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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|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Patients must have a histologically confirmed diagnosis of B-NHL, T-NHL, or HL; CD45 antigen expression must be documented on tumor specimens in all cases except HL, in whom histologic demonstration of CD45+ cells adjacent to the Reed Sternberg cells is required; 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 x10^6 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)
- 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.
Hematologic Malignancies; Lymphoma; Non-Hodgkin's Lymphoma (NHL)
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