Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases (NCT00453206) | Clinical Trial Compass
CompletedNot Applicable
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases
United States66 participantsStarted 2007-02
Plain-language summary
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.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 + A…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment-related Mortality Within the First 6 Months After Transplantation