Status:
TERMINATED
Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Gilead Sciences
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability to administer safely 2 ...
Detailed Description
The treatment regimen consists of 2 elements. The first element is represented by one courses of veltuzumab (4 weekly injections of 200 mg/m2). 90Y-epratuzumab will be given as 2 injections at escalat...
Eligibility Criteria
Inclusion
- Male or female, \>18 years old
- Histological diagnosis of CD20+ Follicular lymphoma by WHO lymphoma criteria.
- FLIPI intermediate or high risk (2-5 risk factors)
- No prior systemic treatment for NHL
- Measurable disease by CT, with at least one lesion \>1.5 cm in one dimension
- Life expectancy of at least 6 months
- ECOG performance status \> = 2
- Patients must have normal organ and marrow function as defined below:
- ANC \> = 1,500/uL
- platelets \> = 100,000/uL
- total bilirubin \< = 1.5 x upper limit of normal
- AST(SGOT)/ALT(SGPT) \< = 2.5 X upper limit of normal
- creatinine \< = 1.5 x upper limit of normal
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test
- Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last weekly veltuzumab infusion.
- Primary CNS lymphoma, HIV lymphoma or transformed lymphoma, or presence of symptomatic CNS metastases or carcinomatous meningitis.
- Bulky disease by CT, defined as any single mass \>10 cm in its greatest diameter
- Disease status eligible for potentially curative external beam radiation (stage 1 or contiguous stage 2 at sites appropriate for radiotherapy)
- Bone marrow involvement ≥25%; patients with CLL
- Pleural effusion with positive cytology for lymphoma
- Patients known to be HIV positive or hepatitis B positive
- Corticosteroid use within 2 weeks, unless 20 mg/day or less at stable dose.
- Prior malignancy with less than a 1-year disease-free interval, excluding non-melanoma skin cancers and carcinoma in situ of the cervix.
- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01147393
Start Date
October 1 2010
End Date
July 31 2015
Last Update
February 22 2018
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10065