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

To determine if Rituximab administered after allogeneic transplantation decreases the incidence of chronic GvHD

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Cixutumumab
  • drug : Paclitaxel
  • procedure : nonmyeloablative allogeneic hematopoietic cell transplant

Phase: Phase 2

Eligibility

Ages Eligible For Study:

17 Years - 76 Years

Inclusion Criteria

(A) Patients age greater than 17 and less than 76. (B) CLL patients with unmutated IgG VH gene status are immediately eligible and patients with mutated IgG VH genes (>2% nucleotide change compared to somatic sequence) are eligible if they are considered appropriate by their HSCT physician. CLL patients in complete remission benefit most from allogeneic HSCT, and physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative transplantation. (C) MCL patients who their BMT physicians believe would benefit from allogeneic HSCT. (D) Adequate renal (Cr < 2.4 mg/dl) and hepatic (Bilirubin < 3.0 mg/dl, AST < 100 IU) function. Patients with lab results in excess of these can be enrolled with approval of PI. (E) 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. (F) All subjects must provided written informed consent Donor Inclusion Criteria (A) Genotypically or phenotypically HLA-identical. (B) Donor age < 75 unless cleared by institutional P.I (C) Capable of giving written, informed consent. (D) Donor must consent to PBSC mobilization with G-CSF and apheresis

External Links

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Contact information

Primary Contact:

Kate Tierney 6507257063

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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