Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
Completed · Phase 1
Conditions studied: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma
In brief
Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.
Key facts
- Study ID
- NCT00017472
- Run by
- National Cancer Institute (NCI)
- People needed
- 35
- Starts
- 2001-04-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- One of the following diagnoses:
- Histologically confirmed chronic lymphocytic leukemia (CLL) or non-contiguous stage II or stage III-IV small lymphocytic lymphoma (SLL)
- Previously treated with at least 1 form of chemotherapy or immunotherapy
- Histologically confirmed acute lymphoblastic leukemia (enrolled after the maximum tolerated dose (MTD) is determined)
- Must have failed 1 prior therapy
- Ineligible for allogeneic stem cell transplantation
- Histologically confirmed acute myeloid leukemia (enrolled after the MTD is determined)
- Primary refractory or relapsed (within the past year) disease
- Ineligible for potential curative therapy
- Express Hu1D10 antigen
- Greater than 2 times the mean fluorescence intensity of the control by flow cytometry (blood or bone marrow cells) OR
- Positive by immunohistochemical staining (lymph node)
- Presenting with one of the following indications for treatment unless early bone marrow transplantation is planned (CLL or SLL patients only):
- Disease-related progressive symptoms
- Progressively worsening anemia or thrombocytopenia
- Progressively worsening lymphadenopathy
- Massive splenomegaly or hypersplenism
- Hyperlymphocytosis (WBC greater than 200,000/mm3) or lymphocyte doubling time less than 12 months
- Marrow failure secondary to marrow infiltration by leukemia or lymphoma
- Performance status - ECOG 0-2
- At least 2 years
- See Disease Characteristics
- Platelet count at least 50,000/mm\^3 (without transfusion)
- Bilirubin no greater than 3 mg/dL (unless elevated secondary to tumor)
- Creatinine no greater than 2.0 mg/dL
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.