Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
Completed · Not applicable
Conditions studied: Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
In brief
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or 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 make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, mycophenolate mofetil, and antithymocyte globulin before and after transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer or abnormal cells as not belonging in the patient's body and destroy them (graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with hematologic cancer or other diseases.
Key facts
- Study ID
- NCT00453206
- Run by
- Wake Forest University Health Sciences
- People needed
- 66
- Starts
- 2007-02-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2018-09-10
Who can join
Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed hematological disease, including any of the following:
- Chronic lymphocytic leukemia
- Absolute lymphocytosis > 5,000/µL
- Morphologically mature lymphocytes with < 55% prolymphocytes
- Lymphocyte phenotype with expression of CD19 and CD5
- Absence of CD23 expression allowed provided disease is morphologically distinguished from mantle cell lymphoma
- Prolymphocytic leukemia
- Absolute lymphocytosis > 5,000/µL
- Morphologically mature lymphocytes with > 55% prolymphocytes
- Non-Hodgkin's or Hodgkin's lymphoma
- Any WHO classification histologic subtype
- Diagnosis by core biopsy allowed provided there is adequate tissue for diagnosis and immunophenotyping
- Diagnosis by bone marrow biopsy not acceptable for follicular lymphomas
- Multiple myeloma
- Has received ≥ 1 prior treatment regimen
- Has a partial response or greater by the Blade Criteria
- Patients who achieved complete remission are eligible
- Acute myeloid leukemia
- Documented control (i.e., < 10% bone marrow blasts and no circulating blasts)
- Myelodysplastic syndromes
- Documented disease as defined by WHO or French-American-British Cooperative group criteria
- Chronic myelogenous leukemia
- Patients with atypical chronic myelogenous leukemia (i.e., absent Philadelphia chromosome) are eligible
- Polycythemia vera
- Documented disease as defined by WHO criteria (i.e., A1 + A2, and any other category A, OR A1 + A2, and any 2 category B):
You may not qualify if…
- Uncontrolled diabetes mellitus
- Active serious infection
- Known hypersensitivity to E. coli-derived products
- Known HIV positivity
- History of another malignancy*, meeting the following criteria:
- Non-skin malignancy or melanoma within the past 5 years
- Concomitant malignancy that has not been curatively treated
- NOTE: *However, cancer survivors who have undergone potentially curative therapy for a prior malignancy at least 5 years before enrollment and are deemed at low risk of < 30% for recurrence by their treating physicians is considered
- Pregnant or nursing
Where it is running
- Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.