Combination Chemotherapy and Denileukin Diftitox in Treating Patients With Newly Diagnosed T-Cell Non-Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00513188
Recruitment Status : Withdrawn
First Posted : August 8, 2007
Last Update Posted : December 15, 2016
Information provided by (Responsible Party):
University of Miami

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to non-Hodgkin lymphoma cells. Giving combination chemotherapy together with denileukin diftitox may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with denileukin diftitox works in treating patients with newly diagnosed T-cell non-Hodgkin lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: denileukin diftitox Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: methotrexate Drug: prednisone Drug: vincristine sulfate Genetic: protein expression analysis Other: flow cytometry Other: laboratory biomarker analysis Not Applicable

Detailed Description:



  • To evaluate failure-free survival of patients with newly diagnosed peripheral T-cell non-Hodgkin lymphoma treated with cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone (CHOP), and denileukin diftitox (Ontak®) alternating with high-dose methotrexate, leucovorin calcium, cytarabine, and Ontak® (CHOP-MONTAK regimen).


  • To determine the response rate (CR, CRu, and PR) in these patients.
  • To determine the overall survival of these patients.
  • To determine the toxicity profile of this regimen.
  • To correlate response with CD25 expression in these patients.


  • Courses 1, 3, and 5: Patients receive cyclophosphamide IV over 30 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1; oral prednisone once daily on days 1-5; and denileukin diftitox IV over 60 minutes on days 1 and 2. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Courses 2, 4, and 6: Patients receive high-dose methotrexate (MTX) IV over 24 hours on day 1; cytarabine IV over 2 hours every 12 hours on days 2 and 3; and leucovorin calcium IV over 15 minutes every 6 hours for 8 doses beginning 12 hours after the last dose of each MTX infusion. Patients also receive denileukin diftitox IV over 60 minutes for 2 doses once MTX blood levels have cleared. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Samples are analyzed for CD25-positive or -negative expression and response rate via flow cytometry.

After completion of study treatment, patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: A Pilot Study of the Efficacy of the Chop-Montak Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
Study Start Date : February 2007
Actual Primary Completion Date : June 2008

Primary Outcome Measures :
  1. Failure-free survival

Secondary Outcome Measures :
  1. Response rate (CR, CRu, and PR)
  2. Overall survival
  3. Toxicity profile
  4. Correlation of response with CD25 expression

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Confirmed diagnosis of peripheral T-cell non-Hodgkin lymphoma

    • Newly diagnosed, previously untreated disease
    • Mycosis fungoides with systemic disease (i.e., beyond the skin) allowed
  • No CD30-positive ALK 1-positive T-anaplastic large cell lymphoma
  • No skin only involvement
  • No localized NK/T-cell lymphoma
  • No adult T-cell leukemia/lymphoma
  • No known CNS involvement


  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC > 1,000/mm^3 (unless due to lymphoma)
  • Platelets > 100,000/mm^3 (unless due to lymphoma)
  • Serum bilirubin ≤ 2.0 mg/dL (unless due to lymphoma)
  • Serum creatinine ≤ 1.5 mg/dL (unless due to lymphoma)
  • Albumin ≥ 3.0 g/dL
  • Cardiac ejection fraction ≥ 50% by MUGA or echocardiogram
  • Not pregnant or nursing
  • Negative serum or urine β-HCG at screening
  • Women and male partners of child-bearing potential must practice an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before study entry and throughout the study period
  • Willing to receive transfusions of blood products
  • No HIV-positive serology
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Child's class C liver cirrhosis
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situations that would limit study compliance
  • No other prior or concurrent malignancy with a poor prognosis (i.e., < 90% probability of survival at 5 years) or that is actively being treated


  • No prior chemotherapy for the treatment of lymphoma
  • No other concurrent investigational agents for the treatment of lymphoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00513188

United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Study Chair: Maricer Escalon, MD, MS University of Miami Sylvester Comprehensive Cancer Center

Responsible Party: University of Miami Identifier: NCT00513188     History of Changes
Other Study ID Numbers: 20060912
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016

Keywords provided by University of Miami:
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
adult nasal type extranodal NK/T-cell lymphoma
stage IV mycosis fungoides/Sezary syndrome
stage IV cutaneous T-cell non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma, T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Liposomal doxorubicin
Denileukin diftitox
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors