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

September 15, 2020 updated by: Catherine Wu, MD, Dana-Farber Cancer Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 syndrome)
  • Cardiac ejection fraction greater than or equal to 30%
  • HIV infection
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GM-K562 Vaccine

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2 years
2 years
to estimate duration of disease response, disease free and overall survival.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Catherine J. Wu, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

February 27, 2007

First Submitted That Met QC Criteria

February 27, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphocytic Leukemia

Clinical Trials on GM-K562 vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe