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CHRONIC LYMPHOCYTIC B-LEUKEMIAPhase 1CLONTAKNCT00224354

Lymphocytic B-Leukemia (B-CLL) w/Human IL-2 Gene Modified & Human CD40 Ligand-Expressing Autologous Tumor Cells

A Phase 1 study testing IL-2 secreting and hCL4OL-expressing autologous B-CLL cells, IL-2 and CD40L in people with CHRONIC LYMPHOCYTIC B-LEUKEMIA, run by Baylor College of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In the laboratory, we will put a special gene into cancer cells that have been taken from the subject. This gene will make the cells produce interleukin 2 (IL-2), which may help the patient's immune system kill cancer cells. Also, we will use CD40 ligand (CD40L) with the IL-2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CHRONIC LYMPHOCYTIC B-LEUKEMIA
What is being tested?
IL-2 secreting and hCL4OL-expressing autologous B-CLL cells, IL-2 and CD40L
Type of treatment
Injection or infusion
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2005to Dec 2009
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pre Inclusion Eligibility Criteria: Proof of B-CLL diagnosis not in Richter's transformation
  • Eligibility Criteria:
  • Manipulated B-CLL cells available (at least 6 injections)
  • B-CLL with measurable disease, not in Richter's transformation
  • Life expectancy greater than or equal to 10 weeks
  • ECOG 0-2 (see Section 4.3 of the full protocol for details)
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  • Recovered from the toxic effects of all prior chemotherapy
  • Absolute neutrophil count (ANC) greater than or equal to 500/mL
  • Absolute lymphocyte count (ALC) greater than or equal to 200/mL
  • Hemoglobin greater than or equal to 8 g/dL
  • Platelet count greater than or equal to 50,000/mL
  • Total bilirubin less than or equal to 1.5mg/dL -SGOT less than or equal to 2 x Normal
  • Normal PTT -Creatinine less than 3 x Normal (age-related) or Creatinine clearance > 80mg/min/1.73m2
  • Serum albumin level greater than or equal to 3 g/dl
  • Must not have received treatment with other investigational agents within the last 4 weeks
  • Practicing appropriate birth control during the study and for 3 months after the study is concluded.

Who cannot join

  • Congestive heart failure
  • Significant arrythmia or history of myocardial infarction
  • Active CNS disease or a history of seizure
  • Active infection / receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole
  • Seropositive for HIV
  • Pregnancy or lactation / will not use birth control methods
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  • Autoimmune disease (GvHD, immune thrombocytopenia-ITP or autoimmune hemolytic anemia-AIHA)
  • Receiving immunosuppressive drugs
  • Hypersensitivity to denileukin diftitox or any of its components: diphteria toxin, interleukin-2, or excipients

About this study

Official title: Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) With Human IL-2 Gene Modified and Human CD40 Ligand-Expressing Autologous Tumor Cells After Depletion of Regulatory T Cells

In the laboratory, we will put a special gene into cancer cells that have been taken from the subject. This gene will make the cells produce interleukin 2 (IL-2), which may help the patient's immune system kill cancer cells. Also, we will use CD40 ligand (CD40L) with the IL-2. Studies of cancers in animals and in cancer cells that are grown in laboratories have suggested adding the CD40L helps the IL-2 work better. Some of these new cells will then be given back to the subject as a vaccine shot.

We believe that a part of the subject's immune system (cells called T-reg cells) might try to kill off these special cells. If the T-reg cells do that, the vaccine would not work as well or last as long. To try to avoid this, before the special cells are put back into the subject's body, we will give them an intravenous (IV) dose of IL-2 immunotoxin (called denileuk diftitox or ONTAK). ONTAK should get rid of some of the T-reg cells in the subject's body which should help the special cells work better and longer.

The purpose of this study is to learn the safety and cancer-fighting effects of using IL-2 with the vaccine.

Read the detailed description

This is a phase I trial to assess the safety of depleting regulatory T (Treg) cells using 1-3 doses of an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox, ONTAK) in chronic lymphocytic leukemia (B-CLL) patients, followed by six subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L). Patients will receive a fixed dose (2 x 10e7) of IL-2 secreting B-cells together with 2 x 10e7 hCD40L expressing B-cells, representing a safe, well tolerated and immunogenic dose in our previous dose escalation study.

All eligible patients will be treated with six injections. Any patient whose disease regresses after the administration of 6 injections may be offered further injections of tumor vaccine if sufficient vaccine is available. There will be no use of placebo or control subjects.

Being tested
IL-2 secreting and hCL4OL-expressing autologous B-CLL cells, IL-2, CD40L, ONTAK, immunotoxin dose
Keywords
LYMPHOCYTIC, B-LEUKEMIA, B-CLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • IL-2 secreting and hCL4OL-expressing autologous B-CLL cellsBiological

    Patients will be treated with six subcutaneous injections of their IL-2-secreting and hCD40L-expressing autologous B-CLL cells, separated by one to two weeks in an immunological treatment window

  • IL-2Biological

    subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).

  • CD40LBiological

    subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).

  • ONTAKDrug

    an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox, ONTAK

  • immunotoxin doseBiological

    Also called ONTAK

    Days 0, 2, and 4 (18 ug/kg) i.v

What is being measured

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

  1. Safety of (Treg) cells using interleukin-2 immunotoxin directed to the CD25 antigen in(B-CLL) patients, then six (SC) injections of autologous leukemic cells modified to secrete (hIL-2) and to express (hCD40L).

    Measured: 15 years

  2. To obtain preliminary data on the anti-tumor effects of this treatment regimen.

    Measured: 15 years

Secondary outcomes (1)

  1. determine whether MHC-restricted or unrestricted anti-tumor immune responses are induced and sustained by the combination of Treg cell depletion and SC injections of B-CLL cells, which have been modified ex vivo to secrete hIL-2 and to express hCD40L

    Measured: 15 years

Timeline

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

  1. First posted23 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionDec 2009
  4. Study completionDec 2009

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00224354
Sponsor's protocol ID
17656
Other IDs
CLONTAK
Acronym
CLONTAK
Status last verified
May 2012
First submitted
21 Sep 2005
Last updated
21 May 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IL-2 secreting and hCL4OL-expressing autologous B-CLL cells, IL-2 and CD40L in people with CHRONIC LYMPHOCYTIC B-LEUKEMIA, run by Baylor College of Medicine.

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 16 inclusion and 9 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: withdrawn, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Safety of (Treg) cells using interleukin-2 immunotoxin directed to the CD25 antigen in(B-CLL) patients, then six (SC) injections of autologous leukemic cells modified to secrete (hIL-2) and to express (hCD40L). (time frame: 15 years). The study lists 2 primary outcomes in all. 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 NCT00224354.

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 21 May 2012.

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