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NCT00632827 · REGISTRY CONDITION SEARCH

Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2020-04-27

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Overall Survival Rate

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outcome · POSTED

Complete Response Rate

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outcome · POSTED

Median Time to Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologic diagnosis of any of the following: * Peripheral T-cell lymphoma not otherwise specified (PTCL-U),(IPI \>2) * Angioimmunoblastic T-cell lymphoma (AILT) (IPI \>2) * Non-primary cutaneous Alk-1-negative anaplastic large cell lymphoma * Extranodal natural killer (NK)/T lymphoma (Excluding stage I/II nasal disease) * Blastic NK cell lymphoma * Enteropathy type T-cell lymphoma * Cutaneous 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, aspartate aminotransferase (AST) \< 3x upper limit of normal * Patients who test positive for Hepatitis B surface Ag (HepBSAg) or Hepatitis C antibody (HepCAb) are eligible provided all of the following criteria are met: * bilirubin ≤ 2 x upper limit of normal; * aspartate aminotransferase (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 lamivudine (3TC) or investigator's preferred antiviral regimen throughout protocol therapy and for 6-12 months thereafter. * Neutrophils ≥ 1000/microlitre (uL) platelets \> 100,000/uL * HIV-negative * Left ventricular ejection fraction (LVEF) of ≥ 45% * 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 inImmunoglobulin M (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 * Adult T-cell leukemia/lymphoma
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    (1) Induction Chemo A; Two 21-day cycles of Gemcitabine 1000 mg/m2 days (D) 1, 8, Navelbine 20 mg/m2 D1, D8; Doxil 15 mg/m2 Days 1 and 8, G-CSF Days 4-6 and 10-15 (2) Induction Chemo B: Two 21-day cycles of Cyclophosphamide 2000 mg/m2 day 1; Doxorubicin 50 mg/m2 day 1; Vincristine 1.4 mg/m2 day 1; Prednisone 100 mg/m2 days 1-5; Methotrexate 3000 mg/m2 IV over 4h day 15; Leucovorin rescue (3) Disease Evaluation (4) High-dose Consolidation Chemo, high dose Ara-C, Denileukin diftitox (Ontak) and Stem Cell Collection (5) Consolidation Cytarabine 2000 mg/m2 IV over 2 h q 12h days 1-4, Etoposide 40 mg/m2 continuous intravenous infusion (CIVI), days 1-4, Denileukin Diftitox (Ontak) 9 mcg/kg/day days 6-10, G-CSF 10 mcg/kg/day day 14+, Stem cell collection day 22 (6) Autologous Stem Cell Transplant Carmustine 550 mg/m2 day -6, Etoposide 60 mg/kg IV over 4h day -4, Cyclophosphamide 100 mg/kg day -2, Stem cell infusion D0 (7) Post-transplant: Denileukin Diftitox (Ontak) 18 mcg/kg/day days 1- 5
    intervention Names
    1. Drug: Gemcitabine
    2. Drug: Navelbine
    3. Drug: Doxorubicin Hydrochloride Liposome Injection
    4. Drug: Granulocyte-colony stimulating factor (G-CSF)
    5. Drug: Pegfilgrastim
    6. Drug: Cyclophosphamide
    7. Drug: Vincristine
    8. Drug: Leucovorin
    9. Drug: Methotrexate
    10. Drug: Doxorubicin Hydrochloride
    11. Drug: Cytarabine
    12. Drug: Etoposide
    label
    Treatment Plan
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment Plan
    description
    Chemotherapy medication used to treat a number of types of cancer
    name
    Gemcitabine
    other Names
    1. Gemzar
    type
    DRUG
  2. arm Group Labels
    1. Treatment Plan
    description
    Navelbine is an chemotherapy medication used to treat a number of types of cancer
    name
    Navelbine
    other Names
    1. Vinorelbine
    type
    DRUG
  3. arm Group Labels
    1. Treatment Plan
    description
    Doxorubicin Hydrochloride Liposome Injection is an anti-cancer chemotherapy drug
    name
    Doxorubicin Hydrochloride Liposome Injection
    other Names
    1. Doxil
    type
    DRUG
  4. arm Group Labels
    1. Treatment Plan
    description
    G-CSF is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.
    name
    Granulocyte-colony stimulating factor (G-CSF)
    other Names
    1. G-CSF
    type
    DRUG
  5. arm Group Labels
    1. Treatment Plan
    description
    Colony-stimulating factor 3 (CSF 3) and, is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. May be used instead of G-CSF
    name
    Pegfilgrastim
    other Names
    1. Neulasta
    type
    DRUG
  6. arm Group Labels
    1. Treatment Plan
    description
    Cancer medication that interferes with the growth and spread of cancer cells in the body
    name
    Cyclophosphamide
    other Names
    1. Cyclophosphamide 2000 MG
    2. Cytoxan
    type
    DRUG
  7. arm Group Labels
    1. Treatment Plan
    description
    Vincristine is a chemotherapy medication used to treat cancer. Vincristine works by stopping the cancer cells from separating into 2 new cells to stops the growth of the cancer
    name
    Vincristine
    other Names
    1. Vincrex
    2. Vincasar PFS
    3. Oncovin
    type
    DRUG
  8. arm Group Labels
    1. Treatment Plan
    description
    Leucovorin is used to prevent harmful effects of methotrexate when methotrexate is used to treat certain types of cancer.
    name
    Leucovorin
    other Names
    1. Wellcovorin
    type
    DRUG
  9. arm Group Labels
    1. Treatment Plan
    description
    Methotrexate is a chemotherapy medication used to treat cancer
    name
    Methotrexate
    other Names
    1. Rheumatrex
    2. Trexall
    type
    DRUG
  10. arm Group Labels
    1. Treatment Plan
    description
    Doxorubicin Hydrochloride is a chemotherapy medication used to treat cancer
    name
    Doxorubicin Hydrochloride
    other Names
    1. Adriamycin
    type
    DRUG
  11. arm Group Labels
    1. Treatment Plan
    description
    Medication used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma
    name
    Cytarabine
    other Names
    1. Ara-C
    2. HiDAC
    type
    DRUG
  12. arm Group Labels
    1. Treatment Plan
    description
    Etoposide is a is a chemotherapy medication used to treat cancer
    name
    Etoposide
    other Names
    1. Etopophos
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
21
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Progression-Free Survival will be defined the percentage of participants alive and progression-free at median follow up of 25 months. Patients will be routinely followed for disease progression and those who die without a reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress or die will be censored at the day of their last treatment assessment. Patients who have not received study regimen or did not have on-study treatment assessments will be censored on the day they entered the trial. Patients who receive chemotherapy for reasons other than documented progression of disease or clinical progression without documented progression will be censored on the earliest date of subsequent therapy
    measure
    Progression Free Survival
    time Frame
    Up to 3 years
secondary Outcomes
  1. description
    Overall Survival will be defined the percentage of participants alive at median follow up of 25 months. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. The analysis is expected to occur up to 60 months after the first patient is entered the trial.
    measure
    Overall Survival Rate
    time Frame
    Up to 5 years
  2. description
    The complete response rate will be defined as the total number of patients who have defined complete response using study regimen (intensive induction therapy/progressive chemotherapy/stem cell rescue), divided by the number of patients entered in the trial using response-evaluable patients.
    measure
    Complete Response Rate
    time Frame
    Up to 3 years
  3. description
    The time to response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) in months.
    measure
    Median Time to Response
    time Frame
    Up to 2 years
Full study description
brief Summary
This study examines the use of denileukin diftitox (Ontak) for patients with peripheral T-cell lymphoma who are candidates for autologous stem cell transplants.
detailed 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 gemcitabine, vinorelbine, Doxil (GND) will be used followed by two cycles of augmented dose Cyclophosphamide (CHOP) plus high-dose methotrexate (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 HiDAC/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.
Source references
Source notices and limitations
    Discovery and provenance
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      edge id
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      primary nct id
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      payload
      clinical indication matching status
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      true
      id
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      link basis
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      nct id
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      occurrences
      1. context exact
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        11
        exact text
        NCT00632827
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/3/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      772fddf851a1c0294295fec510cdbe4e35f84af78ab14f29131ef09ecb0f7360

    Preserved source evidence · Not medical advice