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

NCT00513175 | Completed DMC

• 1 other identifier: UC2101-CC01251
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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%.

Conditions

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

Keywords

Allogeneic SCT; Matched unrelated donors; hematologic malignancies; renal cell carcinoma; aplastic anemia

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia

You may qualify if:

• \<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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Anemia, Refractory, with Excess of Blasts; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular; Multiple Myeloma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Carcinoma, Renal Cell; Anemia, Aplastic; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Myeloproliferative Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Bone Marrow Failure Disorders

Study Officials

• Charles A. Linker, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: October 1, 2001
• Study Completion: November 1, 2007
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

US (1)