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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 11, 2003 | ||||||||
| Last Updated Date | July 29, 2009 | ||||||||
| Start Date ICMJE | August 2000 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00058825 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Stem Cell Transplant for Hematologic Diseases and Renal Cell Cancer | ||||||||
| Official Title ICMJE | Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Diseases and Renal Cell Carcinoma, Using Haploidentical Family Donors and Sub-Myeloablative Conditioning With Campath 1H | ||||||||
| Brief Summary | Usually, patients are given very strong doses of chemotherapy (drugs which kill cancer cells) prior to receiving a stem cell transplant. However some patients, due to complications with their condition, may have a high risk of getting possibly life-threatening treatment-related side effects. Recently, investigators have developed an increased interest in using chemotherapy that does not cause as many side effects (less toxic) before patients receive a transplant. The major problem with this type of chemotherapy is that there is a greater chance of having graft versus host disease (GVHD). GVHD occurs when the new stem cells from the donor (graft) recognizes that the body tissues of the patient (host) are different. When this happens cells in the graft may attack the host organs, primarily the skin, the liver and the intestines. This research study adds CAMPATH 1H to a low-dose chemotherapy regimen (the pattern that the treatment is administered) followed by allogeneic stem cell transplantation. This research study will help us learn if the addition of CAMPATH 1H to the pre-transplant low dose chemotherapy will decrease the known side effects from an allogeneic stem cell transplantation, while providing a curative treatment to patients with blood disorders and renal cell cancer. |
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| Detailed Description | Before treatment begins, stem cells will be collected from the donor's blood or bone marrow. The stem cells will be collected and frozen before we start to give the patient chemotherapy. After admission to the hospital, patients will receive total body irradiation (very strong type of x-rays that kill cells in the bone marrow), Fludarabine and Campath 1H prior to the Stem cell transplant (infusion of the donors stem cells). Starting 7 days after the transplant, the patient will be given G-CSF by subcutaneous injection until a blood test shows that granulocytes (a type of white blood cell) are more than 1000/ul. This is to help increase blood counts. After transplantation, the patient will have several evaluations at different times. These are standard evaluations and tests done for any patient who has received a stem cell transplant as part of routine clinical monitoring: We will also be looking at the patient's immune function (how the body protects itself to prevent and fight infections and diseases). To do this blood tests will be done at regular intervals (every 3 to 6 months) for 2 years. Depending on how well the donors stem cells work in the body after the transplant, the patient may receive one or more Donor Leukocyte Infusions (DLI). This is when leukocytes (a type of white blood cell) collected from the same donor that provided the stem cells are given to the patient through a central line into a vein. |
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| Study Phase | Phase I, Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Hematologic Malignancies | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Eligibility Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00058825 | ||||||||
| Responsible Party | George Carrum, MD, Baylor College of Medicine | ||||||||
| Study ID Numbers ICMJE | H8713 | ||||||||
| Study Sponsor ICMJE | Baylor College of Medicine | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Baylor College of Medicine | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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