View Clinical Trial (Medical Research Study)
T-Regulatory Cell Kinetics for Patients Receiving Alemtuzumab and Undergoing Stem Cell Transplantation From HLA Mismatched-related or HLA Matched- or Mismatched- Unrelated Donors
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Chronic Myeloproliferative Disorders - Leukemia - Lymphoma - Myelodysplastic Syndromes - Myelodysplastic/Myeloproliferative Neoplasms |
| Purpose: |
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RATIONALE: Giving chemotherapy, monoclonal antibody therapy, and total-body irradiation
before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It
also helps stop the patient's immune system from rejecting the donor's stem cells. When the
healthy stem cells from a donor are infused into the patient they may help the patient's
bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes
the transplanted cells from a donor can also make an immune response against the body's
normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from
happening.
PURPOSE: This clinical trial is studying T-cell recovery in patients with leukemia, advanced
lymphoma, myelodysplastic syndrome, or myeloproliferative disorder receiving alemtuzumab and
undergoing donor stem cell transplant.
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| Study Summary: |
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OBJECTIVES:
Primary
- To define the biologic recovery and behavior of T-regulatory cells in patients
undergoing stem cell transplantation.
- To determine if the administration of alemtuzumab as part of conditioning therapy to
patients undergoing stem cell transplantation from mismatched-related donors or from
matched-unrelated donors permits T-regulatory cell recovery.
OUTLINE: This is a multicenter study.
- Stem cell transplantation conditioning regimen: Patients receive cytarabine IV every 12
hours for 6 doses starting on day -8*, cyclophosphamide IV once daily on days -7 and
-6, alemtuzumab IV on days -4 to -1, and undergo total body irradiation (TBI) twice
daily on days -4 to -1 (total of 8 fractions). Patients with CNS disease will receive
additional irradiation to the craniospinal axis.
NOTE: *Patients with T-cell lymphoma do not receive cytarabine.
- Stem cell transplantation: Patients undergo stem cell transplantation on day 0.
- Graft-versus-host-disease (GVHD) prevention: Patients receive tacrolimus IV beginning
on day -2, and continuing according to institutional guidelines, followed by a taper.
Patients also receive methotrexate IV on days +1, +3, +6, and +11.
Blood or bone marrow samples will be collected periodically for regulatory T-cell assay.
After completion of study treatment, patients are followed once a month for 6 months, at 9
months, and at 1, 2, and 3 years.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Acute or chronic leukemia
- Advanced Hodgkin or non-Hodgkin lymphoma
- Myelodysplastic/myeloproliferative disease
- Unlikely to be cured by standard chemotherapy treatments
- Relapsed after standard chemotherapy treatments
- In first remission with unfavorable prognostic features
- Must have either a one HLA antigen mismatched-related donor or an HLA
matched-unrelated donor using the standard 6 HLA antigen profile (HLA class I, A and
B, and HLA class II, DRB1)
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 70-100% or Lansky PS 50-100%
- Life expectancy > 6 weeks unless limited by leukemia
- No evidence of symptomatic cardiac dysfunction by echocardiogram (i.e., shortening
fraction < 20%)
- Creatinine ≤ 3 times normal for age
- FVC ≥ 40% of predicted
- Direct bilirubin ≤ 3 mg/dL
- AST ≤ 500 IU/L
- No severe personality disorder or mental illness
- No severe infection that, in the estimation of the principal investigator, prohibits
the use of ablative chemotherapy
- No documented HIV positivity
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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| NCT ID: |
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NCT00647010 |
| Primary Contact: |
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Study Chair
Robert Krance, MD
Baylor College of Medicine
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| Backup Contact: |
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N/A |
| Location Contact: |
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Houston, Texas 77030
United States
Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor
Phone: 713-798-1297
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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