SAR650984 for CD38+ Hematological Malignancies
Dose Escalation Safety and Pharmacokinetic Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 In Patients With Selected CD38+ Hematological Malignancies
|Recruiting||Hematological Malignancies||Phase II||NCT01084252|
- To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984
- To characterize the global safety profile including cumulative toxicities
- To evaluate the pharmacokinetic (PK) profile of SAR650984 in the proposed dosing schedule(s)
- To assess the pharmacodynamics, immune response, and preliminary disease response
Eligibility Criteria (must meet the following to participate in this study)
- Patients with confirmed selected CD38+ hematological malignancies as specified below who have progressed on after standard therapy or for whom there is no effective standard therapy (refractory/relapsed patients).
- B-cell Non-Hodgkin-lymphoma/leukemia (NHL) patients having at least 1 measurable lesion
- Multiple myeloma (MM) patients with measurable M-protein serum and/or 24-hour urine
- Acute myeloid leukemia (AML) patients, all types except M3 based on French-American-British (FAB) classification
- Acute Lymphoblastic Leukemia (B-cell ALL) patient
- Chronic lymphocytic leukemia (CLL) patients
Exclusions (conditions that would prevent participation in this study)
- Karnofsky performance status <60
- Poor bone marrow reserve
- Poor organ function
- Known intolerance/hypersensitivity to infused protein products
- Any serious active disease (including clinically significant infection that is chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results
- Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Last UpdatedOctober 14, 2015
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.
- 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.