A Phase II Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma
A subject will be eligible for study participation if all of the following criteria are
- The subject is at least 18 years of age.
- The subject has histologically confirmed non-Hodgkin's Lymphoma (NHL) (excluding
Burkitt's, Burkitt's type or HIV associated lymphoma) or Hodgkin's Lymphoma (HL) that
is refractory to or has relapsed after standard therapy or for which there is no
known effective treatment.
- The subject must have measurable disease by the CHESON Criteria for Tumor Response.
- The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of
- The subject is able to self-administer or has a caregiver who can reliably administer
- The subject must have adequate bone marrow, renal and hepatic function as follows:
- Bone marrow: *White blood cell count (WBC) greater than or equal to 3,000/mm3;
*Platelets greater than or equal to 75,000/mm3 unless subject has received a
prior transplant or bone marrow involvement with lymphoma has been documented,
then platelets of equal to or greater than 50,000 is acceptable. *Hemoglobin
greater than or equal to 8.5 g/dL; *ANC greater than or equal to 1000/mm3
- Renal function: *Serum creatinine less than or equal to 2.0 mg/dL
- Hepatic function: *AST and ALT less than or equal to 3.0 X ULN
- The subject must not be pregnant or lactating and all subjects (male and female) must
use a contraceptive method deemed appropriate by the investigator while in the study
and up to two months following completion of therapy.
- The subject has voluntarily signed and dated an Institutional Review Board
(IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific
A subject will be ineligible for study participation if any of the following criteria are
- The subject has a history of or currently exhibits Central Nervous System (CNS)
metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of
- The subject is receiving therapeutic anticoagulation therapy. Low dose
anticoagulation (e.g., low dose Coumadin) for catheter prophylaxis is permitted;
PT/PTT must be within normal limits.
- The subject has a history of or currently exhibits clinically significant cancer
related events of bleeding (e.g., hemoptysis). The subject has a recent history of
(within 4 weeks of Study Day 1) or currently exhibits other clinically significant
events of bleeding.
- The subject has received any therapy for lymphoma including chemotherapy, antibody
therapy, radiotherapy or any investigational therapy within four weeks prior to study
- The subject has been initiated on steroids or there is an increase in current steroid
dose within three months prior to study drug administration.
- The subject exhibits evidence of clinically significant uncontrolled condition(s)
and/or is considered by the investigator to be unable to tolerate the proposed
treatment or procedures.
- The subject has history of other previous malignancies within 5 years, with the
exception of: Adequately treated in situ carcinoma of the cervix; Basal or squamous
cell carcinoma of the skin.