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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

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ClinicalTrials.gov Identifier: NCT00513175
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : November 9, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:
The primary objective of this study is to examine transplant related mortality (TRM) at 100 days <30%. A TRM of >50% is considered unacceptable. This study also seeks a TRM at 12 months that is <50%, engraftment >90% (defined as donor cells >80% at 6 months), and 1 year overall survival >50%.

Condition or disease
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

Study Design

Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia
Study Start Date : October 2001
Study Completion Date : November 2007


Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513175


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Charles A. Linker, M.D. University of California, San Francisco
More Information

ClinicalTrials.gov Identifier: NCT00513175     History of Changes
Other Study ID Numbers: UC2101-CC01251
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by University of California, San Francisco:
Allogeneic SCT
Matched unrelated donors
hematologic malignancies
renal cell carcinoma
aplastic anemia

Additional relevant MeSH terms:
Leukemia
Carcinoma
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Multiple Myeloma
Lymphoma, Follicular
Anemia
Neoplasms
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Carcinoma, Renal Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Anemia, Aplastic
Myeloproliferative Disorders
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases