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Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil


Phase 1/Phase 2
N/A
74 Years
Not Enrolling
Both
Cancer

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Trial Information

Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil


OBJECTIVES: I. Determine the risk of graft rejection associated with the addition of
fludarabine to a nonmyeloablative conditioning regimen in patients with malignancies
treatable by allogeneic bone marrow (stem cell) transplantation. II. Compare the rate of
graft rejection in patients treated with this regimen vs patients previously untreated with
fludarabine. III. Determine the rate of acute grade II/IV graft versus host disease (GVHD)
and chronic GVHD in these patients treated with fludarabine, low dose total body
irradiation, and allogeneic peripheral blood stem cell transplantation followed by
immunosuppression with cyclosporine and mycophenolate mofetil.

OUTLINE: This is a multicenter study. Patients receive fludarabine IV on days -4 to -2, and
total body irradiation followed by filgrastim (G-CSF) mobilized allogeneic peripheral blood
stem cell transplantation on day 0. Patients also receive oral cyclosporine twice daily on
days -3 to 56 and oral mycophenolate mofetil twice daily on days 0 to 27. Following
completion of immunosuppression therapy patients with stable mixed chimerism and no evidence
of graft versus host disease (GVHD) receive donor lymphocytes IV over 30 minutes on or after
day 65. Treatment repeats every 65 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Patients are followed weekly until day 90 after last
lymphocyte infusion, at 4, 6, 12, 18, and 24 months, and then annually thereafter.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: 50 to 74 years old and diagnosed with non-Hodgkin's lymphoma
(NHL), chronic lymphocytic leukemia (CLL), or multiple myeloma Not eligible for curative
autologous transplantation or failed prior autologous transplantation NHL and CLL patients
must have failed prior therapy with an alkylating agent and/or fludarabine or be at high
risk for relapse Multiple myeloma patients must have stage II or III disease and received
prior chemotherapy OR Under 50 years old and diagnosed with NHL, CLL, or multiple myeloma
Not eligible for curative autologous transplantation At high risk for regimen related
toxicity due to prior autologous transplantation or preexisting medical condition OR Under
75 years old and diagnosed with other malignant disease treatable by allogeneic bone
marrow transplantation Not eligible for curative autologous transplantation At high risk
for toxicity related to standard high dose regimens due to a preexisting chronic disease
affecting kidneys, liver, lungs, and heart Includes the following likely diseases:
Myelodysplastic syndrome Myeloproliferative syndromes Acute leukemia with less than 10%
blasts Amyloidosis Hodgkin's disease Renal cell carcinoma OR Other malignancies for which
patient has declined standard allografts No rapidly progressive aggressive NHL unless in
minimal disease state No active CNS involvement Must have HLA genotypically or
phenotypically identical related donor meeting these criteria: 12 to 74 years old
(pediatric donors will provide bone marrow) No identical twin Not pregnant HIV negative No
known allergy to filgrastim (G-CSF) No concurrent serious systemic illness Hormone
receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Under 75 Menopausal status: Not specified Performance
status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Not specified
Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGPT and SGOT under
4 times ULN Renal: Renal failure allowed Cardiovascular: Cardiac ejection fraction at
least 40% No poorly controlled hypertension Pulmonary: No severe defects in pulmonary
function No supplementary continuous oxygen Other: Not pregnant or nursing Fertile
patients must use effective contraception during and for 1 year following study HIV
negative

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent
posttransplantation colony stimulating factors during mycophenolate mofetil Chemotherapy:
See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified
Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David G. Maloney, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1533.00

NCT ID:

NCT00006251

Start Date:

May 2000

Completion Date:

September 2005

Related Keywords:

  • Cancer
  • stage III breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • refractory multiple myeloma
  • recurrent childhood rhabdomyosarcoma
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • disseminated neuroblastoma
  • recurrent neuroblastoma
  • recurrent Wilms tumor and other childhood kidney tumors
  • stage II multiple myeloma
  • stage III multiple myeloma
  • recurrent childhood lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • stage III malignant testicular germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • untreated childhood acute lymphoblastic leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • chronic idiopathic myelofibrosis
  • childhood acute promyelocytic leukemia (M3)
  • testicular embryonal carcinoma
  • testicular choriocarcinoma
  • testicular teratoma
  • testicular yolk sac tumor
  • testicular embryonal carcinoma and teratoma
  • testicular embryonal carcinoma and teratoma with seminoma
  • testicular embryonal carcinoma and yolk sac tumor
  • testicular embryonal carcinoma and yolk sac tumor with seminoma
  • testicular embryonal carcinoma and seminoma
  • testicular yolk sac tumor and teratoma
  • testicular yolk sac tumor and teratoma with seminoma
  • testicular choriocarcinoma and yolk sac tumor
  • testicular choriocarcinoma and embryonal carcinoma
  • testicular choriocarcinoma and teratoma
  • testicular choriocarcinoma and seminoma
  • refractory hairy cell leukemia
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent ovarian germ cell tumor
  • ovarian yolk sac tumor
  • ovarian embryonal carcinoma
  • ovarian polyembryoma
  • ovarian choriocarcinoma
  • ovarian teratoma
  • ovarian immature teratoma
  • ovarian mature teratoma
  • ovarian monodermal and highly specialized teratoma
  • ovarian mixed germ cell tumor
  • acute undifferentiated leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • poor prognosis metastatic gestational trophoblastic tumor
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • graft versus host disease
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • previously treated childhood rhabdomyosarcoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • childhood myelodysplastic syndromes
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Colorado Cancer CenterDenver, Colorado  80262
Beckman Research Institute, City of HopeLos Angeles, California  91010
Stanford UniversityStanford, California  94305