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Allogeneic Peripheral Blood Stem Cell Transplantation Using a Non-Myeloablative Preparative Regimen for Patients With Hematologic Malignancies


Phase 2
18 Years
60 Years
Not Enrolling
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

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Trial Information

Allogeneic Peripheral Blood Stem Cell Transplantation Using a Non-Myeloablative Preparative Regimen for Patients With Hematologic Malignancies


OBJECTIVES: I. Determine the effect of nonmyeloablative chemotherapy followed by allogeneic
peripheral blood stem cell transplantation on hematopoietic recovery in patients with
hematologic malignancies. II. Determine the toxicities of this regimen in these patients.
III. Determine the frequency of mixed hematopoietic chimerism in these patients after this
therapy. IV. Determine the efficacy and toxicity of donor leukocyte infusions at relapse in
these patients. V. Determine the response rates and survival of these patients after this
therapy. VI. Determine the immune reconstitution of patients undergoing this therapy.

OUTLINE: Patients receive fludarabine IV over 30 minutes on days -9 to -5, cyclophosphamide
IV over 1 hour on day -5, and antithymocyte globulin IV over 10 hours on days -5 to -2.
Allogeneic peripheral blood stem cells are infused on day 0. Patients who achieve complete
remission (CR) and then relapse or patients who achieve less than a CR before day 60 receive
donor leukocyte infusions (DLI) over 30 minutes. DLI are repeated as necessary for
persistent disease. Patients are followed at 1, 3, and 6 months, then at 1 and 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy for which there is
no standard curative therapy, including, but not limited to: Low grade non-Hodgkin's
lymphoma (NHL) Mantle cell lymphoma Chronic lymphocytic leukemia (stage II-IV)
Myelodysplastic syndrome, including: Refractory anemia (RA) with ringed sideroblasts RA
with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia Multiple
myeloma OR Histologically proven hematologic malignancy that has failed 1 prior therapy OR
is at high risk for relapse, including, but not limited to: Intermediate grade NHL High
grade NHL Hodgkin's disease Acute lymphoblastic lymphoma Acute myelogenous leukemia OR
Histologically proven chronic myelogenous leukemia in chronic or accelerated phase, with
the following risk factors that preclude eligibility for standard allogeneic peripheral
blood stem cell transplantation: Older age Poor performance status Healthy, partially
related HLA 5/6 or 6/6 serologic match donor available A new classification scheme for
adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate", or
"high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 18 to 60 or physiologic 70 Performance status: Karnofsky 0-2
Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than
2.0 mg/dL SGOT and SGPT less than 2 times normal No active hepatitis Renal: Creatinine
less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular:
Ejection fraction greater than 45% OR Cardiac clearance Pulmonary: DLCO at least 50%
predicted Other: No active infection HIV-1, HIV-2, and HTLV-1 negative Not pregnant or
nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation Hematopoetic recovery and toxicities of non-myeloablative allogenic stem cell transplantation

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Todd M. Zimmerman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

9581

NCT ID:

NCT00004145

Start Date:

November 1998

Completion Date:

June 2006

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • refractory chronic lymphocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic 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
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • 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
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637