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Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia


N/A
N/A
74 Years
Open (Enrolling)
Both
Chronic Myeloproliferative Disorders, Kidney Cancer, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia


OBJECTIVES:

Primary

- Determine the treatment-related mortality (TRM) rate at 100 days in patients with
hematologic malignancy, metastatic renal cell carcinoma, or aplastic anemia undergoing
nonmyeloablative allogeneic stem cell transplantation using matched unrelated donors.

Secondary

- Determine the TRM at 12 months in patients treated with this regimen.

- Determine the 6-month engraftment rate in patients treated with this regimen.

- Determine 1-year overall survival of patients treated with this regimen.

OUTLINE:

- Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes
on days -7 to -3, busulfan* IV over 6 hours on days -4 and -3, and anti-thymocyte
globulin IV over 6-10 hours on days -4 to -1.

NOTE: *Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to
-3 instead of busulfan.

- Allogeneic stem cell reinfusion: Patients undergo allogeneic bone marrow or peripheral
blood stem cell transplantation on day 0. Patients then receive filgrastim (G-CSF)
subcutaneously daily beginning on day 7 and continuing until blood counts recover.

- Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally twice
daily or IV continuously beginning on day -2 and continuing for approximately for 6-12
months after transplantation. Patients also receive mycophenolate mofetil orally or IV
twice daily on days 0 to 60 and methotrexate IV on days 1, 3, 6, and 11**.

NOTE: **Patients with aplastic anemia receive methotrexate IV on days 1, 3, and 6 (not day
11).

- Donor lymphocyte infusion (DLI): After day 180, patients with no evidence of active
GVHD may receive DLI. A second DLI may be infused > 8 weeks after the first in the
absence of disease response or GVHD.

After completion of study treatment, patients are followed periodically for at least 2
years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Aplastic anemia not responsive to immunosuppressive therapy

- Metastatic renal cell carcinoma

- Hematologic malignancy, including any of the following:

- Acute myeloid leukemia (AML)* not curable with chemotherapy and meeting any
of the following criteria:

- AML with high-risk cytogenetic abnormalities (e.g., -7, -7q, -5, -5q,
complex, Philadelphia chromosome-positive [Ph+])

- AML evolved from prior myelodysplasia

- AML secondary to prior chemotherapy

- Failed to achieve remission

- In second or subsequent remission NOTE: *Marrow blasts < 10%- can be
achieved by chemotherapy

- Myelodysplasia* with any of the following high-risk features:

- Adverse cytogenetics (-7, 7q, -5, -5q, complex)

- Excess blasts

- Prior conversion to AML

- Severe cytopenias with absolute neutrophil count < 500/mm^3 or
platelet count < 20,000/mm^3 NOTE: *Marrow blasts < 10%- can be
achieved by chemotherapy

- Acute lymphoblastic leukemia (ALL)* not curable with chemotherapy and
meeting any of the following criteria:

- High-risk cytogenetics (Ph+, 11q23 abnormalities, monosomy 7)

- More than 1 induction course required to achieve remission

- Failed to enter remission

- In second or subsequent remission NOTE: *Marrow blasts < 10 %

- Chronic lymphocytic leukemia (CLL) with high-risk features, including any
of the following:

- Refractory to initial or subsequent therapy

- Progression after initial response to therapy

- Prolymphocytic morphology

- Follicular lymphoma with any of the following high-risk features:

- Refractory to initial or subsequent therapy

- Progression after response to initial therapy

- Has ≥ 3 International Prognostic Index (IPI) risk factors

- Multiple myeloma

- Stage II-III disease confirmed at diagnosis or after initial
progression

- Other lymphoma that has failed to respond to primary therapy, progressed,
or recurred after prior therapy, including any of the following:

- Diffuse large cell lymphoma

- Mantle cell lymphoma

- Hodgkin's lymphoma

- Myeloproliferative disease with evidence of disease acceleration, including
any of the following:

- Myelofibrosis

- Polycythemia vera

- Essential thrombocythemia

- Chronic myeloid leukemia (CML) that failed to be controlled by imatinib
mesylate

- Disease must be stable or responding to therapy

- No rapid progression of malignant disease

- Expected time to disease progression > 12 weeks

- Not eligible for autologous stem cell transplantation

- Matched unrelated donor available

- 9/10 HLA matched, including HLA-A, -B, -C, -DR, and -DQ

PATIENT CHARACTERISTICS:

- Creatinine < 2.0 mg/dL

- Creatinine clearance > 40 mL/min

- Bilirubin < 3 mg/dL

- Elevated total bilirubin due to Gilbert's disease allowed if direct bilirubin is
normal

- AST < 4 times upper limit of normal

- Hepatitis C or B allowed provided bilirubin and AST are normal

- Cardiac ejection fraction > 30%

- DLCO > 40% of predicted

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled active infection requiring ongoing antibiotic treatment

- No poor performance status

- No poor organ function

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Prior stem cell or bone marrow transplantation allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Charles A. Linker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000463522

NCT ID:

NCT00295997

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • 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)
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • blastic phase chronic myelogenous leukemia
  • childhood acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood chronic myelogenous leukemia
  • chronic eosinophilic leukemia
  • primary myelofibrosis
  • chronic myelomonocytic leukemia
  • chronic neutrophilic leukemia
  • chronic phase chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • essential thrombocythemia
  • juvenile myelomonocytic leukemia
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • polycythemia vera
  • previously treated myelodysplastic syndromes
  • recurrent adult acute myeloid leukemia
  • prolymphocytic leukemia
  • recurrent adult Hodgkin lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent childhood large cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • refractory chronic lymphocytic leukemia
  • refractory multiple myeloma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • stage II multiple myeloma
  • stage III chronic lymphocytic leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III multiple myeloma
  • stage IV chronic lymphocytic leukemia
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • childhood myelodysplastic syndromes
  • Anemia, Aplastic
  • Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096