Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Seconda… (NCT01118013) | Clinical Trial Compass
TerminatedPhase 2
Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant
United States6 participantsStarted 2010-12
Plain-language summary
RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called 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 relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .
Who can participate
Age range
69 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:
* Histologically confirmed hematologic malignancies:
* Chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL)
* Absolute lymphocytosis of \> 5,000/μL
* Lymphocytes must appear morphologically mature with \< 55% prolymphocytes (CLL)
* Patients with \> 55% prolymphocytes are considered as having PLL
* Lymphocyte phenotype with expression of CD20, CD19, and CD5 (CLL)
* Non-Hodgkin lymphoma
* Any WHO classification of histologic subtype
* Core biopsies acceptable for primary diagnosis and immunophenotyping
* Bone marrow biopsies as sole means of diagnosis not allowed for follicular lymphoma
* Hodgkin lymphoma
* Any WHO classification of histologic subtype
* Core biopsies acceptable for primary diagnosis and immunophenotyping
* Bone marrow biopsy is required
* Multiple myeloma
* Patients must have active disease requiring treatment (Durie-Salmon stage I-III)
* Acute myeloid leukemia
* Must have \< 10% bone marrow blasts and no circulating blasts
* Myelodysplastic syndrome (MDS)
* MDS as define by WHO criteria
* Must have \< 10% marrow blasts
* Relapsed or progressive disease or myelodysplasia ≥ 6 months after prior high-dose chemotherapy with autologous hematopoietic cell support
* Prior syngeneic transplantation allowed
* Healthy donor meeting one of the following criteria:
* HLA-identical sibling (6/6)
* Serologic typing for class I (A, B) and molecular…
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
Event-free Survival (EFS)
Timeframe: Duration of study (up to 5.5 years)
2
Comparison of EFS Distribution to That of CALGB-100002