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Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020670
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Last Update Posted : June 20, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nicholas Haining, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 11, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date June 20, 2017
Actual Study Start Date  ICMJE February 20, 2001
Actual Primary Completion Date April 1, 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
Rate Of Successful Vaccine Preparation [ Time Frame: 6 weeks ]
Vaccine preparation is a success if an adequate number of CD40 activated cells (at least 1 x 10^8 cells) can be generated.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Official Title  ICMJE A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells
Brief Summary The prognosis for children and adults with acute lymphoblastic leukemia (ALL) has improved significantly over the years. Nevertheless, patients who experience disease relapse or induction failure along with patients having unfavorable genetics [t(4;11) or t(9;22)] have dismal prognosis. For these patients, novel therapeutic approaches such as immunotherapy are needed. In this clinical trial, investigators evaluate whether it is feasible to make a vaccine from leukemia cells and whether this vaccine enables direct immunity against cancer cells in patients.
Detailed Description


  • To determine feasibility of generating a cellular vaccine composed of CD40-activated autologous ALL cells
  • To determine feasibility of vaccine administration according to the proposed schedule
  • To determine toxicity of vaccination with CD40-activated autologous ALL cells


  • To assess ALL-specific immunity following vaccination
  • To assess the generation of immunity to control antigens
  • To develop preliminary information on effect vaccination on tumor response
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia
Intervention  ICMJE Biological: CD 40
Other Name: Autologous tumor cell vaccine
Study Arms  ICMJE Experimental: CD40 Cell Vaccination
Patients will undergo tumor cell collection followed by vaccine preparation and then vaccination. Autologous acute lymphoblastic leukemia (ALL) cells are harvested, cultured with CD40 ligand, pulsed with keyhole limpet hemocyanin (KLH), and then irradiated to produce the vaccine. Patients receive either 1 x 10^7 or 1 x 10^8 CD40 cells/vaccination depending on the number of tumor cells obtained. Vaccinations are administered every two weeks as outpatient therapy. Evaluable patients receive the course of at least 4 vaccinations at weeks 0, 2, 4, 6. Patients may continue receiving vaccinations every 2 weeks if chemotherapy is not required for symptomatic disease.
Intervention: Biological: CD 40
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 1, 2003
Actual Primary Completion Date April 1, 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • B-cell acute lymphoblastic leukemia
  • Disease involving at least 30% of bone marrow or circulating blasts
  • In first relapse with at least 1 of the following high-risk features:

    • Age under 1 year at diagnosis
    • Age over 18 years at diagnosis
    • t(9;22)
    • Occurrence of first relapse less than 18 months after diagnosis
    • In second relapse or beyond
    • Refractory disease
  • Successful generation of adequate CD40 ligand-activated autologous tumor cell vaccine
  • Less than 1 year since tumor cell collection
  • Patients in first relapse or beyond must be ineligible for or have declined allogeneic bone marrow transplantation in order to receive study vaccine
  • Patients need not be in complete remission to receive study vaccine
  • Patients may have received an allogeneic hematopoetic stem cell transplant in the past
  • No chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment or within 3 weeks of vaccination
  • Adequate hepatic function as defined by: Bilirubin < 2x normal; AST < 3x normal; ALT < 6x normal
  • Adequate renal function defined by: Creatinine < 2x normal
  • <1 year since tumor cell collection

Exclusion Criteria

  • Concurrent treatment as part of another therapeutic research protocol
  • Pregnancy or nursing mothers
  • Clinically significant pulmonary or cardiac disease
  • Clinically significant autoimmune disease
  • Documented infection that is active and/or not responding to therapy
  • Evidence of HIV infection or known positive HIV serology
  • Lansky performance scale (if <18yo) <60%, Karnofsky performance scale (if >18yo) >60%
  • Once vaccination course has started: patients may not receive chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment, hematopoetic growth factors. However between tumor cell collection and vaccine administration, patients may receive non-protocol chemotherapy.


It is anticipated that there will be a number of patients at first relapse who are eligible for tumor cell collection and vaccine preparation but who are not eligible to receive the vaccination course. These patients will be evaluable for Objective 3.1.1 (feasibility of vaccine preparation). Patients at first relapse who are eligible for vaccine preparation but not administration should instead be treated with standard salvage regimens which may include allogeneic bone marrow transplantation according to the judgement of their primary oncologist. However, these patients represent a population at extremely high risk for progression of their disease following salvage therapy. Many of these patients will therefore be likely to fulfill eligibility criteria for vaccination in the future (i.e.

should they relapse again, or fail to enter 2nd complete remission). The majority of those patients who relapse for a second time will do so within 1 year. Those patients who become eligible for vaccination because of 2nd relapse within 1 year of tumor cell collection will receive the original vaccine and will not have further vaccine made from tumor cells collected at the time of 2nd relapse. Given the proliferative thrust of the disease in many patients, it will be advantageous to have vaccines already prepared for these patients to reduce the amount of time from 2nd relapse to vaccination.***

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00020670
Other Study ID Numbers  ICMJE 00-053
P01CA068484 ( U.S. NIH Grant/Contract )
P30CA006516 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicholas Haining, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: W. Nicholas Haining, BM, BCh Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP