Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00295997
• Date of registration: 23/02/2006
• Prospective Registration: No
• Primary sponsor: University of California, San Francisco
• Public title: Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia
• Scientific title: Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia
• Date of first enrolment: May 2005
• Target sample size: 35
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00295997
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Charles A. Linker, MD
• Affiliation: University of California, San Francisco

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 74 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Cancer

Leukemia

Myelodysplastic Syndromes

Chronic Myeloproliferative Disorders

Lymphoma

Multiple Myeloma and Plasma Cell Neoplasm

Myelodysplastic/Myeloproliferative Neoplasms

Intervention(s)

Biological: anti-thymocyte globulin

Biological: filgrastim

Drug: busulfan

Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation

Procedure: allogeneic bone marrow transplantation

Drug: cyclophosphamide

Drug: fludarabine phosphate

Drug: methotrexate

Drug: tacrolimus

Biological: therapeutic allogeneic lymphocytes

Drug: mycophenolate mofetil

Biological: graft-versus-tumor induction therapy

Procedure: peripheral blood stem cell transplantation

Secondary ID(s)

UCSF-01251

UCSF-H5010-19585-05

CDR0000463522

UCSF-2101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)