Status:
TERMINATED
Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eisai Inc.
Washington University School of Medicine
Conditions:
Peripheral T-Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study examines the use of denileukin diftitox (Ontak) for patients with peripheral T-cell lymphoma who are candidates for autologous stem cell transplants.
Detailed Description
This protocol proposes first to increase the proportion of patients who achieve adequate initial disease control and are able to proceed to autologous stem cell transplant (ASCT) in first complete or ...
Eligibility Criteria
Inclusion
- Histologic diagnosis of any of the following:
- Peripheral T-cell lymphoma not otherwise specified (PTCL-U),(IPI \>2)
- Angioimmunoblastic T-cell lymphoma (AILT) (IPI \>2)
- Non-primary cutaneous Alk-1-negative anaplastic large cell lymphoma
- Extranodal natural killer (NK)/T lymphoma (Excluding stage I/II nasal disease)
- Blastic NK cell lymphoma
- Enteropathy type T-cell lymphoma
- Cutaneous panniculitis-like T-cell lymphoma
- Hepatosplenic T-cell lymphoma
- Measurable or assessable disease is not required.
- Age ≥ 18 and ≤ 70 years
- Previously untreated or 1 prior cycle of chemotherapy
- Creatinine \< 2.0 mg/dL
- Total bilirubin \< 2.0 mg/dL, aspartate aminotransferase (AST) \< 3x upper limit of normal
- Patients who test positive for Hepatitis B surface Ag (HepBSAg) or Hepatitis C antibody (HepCAb) are eligible provided all of the following criteria are met:
- bilirubin ≤ 2 x upper limit of normal;
- aspartate aminotransferase (AST) ≤ 3 x upper limit of normal;
- liver biopsy demonstrates ≤ grade 2 fibrosis and no cirrhosis.
- Hepatitis B surface Ag(+) patients will be treated with lamivudine (3TC) or investigator's preferred antiviral regimen throughout protocol therapy and for 6-12 months thereafter.
- Neutrophils ≥ 1000/microlitre (uL) platelets \> 100,000/uL
- HIV-negative
- Left ventricular ejection fraction (LVEF) of ≥ 45%
- No known hypersensitivity to denileukin diftitox or any of its components: diptheria toxin, interleukin-2, or excipients
- Non-pregnant, non-nursing: Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
- Patients with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible. (This includes Waldenstrom's Macroglobulinemia, since such patents have experienced transient increases inImmunoglobulin M (IgM) following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis). Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse.
Exclusion
- PTCL-U / AILT with IPI 0 or 1 Extranodal NK/T nasal stage I/II T-lymphoblastic lymphoma Adult T-cell leukemia/lymphoma
- Adult T-cell leukemia/lymphoma
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00632827
Start Date
July 1 2008
End Date
June 23 2016
Last Update
April 27 2020
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110