This trial is active, not recruiting.

Condition peripheral t-cell lymphoma
Treatments regimen, regimen b
Phase phase 2
Sponsor University of California, San Francisco
Collaborator Esai Pharmaceuticals
Start date June 2008
End date December 2014
Trial size 21 participants
Trial identifier NCT00632827, UC-PTCL-ONTAK


This study examines the use of denileukin diftitox (Ontak) for patients with peripheral T-cell lymphoma who are candidates for autologous stem cell transplants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Gemcitabine/Navelbine/Doxil Days 1 and 8 G-CSF Days 4-6 and 10-15
Induction chemotherapy
Cyclophosphamide/Doxorubicin/Vincristine on Day 1 Prednisone Days 1-5 Methotrexate Day 15
regimen b
Induction Chemotherapy

Primary Outcomes

The primary endpoint of this trial is improvement in 3-year progression-free survival from 30% to 50% under the study regimen.
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Histologic diagnosis of any of the following: - Peripheral T-cell lymphoma not otherwise specified (PTCL-U),(IPI >2) - Angioimmunoblastic T-cell lymphoma (IPI >2) - Non-primary cutaneous Alk-1-negative anaplastic large cell lymphoma - Extranodal NK/T lymphoma (Excluding stage I/II nasal disease) - Blastic NK cell lymphoma - Enteropathy type T-cell lymphoma - Subcutaneous 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, AST < 3x upper limit of normal - Patients who test positive for HepBSAg or HepC Ab are eligible provided all of the following criteria are met: - bilirubin ≤ 2 x upper limit of normal; - 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 amivudine (3TC) or investigator's preferred antiviral regimen throughout protocol therapy and for 6-12 months thereafter. - Neutrophils >1000/uL platelets > 100,000/uL - Albumin > 3.0 mg/dL - HIV-negative - 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 in 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 Criteria: - PTCL-U / AILT with IPI 0 or 1 Extranodal NK/T nasal stage I/II T-lymphoblastic lymphoma Adult T-cell leukemia/lymphoma

Additional Information

Official title Treatment of Peripheral T-cell Lymphoma With Aggressive Induction Chemotherapy Followed by Autologous Stem Cell Transplant Using Denileukin Diftitox (Ontak) for In-vivo Purging and Post-Transplant Therapy: A Multicenter Phase II Clinical Trial
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 partial remission. It administers intensive and novel induction therapy. Two cycles of GND (gemcitabine, vinorelbine, Doxil) will be used followed by two cycles of augmented dose CHOP (Cyclophosphamide) plus high-dose MTX. Patients will be restaged after two cycles of GND to assess response to GND alone and again after the second cycle of augmented CHOP/high-dose MTX. Those achieving a remission status will receive intensive consolidation with HDAC/etoposide followed by stem cell mobilization. A five-day course of denileukin diftitox (Ontak) will be administered at and will serve as an in vivo purge. This will be followed by autologous stem cell transplant. Those not achieving partial remission or better following the four induction courses will receive 2 cycles of denileukin diftitox(Ontak) for 5 days. Those achieving partial remission or better to this regimen will go on to consolidation/mobilization and autologous stem cell transplant. Post-transplant, denileukin diftitox will also be used as an additional module of therapy.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.