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NCT00049504 · REGISTRY CONDITION SEARCH

Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk 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
Status at capture
COMPLETED
Registry last update
2017-05-17

This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them. Giving cyclophosphamide after transplant may also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening

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

Donor Engraftment (Chimerism)

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outcome · POSTED

Incidence of Grades III-IV Acute GVHD

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outcome · POSTED

Non-relapse-related Mortality

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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
Inclusion Criteria: * Chronic myeloid leukemia (CML) in accelerated phase (AP) * Acute myeloid leukemia (AML) with high-risk cytogenetics \[del(5q)/-5, del(7q)/-7, abnormal 3q, 9q, 11q, 20q, 21q, 17p, t(6:9), t(9;22), complex karyotypes (\>= 3 abnormalities)\] in complete remission (CR)1 * AML \>= CR2; patients should have \< 5% marrow blasts at the time of transplant * High-risk ALL defined as: CR1 with high-risk cytogenetics; t(9;22), t(4;11), or hypodiploid (\< 45 chromosomes) for pediatric patients; t(9;22), t(8;14), t(4;11), t(1;19) for adult patients; \> 4 wk to achieve CR1; \>= CR2 (patients should have \< 5% marrow blasts at the time of transplant) * Myelodysplastic syndromes (MDS) (\>int-1 per IPSS) after \>= 1 prior cycle of induction chemotherapy; should have \< 5% marrow blasts at the time of transplant * Multiple myeloma (MM) Stage II or III patients who have progressed after an initial response to chemotherapy or autologous hematopoietic stem cell transplantation (HSCT) or MM patients with refractory disease who may benefit from tandem autologous-nonmyeloablative allogeneic transplant * Chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD) who are ineligible for autologous HSCT or who have resistant/refractory disease and who may benefit from tandem autologous nonmyeloablative allogeneic transplant * Patients who have received a prior allogeneic HSCT and who have either rejected their grafts or who have become tolerant of their grafts with no active graft-versus-host disease (GvHD) requiring immunosuppressive therapy * DONOR: Related donors who are identical for one HLA haplotype and mismatched at the HLA-A, -B, -C or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or -C allele mismatches Exclusion Criteria: * Cross-match positive with donor * Patients with suitably matched related or unrelated donors * Patients with conventional transplant options (a conventional transplant should be the priority for eligible patients =\< 50 yr of age who have a related donor mismatched for a single HLA-A, -B or DRB1 antigen) * Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy * Presence of active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis, tuberculosis) * Karnofsky Performance Status \< 60 for adult patients * Lansky-Play Performance Score \< 60 for pediatric patients * Left ventricular ejection fraction \< 35% * Diffusing capacity of the lung for carbon monoxide (DLCO) \< 35% and/or receiving supplemental continuous oxygen * Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3 mg/dL or symptomatic biliary disease * Human immunodeficiency virus (HIV)-positive patients * Women of childbearing potential who are pregnant (beta-HCG+) or breast feeding * Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant * Life expectancy severely limited by diseases other than malignancy * DONOR: Donor-recipient pairs in which the HLA-mismatch is only in the HVG direction * DONOR: Cross-match positive with recipient
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1. TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35.
    intervention Names
    1. Drug: cyclophosphamide
    2. Drug: fludarabine phosphate
    3. Drug: tacrolimus
    4. Drug: mycophenolate mofetil
    5. Genetic: polymerase chain reaction
    6. Genetic: fluorescence in situ hybridization
    7. Genetic: polymorphism analysis
    8. Genetic: gene expression analysis
    9. Radiation: total-body irradiation
    10. Procedure: allogeneic bone marrow transplantation
    11. Procedure: allogeneic hematopoietic stem cell transplantation
    label
    Treatment (nonmyeloablative HSCT)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Given IV
    name
    cyclophosphamide
    other Names
    1. CPM
    2. CTX
    3. Cytoxan
    4. Endoxan
    5. Endoxana
    type
    DRUG
  2. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Given IV
    name
    fludarabine phosphate
    other Names
    1. 2-F-ara-AMP
    2. Beneflur
    3. Fludara
    type
    DRUG
  3. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Given IV or orally
    name
    tacrolimus
    other Names
    1. FK 506
    2. Prograf
    type
    DRUG
  4. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Given orally
    name
    mycophenolate mofetil
    other Names
    1. Cellcept
    2. MMF
    type
    DRUG
  5. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Correlative studies
    name
    polymerase chain reaction
    other Names
    1. PCR
    type
    GENETIC
  6. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Correlative studies
    name
    fluorescence in situ hybridization
    other Names
    1. fluorescence in situ hybridization (FISH)
    type
    GENETIC
  7. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Correlative studies
    name
    polymorphism analysis
    type
    GENETIC
  8. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Correlative studies
    name
    gene expression analysis
    type
    GENETIC
  9. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Undergo total-body irradiation
    name
    total-body irradiation
    other Names
    1. TBI
    type
    RADIATION
  10. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Undergo haploidentical hematopoietic bone marrow transplantation
    name
    allogeneic bone marrow transplantation
    other Names
    1. bone marrow therapy, allogeneic
    2. bone marrow therapy, allogenic
    3. transplantation, allogeneic bone marrow
    4. transplantation, allogenic bone marrow
    type
    PROCEDURE
  11. arm Group Labels
    1. Treatment (nonmyeloablative HSCT)
    description
    Undergo haploidentical hematopoietic bone marrow transplantation
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
53
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population
    measure
    Donor Engraftment (Chimerism)
    time Frame
    At day +84 after transplantation
  2. description
    Grade III GVHD represents moderate severity. Grade IV GVHD represents extreme severity
    measure
    Incidence of Grades III-IV Acute GVHD
    time Frame
    At any time within 200 days after transplantation
  3. description
    Number of deaths without progression or recurrence of malignant disease
    measure
    Non-relapse-related Mortality
    time Frame
    Up to 200 days after transplantation
Full study description
brief Summary
This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them. Giving cyclophosphamide after transplant may also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening
detailed Description
OBJECTIVES: I. To determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative bone marrow transplantation (BMT) from human leukocyte antigen (HLA)-haploidentical donors. OUTLINE: NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1. TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus orally (PO), once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 months and then annually thereafter.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice