Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored.

Clinical Trial Description

- In order to undergo transplant procedure, patients will be admitted to the hospital for approximately 10-14 days.

- To prepare patient's bone marrow to accept donor stem cells, they will receive fludarabine and busulfex. Fludarabine will be given intravenously once daily for 4 days. Busulfex will be given once daily for the same 4 days.

- One day before patients receive busulfex and fludarabine, they will also be given alemtuzumab intravenously once daily for 5 days.

- Three days after the end of chemotherapy, patients will receive the infusion of donor stem cells.

- If patients have thalassemia, they will receive subcutaneous injections of filgrastim starting on day one after the donor stem cell transfusion and will continue receiving filgrastim every day until it appears that the donor stem cells have been accepted. If the patient has sickle cell disease, filgrastim will not be given,

- Additional drugs will be given to help prevent infection (i.e. antibiotics).

- After stem cell infusion patients will be examined and have blood tests weekly for 1 month. Bone marrow biopsies, and blood work will also be performed 1 month, 3 months, 6 months and 1 year after stem cell infusion.

- Patients will be on the study for about 12 months. After study is completed progress will be monitored on an annual basis. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00153985
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact
Status	Completed
Phase	Phase 2
Start date	March 2004
Completion date	July 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms