Clinical trial · Interventional

A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma

A Pilot Phase II Study to Determine the Safety and Efficacy of the Combination of ONTAK With CHOP in Peripheral T-Cell Lymphoma.

NCT00211185CI-TRIAL-00044112completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when compared to CHOP alone.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lymphoma, T-Cell, Peripheral	Lymphoma	ONTOLOGY_EXACT	0.85

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Denileukin diftitox	Drug	—	UNRESOLVED
Doxorubicin	Drug	Doxorubicin	ALIAS
Pegfilgrastim	Other	—	UNRESOLVED
Prednisone	Drug	Prednisone	ALIAS
Vincristine	Drug	Vincristine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Denileukin diftitox in combination with CHOP
description
Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
interventionNames
1. Drug: Denileukin diftitox
2. Drug: Cyclophosphamide
3. Drug: Doxorubicin
4. Drug: Vincristine
5. Drug: Prednisone
6. Other: Pegfilgrastim

Primary outcomes (4)

measure
Summary of All Adverse Events by Frequency in Greater Than 20% of Treated Participants
timeFrame
From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Pathological diagnosis of peripheral T-cell lymphoma of one of the following histologies as per the REAL classification: peripheral T-cell lymphoma (unspecified), anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma.
* Treatment naïve except for prior radiation or a single cycle of CHOP.
* Patients must have at least one clear-cut bidimensionally measurable site by physical exam and/or computed tomography.
* Prior radiation therapy for localized disease is allowed as long as the irradiated area is not at the mediastinal area or at the only site of measurable disease. Therapy must be completed at least 4 weeks before the enrollment in study.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* At least 18 years of age.
* Adequate bone marrow reserve, indicated by absolute neutrophil count (ANC) \> or equal to 1000/microL, platelets \> or equal to 50,000/microL (25,000/MicroL if thrombocytopenia secondary to bone marrow involvement by lymphoma), and hemoglobin \> or equal to 8 g/dL.
* Adequate liver function, indicated by bilirubin \< or equal to 1.5 times the upper limit of normal (ULN), alanine transaminase (ALT) \< or equal to 2 times the ULN or aspartate transaminase (AST) \< or equal to 2.0 times the ULN, and albumin \> or equal to 3.0 g/dL.
* Adequate renal function, indicated by serum creatinine \< or equal to 2.5 mg/dL.
* Women of childbearing potential and sexually active males agree to use an accepted and effective method of contraception.
* Able to give informed consent.

Exclusion Criteria:

* Diagnosis of Mycosis Fungoides or Sezary Syndrome.
* Active Hepatitis B or Hepatitis C infection.
* Known HIV infection (HIV testing is not required).
* Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections have resolved and any continuing treatment if appropriate is given on an outpatient basis.
* Previous doxorubicin therapy with cumulative dose of \>100 mg/m2.
* Left Ventricular Ejection Fraction (LVEF) \< 50%.
* Patients who are pregnant or breast-feeding.
* Prior invasive malignancies within past 5 years.
* Allergy to or history of allergy to diphtheria toxin or IL-2.
* Preexisting severe cardiovascular disease (e.g. CHF, Severe CAD, cardiomyopathy, MI within the past 3 months, arrhythmia) requiring ongoing treatment.
* Ongoing antineoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within past 30 days.
* Patients with deep vein thrombosis within 3 months.

References

Publications (2)

RESULTFrancine M. Foss, Nelida Sjak-Shie, Andre Goy, Ranjana Advani, Eric Jacobsen, and Mark Acosta A Phase II Study of Denileukin Diftitox (Ontak®) with CHOP Chemotherapy in Patients with Newly-Diagnosed Aggressive T-Cell Lymphomas, the CONCEPT Trial: Interim Analysis. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108: 2461.
DERIVEDFoss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leuk Lymphoma. 2013 Jul;54(7):1373-9. doi: 10.3109/10428194.2012.742521. Epub 2013 Jan 29. PMID 23278639

Registry

Dates and enrollment

Start: Mar 14, 2004
Primary completion: Aug 1, 2008
Completion: Dec 23, 2009
First posted: Sep 21, 2005
Last update posted: Mar 18, 2020
Results first posted: Mar 18, 2020
Enrollment: 49 (actual)
Lead sponsor: Eisai Inc. INDUSTRY

Data updated 22 days agoSource updated Mar 18, 2020source: clinicaltrials

Locations

Locations by country (49)

Country	Sites	Recruiting
United States	49	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.