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NCT01118013 · REGISTRY CONDITION SEARCH

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

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
TERMINATED
Registry last update
2017-03-24

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 .

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

Event-free Survival (EFS)

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outcome · POSTED

Comparison of EFS Distribution to That of CALGB-100002

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outcome · POSTED

Complete Response Rate

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outcome · POSTED

Overall Survival

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outcome · POSTED

Rate of Opportunistic Infections

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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: * 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 typing for class II (DRB1) required * 8/8 matched-unrelated donor * Molecular identity at HLA A, B, C, and DRB1 by high-resolution typing required * No syngeneic donors PATIENT CHARACTERISTICS: * Creatinine clearance ≥ 40 mL/min * Total bilirubin ≤ 2 mg/dL * AST ≤ 3 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * DLCO ≥ 40% with no symptomatic pulmonary disease * LVEF ≥ 30% by MUGA or ECHO * No uncontrolled diabetes mellitus or active serious infection * No known hypersensitivity to E.coli-derived products * No HIV infection PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks should elapse between prior standard cytotoxic chemotherapy, radiation therapy, or surgery and the planned start of the preparative regimen on day -7
healthy Volunteers
false
maximum Age
69 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60. Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover. Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks. Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years.
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Biological: donor lymphocytes
    3. Biological: filgrastim
    4. Biological: therapeutic allogeneic lymphocytes
    5. Drug: busulfan
    6. Drug: fludarabine phosphate
    7. Drug: methotrexate
    8. Drug: mycophenolate mofetil
    9. Drug: tacrolimus
    10. Other: reduced-intensity transplant conditioning procedure
    11. Procedure: allogeneic hematopoietic stem cell transplantation
    12. Procedure: peripheral blood stem cell transplantation
    label
    Treatment
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment
    name
    anti-thymocyte globulin
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Treatment
    name
    donor lymphocytes
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Treatment
    name
    filgrastim
    type
    BIOLOGICAL
  4. arm Group Labels
    1. Treatment
    name
    therapeutic allogeneic lymphocytes
    type
    BIOLOGICAL
  5. arm Group Labels
    1. Treatment
    name
    busulfan
    type
    DRUG
  6. arm Group Labels
    1. Treatment
    name
    fludarabine phosphate
    type
    DRUG
  7. arm Group Labels
    1. Treatment
    name
    methotrexate
    type
    DRUG
  8. arm Group Labels
    1. Treatment
    name
    mycophenolate mofetil
    type
    DRUG
  9. arm Group Labels
    1. Treatment
    name
    tacrolimus
    type
    DRUG
  10. arm Group Labels
    1. Treatment
    name
    reduced-intensity transplant conditioning procedure
    type
    OTHER
  11. arm Group Labels
    1. Treatment
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  12. arm Group Labels
    1. Treatment
    name
    peripheral blood stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
6
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method.
    measure
    Event-free Survival (EFS)
    time Frame
    Duration of study (up to 5.5 years)
  2. description
    EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.
    measure
    Comparison of EFS Distribution to That of CALGB-100002
    time Frame
    2 years
secondary Outcomes
  1. description
    Complete response (CR) rate is reported as the percentage of participants who achieved a CR.
    measure
    Complete Response Rate
    time Frame
    Up to 5.5 years
  2. description
    Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
    measure
    Overall Survival
    time Frame
    Up to 5.5 years
  3. description
    Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant.
    measure
    Rate of Opportunistic Infections
    time Frame
    1 year post transplant
Full study description
brief 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 .
detailed Description
OBJECTIVES: Primary * To demonstrate the efficacy of performing reduced-intensity conditioning allogeneic hematopoietic cell transplantation in patients with relapsed hematologic malignancies or secondary myelodysplasia after completion of prior high-dose chemotherapy and autologous hematopoietic stem cell transplantation. * To compare the strategy of this regimen with the strategy used in CALGB-100002. Secondary * To describe the response rate at 6 and 12 months in patients treated with this regimen. * To describe the time-to-progression in patients treated with this regimen. * To determine the ability to use pharmacokinetic-directed busulfan to achieve AUC within 20% of target AUC in \> 80% of patients. * To determine percent of donor chimerism in T-cell, myeloid and B-cell populations achieved with this regimen compared with CALGB-100002. * To determine the risk of acute and chronic graft-versus-host disease and other toxicities of this regimen in these patients. * To describe the overall survival and disease-free survival of patients treated on this regimen. * To determine the rate of viral, bacterial, and fungal opportunistic infections occurring in the first year after transplantation compared with CALGB-100002. OUTLINE: This is a multicenter study. * Preparative Regimen: * Busulfan test dose: Patients receive busulfan IV over 45 minutes once during days -14 and -9. * Busulfan treatment dose: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and busulfan IV over 3 hours on days -6 to -3. * Graft-vs-Host Disease (GVHD) Prophylaxis: * HLA-identical donor: Patients receive antithymocyte globulin IV over 6-10 hours on days -6 to -5; oral tacrolimus twice daily on days -2 to 90 followed by a taper\* as tolerated until day 150 or 180; and methotrexate IV on days 1, 3, and 6. NOTE: \* Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3+ cells is \< 50% at day 60 or patient has progressive disease. * Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60. * Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover. * Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks. Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice