institutional PI

   - Capable of giving written, informed consent.

   - Must consent to peripheral blood stem cell (PBSC) mobilization with G-CSF and
   apheresis

Recipient Exclusion Criteria:

   - Recipient has a 9 of 10 or 10 of 10 HLA identical donor (high resolution molecular
   genotyping at HLA A, B, C and DrB1, and DQ)

   - Pregnancy

   - Lactating

   - Serious uncontrolled infection

   - HIV seropositivity

   - Hepatitis B or C seropositivity

   - Cardiac function: ejection fraction < 40% or uncontrolled cardiac failure

   - Pulmonary: Diffusing capacity - carbon monoxide (DLCO) < 50% predicted

   - Liver function abnormalities: elevation of bilirubin to ≥ 3 mg/dL and/or AST > 100

   - Renal: creatinine > 2.4

   - Karnofsky performance score ≤ 60%

   - Patients with poorly controlled hypertension (systolic blood pressure > 150 or
   diastolic blood pressure > 90 repeatedly).

   - Known life-threatening hypersensitivity to rituximab or other anti-B cell antibodies.

   - Inability to comply with the allogeneic transplant treatment.

   - Uncontrolled central nervous system (CNS) involvement with disease

Donor Exclusion Criteria:

   - Identical twin to subject

   - Contra-indication to subcutaneous G-CSF at a dose of 16 mg/kg/d for 5 consecutive days

   - Serious medical or psychological illness

   - Prior malignancy within the preceding five years, with the exception of non-melanoma
   skin cancers.

   - HIV seropositivity

Intervention(s):

procedure: Total lymphoid irradiation

drug: Rituximab

drug: Anti-thymoglobulin, rabbit (ATG, rabbit ATG)

drug: Cyclosporine

drug: Mycophenylate mofetil

drug: Filgrastim

drug: Granisetron

drug: Solumedrol

drug: Acetaminophen

drug: Diphenhydramine

drug: Hydrocortisone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kate Tierney
6507257063

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