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Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic Stem Cell Transplantation

Primary Purpose

Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome-Refractory Anemia With Excess Blasts

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GM-K562/leukemia cell vaccine

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring vaccination, AML, CMML, MDS-RAEB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who have received an allogeneic bone marrow or peripheral blood stem cell transplant for AML, meeting one of the following: 1) AML arising from MDS or MDP 2)AML CR1 associated with high risk cytogenetics 3) AML transplanted in induction failure or relapse 4) AML transplanted in second remission or beyond 5) AML in patient 60 years or older
Patients who have received an allogeneic bone marrow or peripheral blood stem cell transplant for MDS-RAEB or CMML
18 years of age or older
Donor is a related or unrelated donor who is at least 9/10 matched at HLA-A, B, C, DRB1, and DQB1 by antigen level typing at class 1 and allele level typing at class II
Recipients of myeloablative or reduced intensity conditioning transplants are eligible
Patient must have sufficient autologous tumor cells banked at DFCI (on companion tissue banking protocol) for vaccine generation prior to transplantation
No active GVHD requiring systemic corticosteroid therapy
No conditions requiring systemic corticosteroid therapy greater than or equal to 20mg methylprednisolone or equivalent
No uncontrolled infection
Adequate hematopoietic engraftment with ANC >500 off growth factor support, and platelet >10k without transfusion
No non-hematologic toxicity of CTC Grade 3 or greater
ECOG Performance Status 0-2

Exclusion Criteria:

Recipients of cord blood transplant
Patients with uncontrolled CNS disease
Patients with relapsed/persistent disease after transplant who are expected to require rapid withdrawal of immune suppression, cytoreductive therapy, or have a life expectancy of < 3 months
Concurrent participation in other transplant clinical trials where GVHD and/or disease relapse are primary endpoints
Patients deemed medically or psychologically unfit by treating physician or study investigator

Sites / Locations

Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GM-K562/leukemia cell vaccine

Arm Description

Biological/Vaccine: GM-K562/leukemia cell vaccine Cultured cell line genetically changed to secrete GM-CSF mixed with irradiated leukemia cells obtained from the participant. A total of 6 vaccine will be given. Vaccines 1-3 will be given once a week. Vaccines 4-6 will be given every other week.

Outcomes

Primary Outcome Measures

To assess the safety of vaccination, as measured by vaccine related reactions and incidence of grade III-IV acute GVHD.

Secondary Outcome Measures

To assess the efficacy of vaccination with GM-K562/leukemia cell vaccine following allogeneic stem cell transplantation in this patient population.

To characterize the biologic responses and leukemia specific immune responses after vaccination with GM-K562/leukemia cell vaccine following allogeneic stem cell transplant.

To determine duration of disease response, disease free and overall survival

Full Information

NCT ID

NCT00809250

First Posted

December 15, 2008

Last Updated

September 15, 2020

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT00809250

Brief Title

Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic Stem Cell Transplantation

Official Title

Vaccination With Lethally Irradiated Autologous Myeloblasts With Granulocyte Macrophage-colony Stimulating Factor Secreting K562 Cells (GM-K562) in Patients With Advanced MDS or AML After Allogeneic Hematopoietic Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

November 2008 (Actual)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to determine if the GM-K562/leukemia cell vaccine can be safely given soon after allogeneic marrow or blood stem cell transplant. The GM-K562/leukemia cell vaccine is composed of a cultured cell line that has been genetically modified to secrete GM-CSF, a naturally occuring substance in the body that stimulates the immune system. The vaccine is a mixture of the GM-K562 cells (radiated to prevent them from growing in the participants body) with the participant's previously frozen and killed leukemia cells. By mixing the GM-K562 with the leukemia cells, we would like to study whether this vaccine combination will stimulate the participant's new immune system to recognize and fight against their MDS/AML cancer cells.

Detailed Description

Participants will be given the GM-K562/Leukemia call vaccine as in injection under the skin a total of six times. The first 3 vaccines will be given weekly and vaccines 4 through 6 will be given every other week. Therefore, it is expected that the vaccines will be completed over a period of 9 weeks. During the 9 week vaccination period, participants will have physical exams to monitor for any side effects or graft-versus-host disease (GVHD). Bone marrow biopsies will be performed a the time of enrollment for this study, 4 weeks after completion of 6 GM-K562/Leukemia cell vaccines, and 1 year after the participants transplant. As a way of testing whether the GM-K562/Leukemia cell vaccine is triggering any immune response to the participants leukemia, we will be injecting a small amount of leukemia cells (after they are killed with radiation) under the participants skin to see if the body will generate a reaction to the leukemia cells. This test is called a leukemia cell delayed hypersensitivity test (DTH). This test will be performed three times during the study, on the weeks of the 1st vaccine, 5th vaccine and 4 weeks after the 6th vaccine. There are a total of 5 skin biopsies required as part of this study. Biopsies will be taken from the vaccination sites 2-3 days after the first and fifth vaccine. Similar biopsies will be taken from the DTH sites after the 1st vaccination, 5th vaccination and 4-6 weeks after the 6th vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome-Refractory Anemia With Excess Blasts

Keywords

vaccination, AML, CMML, MDS-RAEB

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GM-K562/leukemia cell vaccine

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

GM-K562/leukemia cell vaccine

Intervention Description

Cultured cell line genetically changed to secrete GM-CSF mixed with irradiated leukemia cells obtained from the participant. A total of 6 vaccine will be given. Vaccines 1-3 will be given once a week. Vaccines 4-6 will be given every other week.

Primary Outcome Measure Information:

Title

To assess the safety of vaccination, as measured by vaccine related reactions and incidence of grade III-IV acute GVHD.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

To assess the efficacy of vaccination with GM-K562/leukemia cell vaccine following allogeneic stem cell transplantation in this patient population.

Time Frame

2 years

Title

To characterize the biologic responses and leukemia specific immune responses after vaccination with GM-K562/leukemia cell vaccine following allogeneic stem cell transplant.

Time Frame

2 years

Title

To determine duration of disease response, disease free and overall survival

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who have received an allogeneic bone marrow or peripheral blood stem cell transplant for AML, meeting one of the following: 1) AML arising from MDS or MDP 2)AML CR1 associated with high risk cytogenetics 3) AML transplanted in induction failure or relapse 4) AML transplanted in second remission or beyond 5) AML in patient 60 years or older Patients who have received an allogeneic bone marrow or peripheral blood stem cell transplant for MDS-RAEB or CMML 18 years of age or older Donor is a related or unrelated donor who is at least 9/10 matched at HLA-A, B, C, DRB1, and DQB1 by antigen level typing at class 1 and allele level typing at class II Recipients of myeloablative or reduced intensity conditioning transplants are eligible Patient must have sufficient autologous tumor cells banked at DFCI (on companion tissue banking protocol) for vaccine generation prior to transplantation No active GVHD requiring systemic corticosteroid therapy No conditions requiring systemic corticosteroid therapy greater than or equal to 20mg methylprednisolone or equivalent No uncontrolled infection Adequate hematopoietic engraftment with ANC >500 off growth factor support, and platelet >10k without transfusion No non-hematologic toxicity of CTC Grade 3 or greater ECOG Performance Status 0-2 Exclusion Criteria: Recipients of cord blood transplant Patients with uncontrolled CNS disease Patients with relapsed/persistent disease after transplant who are expected to require rapid withdrawal of immune suppression, cytoreductive therapy, or have a life expectancy of < 3 months Concurrent participation in other transplant clinical trials where GVHD and/or disease relapse are primary endpoints Patients deemed medically or psychologically unfit by treating physician or study investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincent Ho, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic Stem Cell Transplantation

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