Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma
A Phase II Study Evaluating the Safety and Effectiveness of ABT-510 in Subjects With Refractory Lymphoma
1 other identifier
interventional
67
1 country
14
Brief Summary
The primary objective of this study is to assess the safety and effectiveness of ABT-510 in subjects with refractory lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 2, 2003
CompletedFirst Posted
Study publicly available on registry
June 4, 2003
CompletedAugust 15, 2007
August 1, 2007
June 2, 2003
August 13, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate
One year
Secondary Outcomes (3)
Progression free survival
One year
Overall survival
One year
Performance status
One year
Interventions
Eligibility Criteria
You may qualify if:
- A subject will be eligible for study participation if all of the following criteria are met:
- 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 0-2.
- The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
- 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 procedures.
You may not qualify if:
- A subject will be ineligible for study participation if any of the following criteria are met:
- 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 CNS metastases.
- 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 drug administration.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (14)
Hematology Oncology Associates
Phoenix, Arizona, 85012, United States
Arizona Clinical Research Center
Tucson, Arizona, 85712, United States
USC - Norris Cancer Center
Los Angeles, California, 90033, United States
The Center for Hematology-Oncology
Boca Raton, Florida, 33486, United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176, United States
Cancer Centers of Florida, P.A.
Orlando, Florida, 32806, United States
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64111, United States
Arch Medical Services, INC.
St Louis, Missouri, 63142, United States
Albany Regional Cancer Center
Albany, New York, 12208, United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, 27511, United States
The West Cancer Clinic
Memphis, Tennessee, 38120, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Hematology Oncology Associates
San Antonio, Texas, 78229, United States
U of W - Comprehensive Care Center
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rod Humerickhouse, MD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 2, 2003
First Posted
June 4, 2003
Study Start
April 1, 2003
Last Updated
August 15, 2007
Record last verified: 2007-08