Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Trial ID or NCT#

NCT00186628

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 76 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Laura Johnston
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Robert Negrin
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sally Arai
Sally Arai
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Richard Hoppe
Richard Hoppe
Radiation oncologist
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Judith Shizuru
Judith Shizuru
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist, Hematologist-Oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Contact us to find out if this trial is right for you.

Contact

Kate Tierney
6507257063

View on ClinicalTrials.gov