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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00513175
First received: August 7, 2007
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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
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 Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 44
Study Start Date: October 2001
Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00513175     History of Changes
Other Study ID Numbers: UC2101-CC01251
Study First Received: August 7, 2007
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
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
Hematologic Diseases
Bone Marrow Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases

ClinicalTrials.gov processed this record on August 28, 2014