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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 May 2013 |
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Main ID: |
NCT00208962 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Allogeneic Cell Therapy for Adults With Hematologic Malignancies
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Scientific title:
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Allogeneic Cell Therapy for Adults With Hematologic Malignancies |
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Date of first enrolment:
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September 1998 |
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Target sample size:
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40 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00208962 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Amelia Langston, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University Winship Cancer Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- To be eligible as a recipient for this study, patients must have CML in chronic phase
and be older than 60 years of age, have advanced MDS and be over 60 years of age,
have CLL and be over 50 years of age, or have low grade lymphoma and be over 50 years
of age. HLA typing of the recipient's family will be used to identify potential
donors. Please contact study nurse for additional eligibility criteria. Final
eligibility will be determined by the health professionals conducting this clinical
trial.
Exclusion Criteria:
- Patients with an active, invasive/systemic fungal infection and patients with
serologic evidence of antibodies to HIV I/II will be excluded from participating as
recipients in this study. Additional exclusion factors include: patients who are
pregnant or lactating, those with active CNS malignant disease, and patients whose
life expectancy is limited by diseases other than the disease for which the
transplant is being performed. Please contact study nurse for additional
ineligibility criteria. Final eligibility will be determined by the health
professionals conducting this clinical trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hematologic Diseases
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Intervention(s)
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Procedure: chemotherapy and blood stem cell transplantation
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Primary Outcome(s)
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Determine if conventional dose chemotherapy followed by allogeneic PBSC transplant and short course immunosuppression provide stable, sustained mixed donor-host chimerism.
[Time Frame: 100 days]
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Secondary Outcome(s)
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Determine degree of donor-derived hematopoiesis and disease status on day +21, +40, +90, +140, and 180; overall survival and disease free survival at 6 months.
[Time Frame: 6 months]
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Secondary ID(s)
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0466-1998
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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