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Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies

Complete title: A Phase I Study Evaluating Escalating Doses of 90Y-BC8-DOTA (anti-CD45) Antibody followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies

Research Study Number       2361.00
Principal Investigator       Ajay Gopal, MD
Phase       I

Look up trial at NIH

Research Study Description

This phase I trial studies the side effects and best dose of monoclonal antibody therapy before stem cell transplant in treating patients with relapsed or refractory lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium- 90 anti-CD45 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving radiolabeled monoclonal antibody before a stem cell transplant may be an effective treatment for relapsed or refractory lymphoid malignancies.

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

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Patients must have a histologically confirmed diagnosis of B-NHL, T-NHL, or HL; only patients with classical HL must have documented histologic demonstration of CD45+ cells adjacent to the Reed Sternberg cells; patients must have received at least one prior standard systemic therapy with documented recurrent or refractory disease; patients with mantle cell lymphoma (MCL), T-NHL, or other high-risk malignancies may be enrolled/transplanted in complete remission (CR)/first partial remission (PR1)

- Creatinine < 2.0

- Bilirubin < 1.5 mg/dL

- All patients eligible for therapeutic study must have a minimum of >= 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 are preferred to have either a tumor mass amenable to core needle biopsy during the dosimetry phase, or a measurable tumor mass with at least one site of involvement measuring 2.5 cm in largest dimension on computed tomography (CT) imaging for purposes of planar and/or single-photon emission computed tomography (SPECT)/CT tumor dosimetry

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Circulating human anti-mouse antibody (HAMA), to be determined before each infusion

- Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled therapy dose with the exception of rituximab

- Inability to understand or give an informed consent

- Lymphoma involving the central nervous system

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

- Known human immunodeficiency virus (HIV) seropositivity

- Pregnancy or breast feeding

- Prior allogeneic bone marrow or stem cell transplant

- Prior autologous bone marrow or stem cell transplant within 1 year of enrollment

- Prior radiation therapy (RT) > 20 Gray (Gy) to a critical organ within 1 year of enrollment

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

- Patients with relapsed diffuse large B-cell lymphoma (DLBCL) or HL that have achieved a positron emission tomography (PET)-negative CR following first salvage chemotherapy

Other exclusion criteria may apply.

Research Study Number       2361.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Hematologic Malignancies; Lymphoma; Lymphoma, Non-Hodgkin (NHL)

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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