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Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia


N/A
16 Years
75 Years
Not Enrolling
Both
Acute Myeloid Leukemia, Myelodysplasia, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Multiple Myeloma, NHL, Myeloproliferative Diseases, Chronic Myeloid Leukemia, Renal Cell Carcinoma, Aplastic Anemia

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Trial Information

Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia


Inclusion Criteria:



- <75 years old

- Availability of suitable matched unrelated donor. We will require HLA matching at 9
of 10 loci including HLA A, B, C, DR and DQ. For patients treated at UCSF, typing
will be done in the UCSF Immunogenetics Department. Typing will be done by
high-resolution techniques at the allele level. Donors will be recruited through the
National Marrow Donor Program (NMDP). Donors must meet the standards of NMDP as well
as Institutional standards for donors at the center for which they are being
collected.

- Disease must be stable or responding to therapy. The expected time to disease
progression should be greater than 12 weeks.

- Disease types include:

- Acute myeloid leukemia not expected to be curable with chemotherapy. This will
include patients with high-risk cytogenetics (-7, -7q, -5, -5q, complex, Ph+),
evolution from prior myelodysplasia or AML secondary to prior chemotherapy,
failure to achieve remission, or second or subsequent remission. To ensure
adequate time until disease progression, marrow blasts must be <10%. This may be
achieved using chemotherapy treatment.

- Myelodysplasia with high-risk features. These will include adverse cytogenetics
(-7, -7q, -5, -5q, complex), excess blasts, prior conversion to AML, or severe
cytopenias, with ANC<500uL or platelets <20,000uL. Marrow blasts must be <10%.
This may be achieved using chemotherapy.

- Acute lymphoblastic leukemia not expected to be curable with chemotherapy. This
will include patients with high-risk cytogenetics (Ph+, 11q23 abnormalities, and
monosomy 7), patients requiring more than one induction course to achieve
remission, as well as patients failing to enter remission or in second or
subsequent remission. Marrow blasts must be <10%.

- Chronic lymphocytic leukemia with high-risk features. This will include
refractoriness to initial or subsequent therapy, progression after initial
response to therapy, or prolymphocytic (PLL) morphology.

- Follicular lymphoma with high-risk features. This will include refractoriness to
initial or subsequent therapy, progression after response to initial therapy, or
> or equal 3 IPI risk factors.

- Multiple myeloma, stage II-III. Patients are eligible either at diagnosis or
after initial progression.

- Other lymphomas including diffuse large cell lymphoma, mantle cell lymphoma, or
Hodgkin's disease which as failed to respond to primary therapy, progressed or
recurred after prior therapy.

- Myeloproliferative diseases (myelofibrosis, polycythemia vera essential
thrombocytosis) with evidence of disease acceleration.

- Chronic myeloid leukemia with failure disease control by Imatinib.

- Renal cell carcinoma with metastatic disease

- Aplastic anemia not responsive to immunosuppressive therapy

- Laboratory requirements (within 2 weeks of entry, EF and DLCO within 4 weeks):
--Creatinine ,2.0mg/dL and creatinine clearance >40 mL/min

- Bilirubin <3mg/dL, AST <4x upper limit of normal. Patients with elevated total
bilirubin who are suspected of having Gilbert's Disease will be eligible if the
direct bilirubin is normal.

- Patients with hepatitis C and hepatitis B are eligible if bilirubin and AST meet
above criteria

- Cardiac ejection fraction >30%

- DLCO >40% predicted

- Negative pregnancy test (for females of reproductive age)

- Absence of uncontrolled active infection.

- Prior stem cell (or bone marrow) transplantation is permitted

- Signed informed consent

Exclusion Criteria:

- Active infection requiring ongoing antibiotic treatment

- Poor performance status

- Rapid progression of malignant disease

- Opinion of BMT Committee that autologous transplant would be a preferable form of
treatment

- Organ function below requirements

- Pregnancy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Charles A. Linker, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

UC2101-CC01251

NCT ID:

NCT00513175

Start Date:

October 2001

Completion Date:

November 2007

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplasia
  • Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Multiple Myeloma
  • NHL
  • Myeloproliferative Diseases
  • Chronic Myeloid Leukemia
  • Renal Cell Carcinoma
  • Aplastic Anemia
  • Allogeneic SCT
  • Matched unrelated donors
  • hematologic malignancies
  • renal cell carcinoma
  • aplastic anemia
  • Anemia
  • Anemia, Aplastic
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Follicular
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Hematologic Neoplasms

Name

Location

University of California San FranciscoSan Francisco, California  941104206