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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

Phase 1
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia

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Trial Information

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

- 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 participants leukemia cells to
generate vaccine were collected on the CLL collection and banking study (DFHCC 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Cardiac ejection fraction <30%

- HIV infection

- Pregnancy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Catherine J. Wu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

July 2021

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • GM-CSF
  • GM-K562
  • vaccine
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Dana-Farber Cancer Institute Boston, Massachusetts  02115