Notice: Users may be experiencing issues with displaying some pages on stanfordhealthcare.org. We are working closely with our technical teams to resolve the issue as quickly as possible. Thank you for your patience.

COVID-19 Resources » Vaccine Update » Visitor Policy »

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

Phase II Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Trial ID or NCT#

NCT00186628

Status

NOT RECRUITING

Purpose

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

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:

- 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

View All Criteria

Investigator(s)

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

Radiation oncologist

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

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)

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

Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Lowsky

Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

CONTACT

Kate Tierney
(650) 725-7063

SEND MESSAGE

View on ClinicalTrials.gov

New to MyHealth?

ALREADY HAVE AN ACCESS CODE?

DON'T HAVE AN ACCESS CODE?

NEED MORE DETAILS?

MyHealth for Mobile

Phase II Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To:

New to MyHealth?

ALREADY HAVE AN ACCESS CODE?

DON'T HAVE AN ACCESS CODE?

NEED MORE DETAILS?

MyHealth for Mobile

WELCOME BACK

Phase II Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

About this Clinical Trial

Your Message Will Go To

To: