NCT00544115Active, not recruitingPhase 2
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell 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, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating patients with advanced hematologic cancer or other disorders.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 260 (actual)
- First submitted
- 13 Oct 2007
- Start date
- 16 Oct 2001
- Primary completion date
- 13 Mar 2007
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Acute lymphoblastic leukaemia, Diffuse large B-cell lymphoma, Myeloproliferative neoplasms, Follicular lymphoma, Hodgkin lymphoma, Chronic myeloid leukaemia, Myelodysplastic syndromes, Mantle cell lymphoma, Chronic lymphocytic leukaemia, Multiple myeloma, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT00544115
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 260
- From 16 Oct 2001 to the primary completion date, 13 Mar 2007
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 0 years to 120 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.