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NCT00003816 · REGISTRY CONDITION SEARCH

Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer

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

Phase
PHASE2, PHASE3
Status at capture
COMPLETED
Registry last update
2021-08-13

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.

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

CR Rate

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outcome · POSTED

Toxicity/TRM at Day 100

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outcome · POSTED

4 Year PFS

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outcome · POSTED

4 yr OS

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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: * 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 after first-line chemotherapy, including any of the following: * Chronic lymphocytic leukemia (CLL) (≥ 20% marrow involvement) * Waldenstrom macroglobulinemia * Low-grade non-Hodgkin lymphoma * Intermediate or high-grade non-Hodgkin lymphoma, meeting 1 of the following criteria: * Resistant or recurrent disease after combination chemotherapy with one standard regimen * Lymphoblastic lymphoma or small noncleaved cell lymphoma in first remission and at high risk of relapse * CNS disease * Bone marrow disease and LDH greater than 300 * Solid tumor that would otherwise be treated on RPCI-DS-9115 (or equivalent autologous stem transplant protocol) AND has a syngeneic donor * Autologous bone marrow transplant not possible (or desirable) due to 1 of the following: * History of marrow tumor * Inadequate marrow dose * Abnormal marrow histology or function prior to storage * Thrombocytopenia or leukopenia * Marrow cellularity \< 20% * Histocompatible donor identified * Well-matched donor, as defined by 1 of the following: * Family member matched for 5 or 6 HLA specificities (A, B, DR)\* * Unrelated donor meeting compatibility criteria of the National Marrow Donor Program (matched for HLA A, B, and DRB1 antigens)\* * Identical twin sibling * If a compatible cord blood donor is identified and there is no suitable unrelated donor available, patient may receive cord blood transplant NOTE: \*Patients ≤ 25 years of age may be singly mismatched at the A or B loci NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * 4 to 70 Performance status: * Zubrod 0-2 OR * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin \< 3 times normal (unless due to disease) * Alkaline phosphatase \< 3 times normal (unless due to disease) * SGOT \< 3 times normal (unless due to disease) * Hepatitis B surface antigen negative * No severe hepatic disease that would preclude study participation Renal: * Creatinine normal * Creatinine clearance ≥ 50 mL/min * No severe renal disease that would preclude study participation Cardiovascular: * Cardiac ventricular ejection fraction ≥ 50% by MUGA or echocardiogram * No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction, congestive heart failure, symptomatic angina, life threatening arrhythmia, or hypertension within the past 6 months) Pulmonary: * DLCO or DLVA ≥ 50% predicted (corrected for hemoglobin or alveolar ventilation) Other: * No serious concurrent medical or psychiatric illness * No other serious organ dysfunction (unless due to underlying disease), including the following: * Uncontrolled bacterial, viral, or fungal infection * Uncontrolled peptic ulcer disease * Uncontrolled diabetes mellitus * HIV negative * Cytomegalovirus status known * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * Pretransplant cytoreductive chemotherapy allowed for patients with relapsed or refractory disease Endocrine therapy: * Not specified Radiotherapy: * Not eligible for total-body irradiation if prior radiotherapy exceeded the following limits: * Mediastinum: 3,600 cGy * Heart: 3,600 cGy * Whole lungs: 1,200 cGy * Small bowel: 3,600 cGy * Kidneys: 1,200 cGy * Whole liver: 1,600 cGy * Cranial spinal: 3,600 cGy * Brain: 4,000 cGy * Retina: 4,000 cGy Surgery: * Not specified
healthy Volunteers
false
maximum Age
70 Years
minimum Age
4 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
    intervention Names
    1. Drug: busulfan
    2. Drug: cyclophosphamide
    label
    Regimen 1
    type
    EXPERIMENTAL
  2. description
    Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3.
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: cyclophosphamide
    label
    Regimen 2
    type
    EXPERIMENTAL
  3. description
    Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1.
    intervention Names
    1. Drug: cyclophosphamide
    2. Radiation: total-body irradiation
    label
    Regimen 3
    type
    EXPERIMENTAL
  4. description
    Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2.
    intervention Names
    1. Drug: fludarabine phosphate
    2. Drug: melphalan
    label
    Regimen 4
    type
    EXPERIMENTAL
  5. description
    Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.
    intervention Names
    1. Drug: cyclophosphamide
    2. Drug: etoposide
    3. Radiation: total-body irradiation
    label
    Regimen 5
    type
    EXPERIMENTAL
  6. description
    Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
    intervention Names
    1. Drug: carboplatin
    2. Drug: cyclophosphamide
    3. Drug: thiotepa
    label
    Regimen 6
    type
    EXPERIMENTAL
  7. description
    Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2.
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: fludarabine phosphate
    label
    Regimen 7
    type
    EXPERIMENTAL
  8. description
    Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: cyclophosphamide
    3. Radiation: total-body irradiation
    label
    Regimen 8
    type
    EXPERIMENTAL
  9. description
    Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: busulfan
    3. Drug: cyclophosphamide
    label
    Regimen 9
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Regimen 2
    2. Regimen 7
    3. Regimen 8
    4. Regimen 9
    description
    Given IV
    name
    anti-thymocyte globulin
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Regimen 1
    2. Regimen 9
    description
    Given IV
    name
    busulfan
    type
    DRUG
  3. arm Group Labels
    1. Regimen 6
    description
    Given IV
    name
    carboplatin
    type
    DRUG
  4. arm Group Labels
    1. Regimen 1
    2. Regimen 2
    3. Regimen 3
    4. Regimen 5
    5. Regimen 6
    6. Regimen 8
    7. Regimen 9
    description
    Given IV
    name
    cyclophosphamide
    type
    DRUG
  5. arm Group Labels
    1. Regimen 5
    description
    Given IV
    name
    etoposide
    type
    DRUG
  6. arm Group Labels
    1. Regimen 4
    2. Regimen 7
    description
    Given IV
    name
    fludarabine phosphate
    type
    DRUG
  7. arm Group Labels
    1. Regimen 4
    description
    Given IV
    name
    melphalan
    type
    DRUG
  8. arm Group Labels
    1. Regimen 6
    description
    Given IV
    name
    thiotepa
    type
    DRUG
  9. arm Group Labels
    1. Regimen 3
    2. Regimen 5
    3. Regimen 8
    description
    Given twice daily for 3 days
    name
    total-body irradiation
    type
    RADIATION
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
361
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Rate of Complete Remission by Day +100
    measure
    CR Rate
    time Frame
    day 100
secondary Outcomes
  1. description
    Death due to treatment related causes before day +100 after BMT
    measure
    Toxicity/TRM at Day 100
    time Frame
    Day +100
  2. description
    progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause)
    measure
    4 Year PFS
    time Frame
    4 years
  3. description
    Overall survival estimate at 4 years post BMT
    measure
    4 yr OS
    time Frame
    4-year
Full study description
brief 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.
detailed Description
OBJECTIVES: * Compare the morbidity, mortality, and overall outcome of patients with severe aplastic anemia or hematologic malignancy treated with standard vs novel conditioning regimens followed by allogeneic stem cell transplantation. * Examine the influence of donor histocompatibility on outcome by comparing matched/related, mismatched/related (with or without T-cell depletion), and matched/unrelated transplants with stratification for type of preparative regimen. * Ensure that patients with uncommon diagnoses will be treated in a uniform fashion with the best therapy available. OUTLINE: Patients are stratified according to risk of relapse (standard-risk: acute leukemia in first complete remission, chronic myelogenous leukemia in first chronic phase, lymphoma in sensitive first relapse or second remission, primary or untreated myelodysplastic syndromes, or untreated severe aplastic anemia vs high-risk: all others). Patients are assigned to one of the following conditioning regimens based on diagnosis, risk of relapse, and donor relatedness: * Regimen 1: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. * Regimen 2: Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -3. * Regimen 3: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and total-body irradiation (TBI) twice daily on days -3 to -1. * Regimen 4: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and melphalan IV over 1 hour on days -3 and -2. * Regimen 5: Patients receive etoposide IV over 26 hours beginning on day -5, cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1. * Regimen 6: Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4. * Regimen 7: Patients receive fludarabine IV over 30 minutes on days -5 to -1 and anti-thymocyte globulin IV over 4-8 hours on days -5 to -2. * Regimen 8: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3 to -1. * Regimen 9: Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. All patients then receive donor stem cell infusions on day 0. Some patients may undergo involved-field radiotherapy 4-8 weeks after transplant. Patients will be taken off study after a minimum of 4 years of follow up. PROJECTED ACCRUAL: At least 405 patients will be accrued for this study within 5 years.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice