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A Phase I/II Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Patients With Hematologic Malignancies Using Busulfan, Fludarabine and Total Body Irradiation


Phase 1/Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Precancerous Condition

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Trial Information

A Phase I/II Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Patients With Hematologic Malignancies Using Busulfan, Fludarabine and Total Body Irradiation


OBJECTIVES:

Primary

- To assess safety and toxicity of the addition of busulfan added to an established
fludarabine and low-dose total-body irradiation (TBI) conditioning regimen for
non-myeloablative allogeneic transplantation in patients with hematologic malignancies.
(Phase I)

- To assess the non-relapse mortality 1-year after conditioning with busulfan and
fludarabine/TBI in patients with hematologic malignancies at moderate to high risk for
graft rejection and/or relapse of underlying disease. (Phase II)

Secondary

- To assess overall survival 1-year survival. (Phase II)

- To assess the incidence of graft rejection. (Phase II)

- To assess the incidence of grade II-IV acute graft-vs-host disease (GVHD) and chronic
extensive GVHD. (Phase II)

- To assess rates of disease progression and/or relapse-related mortality. (Phase II)

- To determine non-hematologic grade III-IV organ specific toxicity. (Phase II)

OUTLINE:

- Nonmyeloablative-conditioning regimen: Patients receive busulfan IV on day -5 and
fludarabine IV over 30 minutes on days -4 to -2. Patients undergo total body
irradiation on day 0.

- Allogeneic peripheral blood stem cell transplantation (PBSC): Patients undergo donor
PBSC infusion on day 0.

- Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine twice daily
on days -3 to 56 followed by a taper to day 180. Patients with a related stem cell
donor receive oral mycophenolate mofetil twice daily on days 0-28. Patients with an
unrelated stem cell donor receive oral mycophenolate mofetil 3 times daily on days 0-28
followed by a taper twice daily to day 56. Patients with evidence of relapse or
persistent disease may also receive up to 3 donor lymphocyte infusions.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of a hematologic malignancy of 1 of the following high-risk types:

- Acute lymphoblastic leukemia

- Acute myeloid leukemia

- Chronic myelogenous leukemia

- Chronic lymphocytic leukemia

- Myelodysplastic syndromes

- Myeloproliferative disorder

- Multiple myeloma

- Plasma cell dyscrasias

- Non-Hodgkin lymphoma

- Hodgkin disease

PATIENT CHARACTERISTICS:

Performance status

- Karnofsky 50-100%

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- No liver failure

- No cirrhosis with evidence of portal hypertension

- No alcoholic hepatitis

- No esophageal varices

- No chronic hepatitis

- No other liver disease

Renal

- Not specified

Cardiovascular

- LVEF > 35%

- No symptomatic coronary artery disease or cardiac failure requiring therapy

Pulmonary

- DLCO > 30%

- Total lung capacity > 30%

- FEV_1 > 30%

- No supplementary continuous oxygen

Other

- HIV negative

- No active nonhematologic malignancy except localized skin cancer

- No overt organ dysfunction

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

Evaluations at 6 months, 12 months, 18 months and subsequent yearly follow-up's for a total of 5 years.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Richard Maziarz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000447204

NCT ID:

NCT00245037

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Precancerous Condition
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • atypical chronic myeloid leukemia, BCR-ABL negative
  • refractory chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • stage II multiple myeloma
  • stage III multiple myeloma
  • primary systemic amyloidosis
  • refractory multiple myeloma
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • chronic eosinophilic leukemia
  • primary myelofibrosis
  • chronic neutrophilic leukemia
  • essential thrombocythemia
  • polycythemia vera
  • chronic myelomonocytic leukemia
  • acute undifferentiated leukemia
  • extramedullary plasmacytoma
  • isolated plasmacytoma of bone
  • monoclonal gammopathy of undetermined significance
  • stage I multiple myeloma
  • secondary acute myeloid leukemia
  • 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)
  • nodal marginal zone B-cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • splenic marginal zone lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098