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A Phase I-II Trial of Adoptive Immunotherapy Using Haploidentical, Related Donor-Lymphocyte Infusions and IL-2 After Autologous Stem Cell Transplantation for Advanced Lymphoid Malignancies


Phase 1/Phase 2
18 Years
69 Years
Not Enrolling
Both
Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase I-II Trial of Adoptive Immunotherapy Using Haploidentical, Related Donor-Lymphocyte Infusions and IL-2 After Autologous Stem Cell Transplantation for Advanced Lymphoid Malignancies


OBJECTIVES:

Primary

- Determine the feasibility and toxicity of haploidentical related donor lymphocyte
infusions (DLI) and interleukin-2, in terms of acute graft-versus-host-disease, graft
failure, and transplant-related mortality, in patients with relapsed advanced lymphoid
malignancies undergoing autologous stem cell transplantation.

Secondary

- Determine the extent, degree, and duration of donor chimerism in patients treated with
this regimen.

- Determine, preliminarily, activity of haploidentical DLI, as measured by complete
response rate, in these patients.

OUTLINE: This is a pilot study.

Patients receive high-dose melphalan IV over 15-60 minutes on day -2 and undergo autologous
stem cell transplantation on day 0. Patients receive haploidentical related donor lymphocyte
infusions (DLI) IV on days 1, 5*, and 10* and interleukin-2 (IL-2) IV continuously on days
1-12.

NOTE: *DLI are not administered on days 5 or 10 if grade 3 or 4 graft-versus-host disease is
present

After completion of study treatment, patients are followed monthly for 3 months and then
every 3-12 months thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following advanced lymphoid malignancies:

- Multiple myeloma, meeting both of the following criteria:

- Deletion of chromosome 13

- Elevated pre-transplant lactic dehydrogenase

- Chronic lymphocytic leukemia (CLL)

- Failed ≥ 2 prior conventional chemotherapy regimens, including fludarabine

- Small lymphocytic lymphoma

- Follicular non-Hodgkin's lymphoma

- Received ≥ 3 prior conventional chemotherapy regimens

- Mantle cell lymphoma

- Received ≥ 3 prior conventional chemotherapy regimens

- Predicted poor outcome and relapsed disease after undergoing autologous stem cell
transplantation ≥ 6 months ago

- Measurable disease, defined as any evidence of disease by scans or blood or urine
analysis

- At least 8 x 10^6 autologous CD34-positive cells/kg available for transplantation

- Stem cell mobilization allowed

- Haploidentical related donor available

- Sex-mismatched

- Identical for 1 HLA haplotype AND mismatched for ≥ 1 HLA-A, -B, -C, or DRB1
locus of the unshared haplotype

- No HLA-identical related or unrelated donor available

- Not eligible for first-line autologous stem cell transplantation on protocol
FHCRC-1368.00, FHCRC-1366.00, FHCRC-1461.00, or FHCRC-1595.00

- No bulky disease, defined as total volume of all measurable tumor > 500 cc

- No CNS disease resistant to therapy

PATIENT CHARACTERISTICS:

Age

- 18 to 69

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Liver function tests or liver enzymes ≤ 2 times upper limit of normal

Renal

- Not specified

Cardiovascular

- Ejection fraction ≥ 45%

- No symptomatic cardiac disease

Pulmonary

- DLCO ≥ 50%

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV Negative

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- No prior allogeneic stem cell transplantation

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No concurrent contrast dye during and for 3 weeks after completion of interleukin-2
administration

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Feasibility

Safety Issue:

No

Principal Investigator

William I. Bensinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1838.00

NCT ID:

NCT00248430

Start Date:

August 2003

Completion Date:

July 2007

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • graft versus host disease
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • refractory chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • recurrent mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • Neoplasms
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Seattle Cancer Care AllianceSeattle, Washington  98109