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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Peripheral T-Cell Lymphoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

UC-PTCL-ONTAK

NCT ID:

NCT00632827

Start Date:

June 2008

Completion Date:

June 2013

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location

Washington UniversitySt. Louis, Missouri  63110
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Weill Cornell Medical CollegeNew York, New York  10021