Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia… (NCT00003816) | Clinical Trial Compass
CompletedPhase 2/3
Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer
United States361 participantsStarted 1998-10-19
Plain-language summary
RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor stem cell helps stop the growth of cancer or abnormal cells. It may also 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. It is not yet known which combination chemotherapy regimen is most effective when given before a donor stem cell transplant in treating aplastic anemia or hematologic cancer.
PURPOSE: This phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given before donor stem cell transplant in treating patients with aplastic anemia or hematologic cancer.
Who can participate
Age range
4 Years – 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.
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following:
* Severe aplastic anemia as defined by either of the following:
* Marrow cellularity (\< 25% \[or 25-50% cellularity with \< 30% of remaining cells hematopoietic in origin\])
* At least 2 of the following abnormal peripheral blood counts:
* Reticulocyte count \< 1% (corrected for hematocrit)
* Platelet count \< 20,000/mm\^3
* Neutrophil count \< 500/mm\^3
* Histologically confirmed hematologic malignancy, including any of the following:
* Acute leukemia
* Resistant or recurrent disease after combination chemotherapy with at least one standard regimen OR in first remission and at high risk of relapse
* Acute myeloid leukemia (AML) (antecedent myelodysplastic syndromes \[MDS\], secondary AML, or high-risk cytogenetic abnormalities)
* Acute lymphoblastic leukemia (ALL) (high-risk cytogenetic abnormalities)
* Chronic myeloid leukemia (CML)
* Chronic phase, accelerated phase, or blast phase
* Myeloproliferative disorders or MDS, including any of the following:
* Myelofibrosis
* Polycythemia vera\*
* Essential thrombocythemia\*
* Refractory anemia
* Refractory anemia with excess blasts
* Refractory anemia with excess blasts in transformation
* Chronic myelomonocytic leukemia NOTE: \* Only if transformed to AML or MDS
* Lymphoproliferative disease
* Recurrent or persistent, symptomatic disease aft…
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.