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Chronic Lymphocytic LeukemiaPhase 1NCT00442130

Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination

A Phase 1 study testing GM-K562 vaccine and stem cell transplantation in people with Chronic Lymphocytic Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to assess the safety and immune activity of a vaccine made from the participant's own cancer cells, when administered after a reduced intensity transplant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
GM-K562 vaccine and stem cell transplantation
Type of treatment
Vaccines, Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
Feb 2007to Apr 2020
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

  • Advanced CLL, defined as no response or progressive disease during standard nucleoside analogue based regimen; or, evidence of progressive disease within 24 months of completion of nucleoside analogue regimen; or, intolerance to fludarabine; or, failure to achieve complete remission following salvage regimen.
  • no sites of adenopathy > 5cm
  • (8/8) HLA matched related or unrelated donor available.
  • Must have prior banked tumor, collected by peripheral blood draw, leukapheresis, bone marrow biopsy or by lymph node dissection, per DF/HCC protocol 06-200
  • ECOG performance status 0-2

Who cannot join

  • Serum creatinine greater than or equal to 2.0mg/dl
  • ALT or AST greater than or equal to 3x ULN
  • Total bilirubin greater than or equal to 2.0mg/dl (except for patients with Gilbert's syndrome)
  • Cardiac ejection fraction greater than or equal to 30%
  • HIV infection
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Reduced Intensity Stem Cell Transplantation for Advanced Chronic Lymphocytic Leukemia Followed by Vaccination With Lethally Irradiated Autologous Tumor Cells Admixed With Granulocyte Macrophage-colony Stimulating Factor Secreting K562 Cells

The purpose of this research study is to assess the safety and immune activity of a vaccine made from the participant's own cancer cells, when administered after a reduced intensity transplant. In recent years, researchers at Dana-Farber Cancer Institute have discovered that vaccines made from a patients's own cancer cells, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.

Read the detailed description
  • This study can be divided into four phases: 1) Screening; 2) Reduced intensity transplant phase; 3) Vaccinations (cycle 1 and cycle 2:each cycle lasts 7 weeks) and 4) Vaccine completion.
  • Screening Phase: After signing the consent form, participants will be asked to undergo some screening tests and procedures to find out if they are eligible to participate in the study. These tests and procedures are likely to be part of regular cancer care and may be done even if the patient does not take part in the research study. It is important to note that if insufficient numbers of the participant's leukemia cells to generate vaccine were collected on the CLL collection and banking study (DF/HCC study 06-200), then they will not be eligible to participate in this study.
  • Allogeneic reduced intensity stem cell transplant phase: The transplant phase of the study will begin when the participant is admitted to the hospital to receive chemotherapy and stem cell transplant. The minimum duration of hospitalization for the procedure is approximately 8 days. Undergoing transplant involves the following procedures and treatments: Central intravenous catheter; chemotherapy; medications to prevent graft versus host disease (GVHD); medication to prevent infections; physical exams; blood tests and bone marrow biopsy and aspirate.
  • Vaccination Phase: Vaccinations will be given in two cycles, of seven weeks each, that are identical with the exception of when they are administered. Cycle 1 vaccination will begin approximately one month after the stem cells have been infused, provided there is no significant evidence of GVHD. Cycle 2 vaccination will be being approximately one month after discontinuing tacrolimus, provided there is no evidence of severe acute or chronic GVHD. The vaccine will be given 6 times over a period of two months. The participant will receive vaccination shots once weekly for 3 vaccines and then every other week for 3 vaccines.
  • Skin biopsies will be done after the first and after the fifth vaccinations. Current status of the participants CLL will be assessed to determine how the disease has responded to transplant and vaccination. These tests include analysis of bone marrow and blood tests.
  • Vaccine completion phase: After one cycle of vaccination is completed, the participant will return to the outpatient clinic monthly for check-ups for 6 visits, to monitor the effects of the vaccine.
  • Since this trial involves the use of genetically modified cells, it is recommended that participants on this trial undergo annual checkups for at least 20 years, in order to monitor for long term effects of the vaccination treatment.
Being tested
GM-K562 vaccine, stem cell transplantation
Keywords
GM-CSF, GM-K562, vaccine
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.

  • GM-K562 vaccineBiological

    The vaccine will be administered over 1 cycle of 7 weeks, that begins 1 month after stem cell transplant. The vaccine will be given 6 times over 2 months -- once a week for three weeks then every other week for 3 vaccines.

  • stem cell transplantationProcedure or surgery

    Participants will be admitted to the hospital for approximately 8 days to receive chemotherapy and stem cell transplantation

Study groups in NCT00442130
Study groupRoleWhat they receive
GM-K562 VaccineExperimentalBiological/Vaccine: GM-K562 vaccine The vaccine will be administered over 1 cycle of 7 weeks, that begins 1 month after stem cell transplant. The vaccine will be given 6 times over 2 months -- once a week for three weeks then every other week for 3 vaccines. Procedure/Surgery: stem cell transplantation Participants will be admitted to the hospital for approximately 8 days to receive chemotherapy and stem cell transplantation
Receives: Biological: GM-K562 vaccine; Procedure: stem cell transplantation

What is being measured

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

  1. To assess the safety and toxicity of vaccination with lethally irradiated autologous CLL cells admixed with GM-562 cells following reduced intensity allogeneic stem cell transplant for CLL patients with advanced disease.

    Measured: 2 years

Secondary outcomes (2)

  1. To characterize the biologic activity in response to vaccination with lethally irradiated autologous CLL cells admixed with GM-562 cells, following reduced intensity allogeneic stem cell transplant

    Measured: 2 years

  2. to estimate duration of disease response, disease free and overall survival.

    Measured: 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 posted1 Mar 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionFeb 2014
  4. Study completionApr 2020

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00442130
Sponsor's protocol ID
06-196
Status last verified
Sep 2020
First submitted
27 Feb 2007
Last updated
17 Sep 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Burkhardt UE, Hainz U, Stevenson K, Goldstein NR, Pasek M, Naito M, Wu D, Ho VT, Alonso A, Hammond NN, Wong J, Sievers QL, Brusic A, McDonough SM, Zeng W, Perrin A, Brown JR, Canning CM, Koreth J, Cutler C, Armand P, Neuberg D, Lee JS, Antin JH, Mulligan RC, Sasada T, Ritz J, Soiffer RJ, Dranoff G, Alyea EP, Wu CJ. Autologous CLL cell vaccination early after transplant induces leukemia-specific T cells. J Clin Invest. 2013 Sep;123(9):3756-65. doi: 10.1172/JCI69098. Epub 2013 Aug 5.

    PubMed 23912587

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GM-K562 vaccine and stem cell transplantation in people with Chronic Lymphocytic Leukemia, run by Dana-Farber Cancer Institute 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 17 Sep 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To assess the safety and toxicity of vaccination with lethally irradiated autologous CLL cells admixed with GM-562 cells following reduced intensity allogeneic stem cell transplant for CLL patients with advanced disease. (time frame: 2 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 NCT00442130, which also lists 1 linked publication.

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 17 Sep 2020.

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