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Clinical Trial Detail

Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies

Complete title: Evaluation of Pretargeted anti-CD20 Radioimmunotherapy Combined with BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk B-cell Malignancies

Research Study Number 9189
Principal Investigator Ajay Gopal, MD
Phase I

Research Study Description

This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating patients with B-cell malignancies that have not responded to treatment or have come back after responding to treatment. CD20 is a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches radioactive material to a drug that is designed to target CD20, which brings radioactive material to the cancer cells to kill the cells. This may kill more tumor cells while causing fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell transplant may be more effective in treating patients with B-cell malignancies.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- Patients must have a histologically confirmed diagnosis of lymphoma expressing the CD20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) as well as other select high-risk lymphomas (e.g., Burkitt's, double hit diffuse large B-cell lymphoma [DLBCL], transformed indolent B-cell non-Hodgkin lymphoma [B-NHL], etc.) in accordance with current transplant standard of care for these patients

- Creatinine (Cr) < 2.0

- Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5 mg/dL

- All patients eligible for therapeutic study must have (>= 2 x 10^6 CD34/kg) autologous hematopoietic stem cells harvested and cryopreserved

- Patients must have an expected survival of > 60 days and must be free of major infection

- Patients of childbearing potential must agree to abstinence or the use of effective contraception

- DONOR SELECTION: Not applicable; this protocol employs autologous transplantation, utilizing the patient's own hematopoietic stem cells obtained from either the peripheral blood or bone marrow

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled 90Y therapy dose

- Inability to understand or give an informed consent

- Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, both kidneys) within 1 year of the treatment date

- Active central nervous system lymphoma

- Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide [DLCO] < 50% predicted, patient on supplemental oxygen, acquired immune deficiency syndrome [AIDS], etc.)

- Pregnancy or breast feeding

- Prior bone marrow or stem cell transplant

- Southwest Oncology Group (SWOG) performance status >= 2.0

- Known sensitivity to kanamycin and other aminoglycosides; patients with known hypersensitivity to kanamycin or any other aminoglycoside antibiotic will be excluded

Other exclusion criteria may apply.

Research Study Number 9189
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Lymphoma, Burkitt; Hematologic Malignancies; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Non-Hodgkin (NHL); Immunoproliferative Disorders; Lymphoma, Mantle-Cell; Virus Diseases; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Epstein-Barr Virus Infections; Herpesviridae Infections; Immune System Diseases; Lymphoma, B-Cell Non-Hodgkin; DNA Virus Infections; Tumor Virus Infections

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