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Posttransplant Immunotherapy With Donor Lymphocyte Infusions and Autologous Tumor Vaccines After HLA-Matched Transplant


N/A
18 Years
70 Years
Not Enrolling
Both
Leukemia, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Posttransplant Immunotherapy With Donor Lymphocyte Infusions and Autologous Tumor Vaccines After HLA-Matched Transplant


OBJECTIVES:

- Determine time to relapse and overall survival of patients with high-risk acute myeloid
leukemia, acute lymphoblastic leukemia, or multiple myeloma treated with autologous
tumor cell vaccine with or without donor lymphocyte infusion after HLA-matched related
sibling nonmyeloablative hematopoietic stem cell transplantation.

- Evaluate the safety and tolerability of this regimen in these patients.

- Determine the maximum tolerated dose of donor lymphocyte infusions in these patients.

OUTLINE: Patients undergo collection of tumor cells for production of the cancer cell
vaccine and then undergo HLA-matched related sibling nonmyeloablative hematopoietic stem
cell transplantation (HSCT). Patients then receive cancer cell vaccine with or without donor
lymphocyte infusion. The donor lymphocytes are obtained from the same relative who donated
stem cells for the HSCT.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Confirmed diagnosis of 1 of the following:

- Acute myeloid leukemia (AML), meeting any of the following criteria:

- Relapsed disease

- AML arising from myelodysplastic syndromes

- Primary refractory disease

- De novo AML with high-risk features

- Acute lymphoblastic leukemia (ALL), meeting any of the following criteria:

- De novo ALL that is Philadelphia chromosome positive or with t(4,11)
cytogenetic features

- Relapsed disease

- Multiple myeloma (in need of treatment)

- Planning to undergo HLA-matched related sibling nonmyeloablative hematopoietic stem
cell transplantation

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to relapse

Safety Issue:

No

Principal Investigator

Carol A. Huff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000543531

NCT ID:

NCT00469820

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Leukemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • secondary acute myeloid leukemia
  • stage III multiple myeloma
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • refractory multiple myeloma
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410