Donor stem cell transplant shows promise for tough blood cancers
NCT ID NCT00544115
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a stem cell transplant from a matched unrelated donor for people with advanced blood cancers or blood disorders. Patients get chemotherapy and radiation before the transplant to prepare their body, then take drugs to prevent the donor cells from attacking their own body. The goal is to see how well the transplant works and how long patients survive, but lifelong medication may be needed to manage side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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260 people
The number who actually took part.
- Started
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Oct 2001
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
DISEASE CHARACTERISTICS: * Diagnosis of one of the following: * Acute lymphocytic leukemia (ALL), meeting one of the following criteria: * In first relapse or beyond * High-risk ALL, defined by any of the following: * Hypoploidy (≤ 44 chromosomes) * Pseudodiploidy with translocations or molecular evidence of t(9;22), 11q23, or t(8;14), excluding B-cell ALL * Elevated WBC at presentation (WBC \> 20,000/mm³ \[for patients \> 18 years of age\]; WBC \> 200,000/mm³ \[for patients 12-18 years of age\]) * Acute myeloid leukemia (AML), meeting one of the following criteria: * In first complete remission * Failed to achieve remission * In first relapse or beyond * Secondary AML (\> 30% blasts in marrow aspirate) * Should receive induction chemotherapy to obtain remission, if possible, before transplant * Chronic myelogenous leukemia, meeting one of the following criteria: * In first or second chronic phase or accelerated phase * In blast crisis, defined as \> 30% promyelocytes plus blasts in the bone marrow * Myelodysplastic syndromes, including any of the following: * Refractory anemia with excess blasts (RAEB) * Chronic myelomonocytic leukemia * RAEB in transformation * Refractory non-Hodgkin lymphoma, chronic lymphocytic leukemia, Hodgkin lymphoma, or multiple myeloma * Received and failed front-line therapy, high-dose therapy and autologous stem cell transplantation, or salvage therapy * Myeloproliferative disorders/myelofibrosis may be allowed on a case by case basis * Severe aplastic anemia, paroxysmal nocturnal hemoglobinuria, or any other hematologic disorder requiring transplantation * Patients \> 55 years of age with hematologic diseases treatable by allogeneic stem cell transplantation who are not eligible for IRB 99190 are eligible * No uncontrolled CNS involvement of disease * No matched (6/6) related donor available * HLA-identical unrelated donor available * HLA-phenotypically identical for HLA-A and HLA-B alleles and identical for DRB1 alleles by DNA typing for both class I and class II antigens * Allele mismatch for HLA class I (i.e., B 2701 vs B 2702) allowed if no alternative donors * Allele mismatch for class II (i.e., DRB1 0401 vs 0402) or minor mismatch for class I cross reactive group (CREG) (i.e., A 2 vs A 28) allowed in patients ≤ 35 years of age requiring urgent transplant PATIENT CHARACTERISTICS: * Karnofsky performance status 50-100% * Life expectancy \> 8 weeks * LVEF ≥ 45% at rest * AST ≤ 2 times normal (unless liver function abnormality is due to underlying disease) * Total bilirubin \< 1.5 times normal (unless liver function abnormality is due to underlying disease) * Creatinine ≤ 1.5 times normal OR creatinine clearance ≥ 60 mL/min * DLCO ≥ 40% of predicted (corrected for hemoglobin) * No coexisting medical problem that would significantly increase the risk of the transplant procedure * HIV negative * Not pregnant PRIOR CONCURRENT THERAPY: * See Disease Characteristics
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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