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Main
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Note: This record shows only 22 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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12 December 2020 |
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Main ID: |
NCT01499147 |
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Date of registration:
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23/11/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
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Scientific title:
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Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies |
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Date of first enrolment:
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February 2000 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01499147 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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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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Damiano Rondelli, 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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University of Illinois at Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with the following diseases:
- Acute myeloid or lymphocytic leukemia in first remission at standard or high-risk
for recurrence.
- Acute leukemia in greater than or equal to second remission, or with early
relapse, or partial remission.
- Chronic myelogenous leukemia in accelerated phase or blast-crisis.
- Chronic myelogenous leukemia in chronic phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease
- Multiple myeloma.
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
- Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor
prognostic features.
- Severe aplastic anemia after failure of immunosuppressive therapy.
- Age 10-65 years.
- Zubrod performance status less than or equal to 2.
- Adequate cardiac and pulmonary function. Patients with decreased LVEF < 40% or DLCO <
50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on
this protocol.
- Patient or guardian able to sign informed consent.
Exclusion Criteria:
- Life expectancy is severely limited by concomitant illness.
- Serum creatinine greater than 1.5 mg/dL or Creatinine Clearance less than 50 ml/min .
- Serum bilirubin greater than or equal to 2.0 mg/dl, SGPT greater than 3 x upper limit
of normal
- Evidence of chronic active hepatitis or cirrhosis
- HIV-positive
- Patient is pregnant
Age minimum:
10 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hodgkin's Disease
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Acute Leukemia
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Aplastic Anemia
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Chronic Myelogenous Leukemia
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Lymphocytic Leukemia
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Multiple Myeloma
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Myelofibrosis
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Acute Myeloid Leukemia
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Myeloproliferative Disorder
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Malignant Lymphoma
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Polycythemia Vera
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Intervention(s)
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Drug: ATG
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Drug: fludarabine/ melphalan
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Drug: fludarabine/busulfan
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Primary Outcome(s)
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Number of Participants With Engraftment.
[Time Frame: Up to 30 days post-transplant]
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Secondary Outcome(s)
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Time to ANC and Platelet Engraftment
[Time Frame: Up to 30 days post-transplant]
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Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).
[Time Frame: Up to 100 days post-transplant (acute GVHD).]
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Participants With 100 Day Transplant-related Mortality.
[Time Frame: Up to 100 days post-transplant.]
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Secondary ID(s)
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2000-0117
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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