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Non-Myeloablative Allogeneic Bone Marrow Transplant for Hematologic Malignancies


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

Thank you

Trial Information

Non-Myeloablative Allogeneic Bone Marrow Transplant for Hematologic Malignancies


OBJECTIVES: I. Determine whether sustained engraftment of HLA identical sibling marrow can
be achieved in patients treated with total body irradiation before transplant and tacrolimus
and mycophenolate mofetil after transplant. II. Document the nonhematologic toxicities of
this regimen. III. Characterize immune reconstitution of patients during this treatment
regimen. IV. Document the incidence of aplasia and graft-versus-host disease associated with
donor leukocyte infusions when administered after this regimen.

OUTLINE: Patients receive total body irradiation in a single fraction on day -1. Tacrolimus
is given orally twice per day on days -1 to 50. Mycophenolate mofetil is given orally on day
0 and twice per day on days 1 to 28. Patients receive donor bone marrow infusion on day 0.
Patients are evaluated on days 56, 180, 292, and 365. If there is donor engraftment, donor
chimerism is less than 80%, there is no active graft-versus-host disease, no disease
progression, less than 50% decrease in donor cell chimerism from last measurement, and the
patient is not taking immunosuppressive agents, then donor leukocyte infusions are
administered on days 70, 194, and 306. Patients are followed annually for 5 years.

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

Inclusion Criteria


DISEASE CHARACTERISTICS: Must have a 6 antigen HLA identical related donor and one of the
following diseases: -Acute myelogenous leukemia in high risk first complete remission or
second or greater complete remission -Acute lymphocytic leukemia in high risk first
complete remission or second or greater remission -Chronic myelogenous leukemia in chronic
phase -Indolent non-Hodgkin's lymphoma (NHL) or aggressive NHL in complete or partial
remission, not eligible for autologous bone marrow transplant (ABMT) -Multiple myeloma in
complete or partial response -Myelodysplastic syndrome -Stage III or IV chronic
lymphocytic leukemia -Hodgkin's disease after first complete remission Patients must also
have one of the following high risk features: -Age 55-70 -Age 18-54 must have one of the
following conditions: LVEF 35-44% FEV1 or FVC 40-49% Bilirubin 2.1-3.0 mg/dL, AST 71-175,
or ALT 81-200 Creatinine 2.1-3.0 mg/dL Disease recurrence less than 1 year after ABMT
Between 18 to 24 months of prior chemotherapy (12 to 24 months for multiple myeloma)

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3.1 mg/dL Renal:
Creatinine less than 3.1 mg/dL Cardiovascular: LVEF at least 35% Pulmonary: FEV1 and FVC
at least 40% of predicted (60% for patients who have received thoracic or mantle
radiotherapy) Other: Not pregnant Fertile patients must use effective contraception Not
HIV positive

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ephraim J. Fuchs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066639, J9845

NCT ID:

NCT00003572

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • Waldenstrom macroglobulinemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult Burkitt lymphoma
  • 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
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • stage I mantle cell lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous 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 adult diffuse small cleaved cell 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
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic 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

Johns Hopkins Oncology CenterBaltimore, Maryland  21287