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NCT00544115 · REGISTRY CONDITION SEARCH

Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-06-02

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Neutrophil Engraftment - The Days Till ANC Recovery

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outcome · POSTED

Two-year Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
0 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
    intervention Names
    1. Drug: cyclophosphamide
    2. Drug: cyclosporine
    3. Drug: methotrexate
    4. Drug: mycophenolate mofetil
    5. Drug: sirolimus
    6. Drug: tacrolimus
    7. Procedure: allogeneic hematopoietic stem cell transplantation
    8. Procedure: peripheral blood stem cell transplantation
    9. Radiation: total-body irradiation
    label
    Regimen I
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
    intervention Names
    1. Drug: busulfan
    2. Drug: cyclophosphamide
    3. Drug: cyclosporine
    4. Drug: methotrexate
    5. Drug: mycophenolate mofetil
    6. Drug: sirolimus
    7. Drug: tacrolimus
    8. Procedure: allogeneic hematopoietic stem cell transplantation
    9. Procedure: peripheral blood stem cell transplantation
    label
    Regimen II
    type
    ACTIVE_COMPARATOR
  3. description
    Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
    intervention Names
    1. Drug: cyclosporine
    2. Drug: etoposide
    3. Drug: methotrexate
    4. Drug: mycophenolate mofetil
    5. Drug: sirolimus
    6. Drug: tacrolimus
    7. Procedure: allogeneic hematopoietic stem cell transplantation
    8. Procedure: peripheral blood stem cell transplantation
    9. Radiation: total-body irradiation
    label
    Regimen III
    type
    ACTIVE_COMPARATOR
  4. description
    Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
    intervention Names
    1. Drug: cyclosporine
    2. Drug: fludarabine phosphate
    3. Drug: melphalan
    4. Drug: methotrexate
    5. Drug: mycophenolate mofetil
    6. Drug: sirolimus
    7. Drug: tacrolimus
    8. Procedure: allogeneic hematopoietic stem cell transplantation
    9. Procedure: peripheral blood stem cell transplantation
    label
    Regimen IV
    type
    ACTIVE_COMPARATOR
  5. description
    Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
    intervention Names
    1. Drug: cyclosporine
    2. Drug: fludarabine phosphate
    3. Drug: methotrexate
    4. Drug: mycophenolate mofetil
    5. Drug: sirolimus
    6. Drug: tacrolimus
    7. Procedure: allogeneic hematopoietic stem cell transplantation
    8. Procedure: peripheral blood stem cell transplantation
    9. Radiation: total-body irradiation
    label
    Regimen V
    type
    ACTIVE_COMPARATOR
  6. description
    Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
    intervention Names
    1. Drug: busulfan
    2. Drug: cyclosporine
    3. Drug: fludarabine phosphate
    4. Drug: methotrexate
    5. Drug: mycophenolate mofetil
    6. Drug: sirolimus
    7. Drug: tacrolimus
    8. Procedure: allogeneic hematopoietic stem cell transplantation
    9. Procedure: peripheral blood stem cell transplantation
    label
    Regimen VI
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Regimen II
    2. Regimen VI
    name
    busulfan
    type
    DRUG
  2. arm Group Labels
    1. Regimen I
    2. Regimen II
    name
    cyclophosphamide
    type
    DRUG
  3. arm Group Labels
    1. Regimen I
    2. Regimen II
    3. Regimen III
    4. Regimen IV
    5. Regimen V
    6. Regimen VI
    name
    cyclosporine
    type
    DRUG
  4. arm Group Labels
    1. Regimen III
    name
    etoposide
    type
    DRUG
  5. arm Group Labels
    1. Regimen IV
    2. Regimen V
    3. Regimen VI
    name
    fludarabine phosphate
    type
    DRUG
  6. arm Group Labels
    1. Regimen IV
    name
    melphalan
    type
    DRUG
  7. arm Group Labels
    1. Regimen I
    2. Regimen II
    3. Regimen III
    4. Regimen IV
    5. Regimen V
    6. Regimen VI
    name
    methotrexate
    type
    DRUG
  8. arm Group Labels
    1. Regimen I
    2. Regimen II
    3. Regimen III
    4. Regimen IV
    5. Regimen V
    6. Regimen VI
    name
    mycophenolate mofetil
    type
    DRUG
  9. arm Group Labels
    1. Regimen I
    2. Regimen II
    3. Regimen III
    4. Regimen IV
    5. Regimen V
    6. Regimen VI
    name
    sirolimus
    type
    DRUG
  10. arm Group Labels
    1. Regimen I
    2. Regimen II
    3. Regimen III
    4. Regimen IV
    5. Regimen V
    6. Regimen VI
    name
    tacrolimus
    type
    DRUG
  11. arm Group Labels
    1. Regimen I
    2. Regimen II
    3. Regimen III
    4. Regimen IV
    5. Regimen V
    6. Regimen VI
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  12. arm Group Labels
    1. Regimen I
    2. Regimen II
    3. Regimen III
    4. Regimen IV
    5. Regimen V
    6. Regimen VI
    name
    peripheral blood stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
260
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is \> 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment.
    measure
    Neutrophil Engraftment - The Days Till ANC Recovery
    time Frame
    Up to 180 days post transplant
secondary Outcomes
  1. description
    Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 2 years after transplant and Kaplan-Meier survival analysis was used to generate the two-year Overall Survival estimate presented.
    measure
    Two-year Overall Survival
    time Frame
    Up to 2 years post transplant
Full study description
brief Summary
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.
detailed Description
OBJECTIVES: Primary * To evaluate hematopoietic recovery, using neutrophil and platelet engraftment as the primary criterion, in patients with advanced hematologic malignancies or other disorders undergoing allogeneic peripheral blood stem cell (PBSC) transplantation from matched unrelated donors. * To evaluate the incidence of acute and chronic graft-versus-host-disease (GVHD) in patients undergoing allogeneic PBSC transplantation from matched unrelated donors. Secondary * To evaluate the impact of HLA class I and class II allele-matching on the incidence of GVHD and on the survival outcome of these patients. * To evaluate overall survival, disease-free survival, and relapse in these patients. OUTLINE: Patients are stratified according to type of conditioning regimen (myeloablative vs reduced-intensity myeloablative). Patients are assigned to a conditioning regimen according to diagnosis, age, disease status, prior radiotherapy, and prior autologous stem cell transplantation. * Conditioning regimen: * Regimen I: Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. * Regimen II: Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. * Regimen III: Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. * Regimen IV: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. * Regimen V: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. * Regimen VI: Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. * Allogeneic peripheral blood stem cell (PBSC) transplantation: All patients undergo allogeneic PBSC transplantation on day 0. * Graft-versus-host disease (GVHD) prophylaxis: Patients receive one of the following GVHD prophylaxis regimens: * Regimen A: Patients receive tacrolimus IV or orally on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11. * Regimen B: Patients receive cyclosporine IV or orally twice daily on days -1 to 180, mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-27, and methotrexate IV on days 1, 3, and 6. * Regimen C: Patients receive tacrolimus IV continuously or orally, and oral sirolimus beginning on day -3. Patients also receive methotrexate IV on days 1, 3, and 6. After completion of study therapy, patients are followed periodically.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice