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Peripheral T-Cell LymphomaPhase 2NCT00632827

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

A Phase 2 study testing Gemcitabine, Navelbine and Doxorubicin Hydrochloride Liposome Injection in people with Peripheral T-Cell Lymphoma, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Peripheral T-Cell Lymphoma
What is being tested?
Gemcitabine, Navelbine and Doxorubicin Hydrochloride Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
1 Jul 2008to 23 Jun 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 25Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

Read the 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.

Being tested
Gemcitabine, Navelbine, Doxorubicin Hydrochloride Liposome Injection, Granulocyte-colony stimulating factor (G-CSF), Pegfilgrastim
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called Gemzar

    Chemotherapy medication used to treat a number of types of cancer

  • NavelbineDrug

    Also called Vinorelbine

    Navelbine is an chemotherapy medication used to treat a number of types of cancer

  • Doxorubicin Hydrochloride Liposome InjectionDrug

    Also called Doxil

    Doxorubicin Hydrochloride Liposome Injection is an anti-cancer chemotherapy drug

  • Granulocyte-colony stimulating factor (G-CSF)Drug

    Also called G-CSF

    G-CSF is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.

  • PegfilgrastimDrug

    Also called Neulasta

    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

  • CyclophosphamideDrug

    Also called Cyclophosphamide 2000 MG, Cytoxan

    Cancer medication that interferes with the growth and spread of cancer cells in the body

  • VincristineDrug

    Also called Vincrex, Vincasar PFS, Oncovin

    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

  • LeucovorinDrug

    Also called Wellcovorin

    Leucovorin is used to prevent harmful effects of methotrexate when methotrexate is used to treat certain types of cancer.

  • MethotrexateDrug

    Also called Rheumatrex, Trexall

    Methotrexate is a chemotherapy medication used to treat cancer

  • Doxorubicin HydrochlorideDrug

    Also called Adriamycin

    Doxorubicin Hydrochloride is a chemotherapy medication used to treat cancer

  • CytarabineDrug

    Also called Ara-C, HiDAC

    Medication used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma

  • EtoposideDrug

    Also called Etopophos

    Etoposide is a is a chemotherapy medication used to treat cancer

  • CarmustineDrug

    Also called BCNU

    Carmustine is a chemotherapy medication used to treat cancer

  • Denileukin diftitoxDrug

    Also called Ontak

    Denileukin diftitox is an antineoplastic agent, an engineered protein combining Interleukin-2 and Diphtheria toxin. Denileukin diftitox could bind to Interleukin-2 receptors and introduce the diphtheria toxin into cells that express those receptors, killing the cells

Study groups in NCT00632827
Study groupRoleWhat they receive
Treatment PlanExperimental(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
Receives: Drug: Gemcitabine; Drug: Navelbine; Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: Granulocyte-colony stimulating factor (G-CSF); Drug: Pegfilgrastim; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Leucovorin; Drug: Methotrexate; Drug: Doxorubicin Hydrochloride; Drug: Cytarabine; Drug: Etoposide; Drug: Carmustine; Drug: Denileukin diftitox

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    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

    Measured: Up to 3 years

Secondary outcomes (3)

  1. Overall Survival Rate

    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.

    Measured: Up to 5 years

  2. Complete Response Rate

    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.

    Measured: Up to 3 years

  3. Median Time to Response

    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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2008 (estimated)
  2. Study start1 Jul 2008
  3. Primary completion23 Jun 2014
  4. Study completion23 Jun 2016

Why it stopped: Manufacturing shortage of both Diftitox and Doxil

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00632827
Sponsor's protocol ID
072518
Other IDs
NCI-2011-01285
Status last verified
Apr 2020
First submitted
28 Feb 2008
Last updated
27 Apr 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Navelbine and Doxorubicin Hydrochloride Liposome Injection in people with Peripheral T-Cell Lymphoma, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00632827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.

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