Status:
COMPLETED
A Pilot Study of the Safety and Activity of Escalating Doses of ON 01910.Na in Patients With Relapsed Mantle Cell Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia, and Related Lymphoid Malignancies
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Lymphoma, Mantle-cell
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
Background: * Mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and other lymphoid malignancies are all incurable lymphoid malignancies that mainly affect persons...
Detailed Description
Mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and the related lymphoid malignancies included in this protocol are all incurable lymphoid malignancies that mainl...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Histologically documented or cytologically confirmed diagnosis of Mantle Cell Lymphoma (MCL) and refractory to, or relapsed after, greater than or equal to 1 prior lines of antineoplastic therapy (including an anthracycline or mitoxantrone and rituximab, each in one or more lines).
- OR
- Histologically documented or cytologically confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), or Prolymphocytic Lymphoma (PLL) and refractory to, or relapsed after, greater than or equal to 1 prior lines of antineoplastic therapy (including either a nucleoside analogue or an alkylating agent or a combination thereof. Must have relapsed after, failed or opted not to receive rituximab or alemtuzumab. Not a candidate for or opted not to participate in bone marrow transplantation.
- OR
- Histologically documented or cytologically confirmed diagnosis of Multiple Myeloma (MM) and refractory to, or relapsed after greater than or equal to 2 prior lines of antineoplastic therapy including both bortezomib and an immunomodulatory (IMiD) agent such as lenalidomide or thalidomide.
- OR
- Histologically documented or cytologically confirmed diagnosis of Waldenstrom s macroglobulinemia (WM) or Hairy Cell Leukemia (HCL) and refractory to, or relapsed after greater than or equal to 1 line of antineoplastic therapy.
- Measurable disease (defined as two dimensional disease on imaging or quantifiable leukemic disease or monoclonal paraproteins).
- Failed to respond to, relapsed following, not eligible for, or opted not to participate in other standard of care treatment options.
- Age greater than or equal to 18 and less than or equal to 99.
- EXCLUSION CRITERIA:
- Less than 4 weeks since having received any other treatments directed toward their malignancy (standard or investigational). Steroids permissible up to 2 weeks prior to enrollment.
- Malignant disease other than MCL, CLL/SLL, PLL, WM, HCL or MM requiring treatment with cytotoxic therapy.
- Active infection not adequately responding to appropriate therapy.
- HIV positive patients and taking anti-retroviral therapy.
- Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient s ability to tolerate protocol therapy.
- Symptomatic congestive heart failure, unstable angina pectoris, history of life threatening cardiac arrhythmia, myocardial infarction within 6 months or new conduction abnormalities by EKG. Patients with symptoms of coronary artery disease or EKG abnormalities must be evaluated and cleared by cardiology prior to enrollment.
- Uncontrolled hypertension (defined as systolic pressure greater than or equal to 160 and/or diastolic pressure greater than or equal to 110).
- New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures.
- ECOG performance status 3 or 4.
- Life expectancy less than 3 months.
- Absolute neutrophil count (ANC) less than 500.
- Platelet count less than 25,000 micro/L, unless responsive to platelet transfusion so that count can be maintained greater than 10,000 micro/L.
- Total bilirubin greater than or equal to 1.5 mg/dL not related to hemolysis or Gilbert s disease, ALT or AST greater than or equal to 2 times ULN.
- Serum creatinine greater than 1.5 times ULN or a calculated creatinine clearance of less than 40 mL/min/1.73 m(2).
- Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of less than 134 meq/L).
- Current pregnancy, unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential or currently breastfeeding.
- Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol.
- Major surgery within 3 weeks of ON 01910.Na treatment initiation
- Psychiatric illness/social situations that would limit the patient s ability to tolerate and/or comply with study requirements.
- Unable to understand the investigational nature of the study or give informed consent.
Exclusion
Key Trial Info
Start Date :
March 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00861510
Start Date
March 5 2009
End Date
October 19 2012
Last Update
December 3 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892