Status:
COMPLETED
A-dmDT390-bisFv(UCHT1) Immunotoxin Therapy for Patients With Cutaneous T-Cell Lymphoma (CTCL)
Lead Sponsor:
Angimmune LLC
Collaborating Sponsors:
James Graham Brown Cancer Center
M.D. Anderson Cancer Center
Conditions:
T-cell Lymphomas
T-cell Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II clinical trial aimed at treating a subgroup of patients with cutaneous T-cell lymphoma. The drug consists of a toxin, called diphtheria toxin, which is attached to an antibody that ...
Detailed Description
The purpose of this study is to further evaluate the clinical responses including response rate and duration and correlate with patient disease stage, tumor burden, anti-DT titer and degree of T cell ...
Eligibility Criteria
Inclusion
- Patients must have signed the current Institutional Review Board (IRB) approved informed consent prior to registration (see Informed Consent).
- All patients must have CTCL diagnosed by morphologic, histochemical or cell surface marker criteria with stage never exceeding IB / IIB disease and mSWAT \< 50%. CTCL patients with stage IA disease are not eligible for enrollment. CTCL patients with stage IB disease are eligible provided that they have failed a systemic treatment (this includes radiation). CTCL patients with bone marrow involvement but without lymph node involvement are eligible. Patients with a diagnosis of angioimmunoblastic T cell lymphoma are eligible, even with lymph node involvement. Age ≥ 18 years. Patients must have a performance status of \< 2 on Eastern Cooperative Oncology Group scale (see Appendix). Patients must have fully recovered from toxicity of prior chemotherapy or radiation therapy.
- Patients must have bilirubin \< 1.5 mg/dL, transaminases \< 2.5 X ULN, albumin \> 3 gm/dL, creatinine \< 2.0 mg/dL. Patients who have had albumin \< 3 gm/dL boosted by an albumin infusion must be observed to maintain albumin at \> 3gm dL for 30 days without an additional infusion.
- Patients must have a normal echocardiogram (EF \> 50% normal) without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis. The Sponsor must be provided with copies of these tests BEFORE Sponsor will approve enrollment. In addition, the sponsor must receive a list of current medications taken by the patient before Sponsor will approve enrollment.
- Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.
Exclusion
- Failure to meet any of the criteria set forth in Section 3.1.
- Inability to give informed consent because of psychiatric problems, or complicated medical problems.
- Allergic to diphtheria toxin a component of the study drug A-dmDT390-bisFv(UCHT1).
- Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC), hepatic cirrhosis, or chronic kidney disease.
- CNS leukemia.
- Preexisting cardiovascular disease. The only exception being well controlled essential hypertension with a sitting blood pressure (B.P.) of \< 160 systolic and \< 90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction \> 8 months ago. A past history of any of the following conditions is considered as exclusions to study participation:
- Congestive heart failure,
- Atrial fibrillation,
- Pulmonary hypertension,
- Anticoagulant drug therapy,
- Thromboembolic events,
- Cardiomyopathy or a myocardial infarction within the past 8 months.
- The PI and the Clinical Coordinator will be asked to verify that their referred patients do not have these exclusionary histories listed in 3.2 and a copy of this verification must be sent to the Sponsor before the Sponsor will approve of enrollment. Referring physicians will not need to sign. (Template for verification letter Appendix C).
- Pregnant or nursing women will be excluded from study.
- History of cirrhosis of the liver based on the Child-Pugh score of Class B or C are not eligible to participate. (Appendix B.)
- Prior treatment with alemtuzumab (Campath) or similar agents or procedures that depress blood T cell counts to below 50% of the lower limit of normal.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00611208
Start Date
January 1 2008
End Date
November 1 2016
Last Update
November 29 2016
Active Locations (5)
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1
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06520
2
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
3
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8562
4
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030