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Chronic Myeloproliferative DisordersNCT00295997

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

A study testing anti-thymocyte globulin, filgrastim and graft-versus-tumor induction therapy in people with Chronic Myeloproliferative Disorders and Kidney Cancer, run by University of California, San Francisco at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. Read more about this study

Who is it for?
Ages Up to 74 years
What is being tested?
anti-thymocyte globulin, filgrastim and graft-versus-tumor induction therapy
Type of treatment
Surgery or procedure
How many people
35 participants
Where
2 sitesUnited States
Study dates
May 2005to not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 74 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well a donor stem cell transplant works in treating patients with hematologic cancer, metastatic kidney cancer, or aplastic anemia.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the treatment-related mortality (TRM) rate at 100 days in patients with hematologic malignancy, metastatic renal cell carcinoma, or aplastic anemia undergoing nonmyeloablative allogeneic stem cell transplantation using matched unrelated donors.

Secondary

  • Determine the TRM at 12 months in patients treated with this regimen.
  • Determine the 6-month engraftment rate in patients treated with this regimen.
  • Determine 1-year overall survival of patients treated with this regimen.

OUTLINE:

  • Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan* IV over 6 hours on days -4 and -3, and anti-thymocyte globulin IV over 6-10 hours on days -4 to -1.

NOTE: *Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to -3 instead of busulfan.

  • Allogeneic stem cell reinfusion: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover.
  • Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally twice daily or IV continuously beginning on day -2 and continuing for approximately for 6-12 months after transplantation. Patients also receive mycophenolate mofetil orally or IV twice daily on days 0 to 60 and methotrexate IV on days 1, 3, 6, and 11**.

NOTE: **Patients with aplastic anemia receive methotrexate IV on days 1, 3, and 6 (not day 11).

  • Donor lymphocyte infusion (DLI): After day 180, patients with no evidence of active GVHD may receive DLI. A second DLI may be infused > 8 weeks after the first in the absence of disease response or GVHD.

After completion of study treatment, patients are followed periodically for at least 2 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Being tested
anti-thymocyte globulin, filgrastim, graft-versus-tumor induction therapy, therapeutic allogeneic lymphocytes, busulfan
Keywords
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, atypical chronic myeloid leukemia, BCR-ABL1 negative, blastic phase chronic myelogenous leukemia, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood chronic myelogenous leukemia, chronic eosinophilic leukemia, primary myelofibrosis, chronic myelomonocytic leukemia, chronic neutrophilic leukemia, chronic phase chronic myelogenous leukemia, de novo myelodysplastic syndromes, essential thrombocythemia, juvenile myelomonocytic leukemia
Medical subject headings
Myeloproliferative Disorders, Kidney Neoplasms, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2006 (estimated)
  2. Study startMay 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295997
Sponsor's protocol ID
CDR0000463522
Other IDs
UCSF-01251, UCSF-H5010-19585-05, UCSF-2101
Status last verified
Apr 2007
First submitted
23 Feb 2006
Last updated
6 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing anti-thymocyte globulin, filgrastim and graft-versus-tumor induction therapy in people with Chronic Myeloproliferative Disorders and Kidney Cancer, run by University of California, San Francisco at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.

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