RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous 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: NCT00667017
Recruitment Status : Terminated (Slow accrual.)
First Posted : April 25, 2008
Results First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin IMTOX25), can find certain cancer cells and kill them without harming normal cells.

PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25 and how well it works in treating patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: RFT5-dgA immunotoxin Other: fluorescence activated cell sorting Other: immunohistochemistry staining method Phase 2

Detailed Description:



  • Determine the response rate of patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma (CTCL) following treatment with RFT5-dgA immunotoxin (anti-CD25 immunotoxin IMTOX25) .


  • Determine whether responses correlate with the level of CD25+ expression on the CTCL tumor cells.
  • Determine whether changes in the pre-treatment and the post-treatment levels of CD4+CD25+ Treg cells correlate with responses.

OUTLINE: Patients receive anti-CD25 immunotoxin IMTOX25 IV over 4 hours on days 1, 3, and 5. Treatment repeats every 6 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Tissue and blood samples are collected at baseline, and during study for CD25+ expression by fluorescent-activated cell sorter analysis, immunohistochemistry.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
Actual Study Start Date : November 7, 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: IMTOX25 at 2mg/m²/dose
Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.
Biological: RFT5-dgA immunotoxin
Other: fluorescence activated cell sorting
Other: immunohistochemistry staining method

Primary Outcome Measures :
  1. Response Rate - Cutaneous T Cell Lymphoma (CTCL) [ Time Frame: Once a week for seven weeks ]
    Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed cutaneous T-cell non-Hodgkin lymphoma (CTCL)
  • Relapsed or refractory disease, meeting 1 of the following criteria:

    • Progression of disease following 2 prior chemotherapies
    • Failure to respond to the second prior chemotherapy
  • Measurable disease


  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Serum creatinine < 1.5 times upper limit of normal (ULN)
  • Serum AST/ALT < 2.5 times ULN
  • Total bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL in patients with Gilbert syndrome)
  • WBC count ≥ 3,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum albumin > 2.5 g/dL
  • LVEF ≥ 45% by 2-D ECHO or MUGA scan
  • Human antimurine antibody < 1 μg/mL
  • Patients with a history of electrocardiogram abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test (i.e., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test)
  • Must be willing to undergo venipuncture and central line placement
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HBV surface antigen, HCV, or HIV antibody positivity
  • No autoimmune disease or immunodeficiency (i.e., HIV)
  • No history of uncontrolled concurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Ongoing or active cardiac disease (i.e., congestive heart failure, unstable angina pectoris, or cardiac arrhythmia)
    • Psychiatric illness and/or social situation that would preclude study compliance
  • No other malignancies except treated basal cell or squamous cell carcinoma of the skin, or treated carcinoma in situ of the cervix


  • See Disease Characteristics
  • More than 3 weeks since prior systemic therapy for CTCL
  • More than 6 months since prior chronic steroid therapy or chronic anti-coagulation therapy
  • No prior therapy with anti-CD25 immunotoxin IMTOX25 and/or Ontak
  • No other concurrent cancer chemotherapy, experimental therapy, investigational agent, or immunomodulating agent (including steroids)

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): NCT00667017

United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Simrit Parmar, MD Simmons Cancer Center

Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT00667017     History of Changes
Other Study ID Numbers: SCCC-02407
CDR0000594170 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 25, 2008    Key Record Dates
Results First Posted: December 14, 2018
Last Update Posted: December 14, 2018
Last Verified: November 2018

Keywords provided by University of Texas Southwestern Medical Center:
recurrent mycosis fungoides/Sezary syndrome
recurrent cutaneous T-cell non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs