NCT00555048 · REGISTRY CONDITION SEARCH

Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With 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: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2017-05-24

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer 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 and methotrexate after the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with hematologic cancer.

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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

Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality

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outcome · POSTED

Life-threatening Infection

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outcome · POSTED

Grades III-IV Acute Graft-vs-host Disease (GVHD)

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outcome · POSTED

Overall Survival

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outcome · POSTED

Disease Relapse

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outcome · POSTED

Extensive Chronic GVHD

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outcome · POSTED

Graft Failure

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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: * Confirmed diagnosis of one of the following: * Primary acute myeloid leukemia (AML) meeting any of the following criteria: * First complete remission (CR; defined as \< 5% blasts in marrow) with high-risk features as defined by failure to achieve remission by day 21 after induction chemotherapy, or the presence of chromosomal abnormalities involving any of the following: * -5/del(5q) * -7/del(7q) * Inversion 3q * Abnormalities of 11q23, 20q, 21q, del(9q), * Translocation 6;9 * Translocation 9;22 * Abnormalities of 17p * Complex karyotype with ≥ 3 abnormalities * Second CR or subsequent in remission * Refractory or relapsed disease * Secondary AML in remission or relapse * Chronic myelogenous leukemia (CML) in accelerated or blast phase meeting the following criteria: * Accelerated phase is defined by any one of the following: * Blasts 10% to 19% of peripheral blood white cells or bone marrow cells * Peripheral blood basophils ≥ 20% * Persistent thrombocytopenia (\< 100,000/mm³) unrelated to therapy, or persistent thrombocytosis (\> 1,000,000/mm³) unresponsive to therapy * Increasing spleen size and increasing WBC count unresponsive to therapy * Cytogenetic evidence of clonal evolution (i.e., the appearance of an additional genetic abnormality that was not present in the initial specimen at the time of diagnosis of chronic phase CML) * Blast phase is defined by any of the following: * Blasts ≥ 20% of peripheral blood white cells or bone marrow cells * Extramedullary blast proliferation * Large foci or clusters of blasts in bone marrow biopsy * Primary myelodysplastic syndromes (MDS) with an IPSS score \> 1.5 * Secondary MDS with any IPSS score * Primary acute lymphoblastic leukemia meeting any of the following criteria: * First CR (\< 5% blasts in marrow) with high-risk features as defined by 1 of the following: * Failure to achieve remission after first induction chemotherapy * Presence of chromosomal abnormalities including hypodiploidy or abnormalities of 11q23 or translocation 9;22 * Second CR or subsequent in remission * Refractory or relapsed disease * No patients for whom a suitable HLA genotypically identical sibling or fully matched HLA-A, -B, -C, and -DRB1 unrelated donor is available * No active CNS involvement with disease * Donors must meet the following criteria: * Unrelated volunteer donors who are mismatched for more than one HLA-class I alleles or antigens or for one HLA-class I antigen, but matched by high-resolution typing at HLA-DRB1 and -DQB1, OR who are mismatched for one or more HLA-class II alleles or antigens, but matched by high-resolution typing at HLA-A, -B, and -C * No two-antigen mismatch at a single HLA-A, -B, or -C locus * No mismatching of class I and class II HLA * Matching must be based on results of high-resolution typing at HLA-A, -B, -C, - DRB1, and -DQB1 PATIENT CHARACTERISTICS: * Karnofsky performance status 50-100% * No symptomatic coronary artery disease or symptomatic congestive heart failure * No hepatic disease with transaminases or bilirubin \> 2 times upper limit of normal except for isolated hyperbilirubinemia attributed to Gilbert's syndrome * No severe hypoxemia with room air P\_AO\_2 \< 70, supplemental oxygen-dependence, or DLCO \< 60% predicted * No impaired renal function with creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% normal * Not HIV seropositive * Not pregnant or breast-feeding * Fertile patients must use effective contraception * No active infections that are untreated or failing to respond to appropriate therapy PRIOR CONCURRENT THERAPY: Inclusion criteria: * See Disease Characteristics Exclusion criteria: * Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation using a high-dose total-body irradiation regimen
healthy Volunteers: false
maximum Age: 50 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
intervention Names
Biological: alemtuzumab
Drug: busulfan
Drug: cyclophosphamide
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
label
Alemtuzumab
type
EXPERIMENTAL

interventions

arm Group Labels
Alemtuzumab
name
alemtuzumab
type
BIOLOGICAL
arm Group Labels
Alemtuzumab
name
busulfan
type
DRUG
arm Group Labels
Alemtuzumab
name
cyclophosphamide
type
DRUG
arm Group Labels
Alemtuzumab
name
methotrexate
type
DRUG
arm Group Labels
Alemtuzumab
name
tacrolimus
type
DRUG
arm Group Labels
Alemtuzumab
name
allogeneic hematopoietic stem cell transplantation
type
PROCEDURE
arm Group Labels
Alemtuzumab
name
peripheral blood stem cell transplantation
type
PROCEDURE

Study design

primary Purpose: TREATMENT

Enrollment

count: 1
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Lowest dose of alemtuzumab associated with transplant-related mortality at day 180
measure
Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality
time Frame
Up to day 180

secondary Outcomes

measure
Life-threatening Infection
time Frame
Up to 180 days
measure
Grades III-IV Acute Graft-vs-host Disease (GVHD)
time Frame
Up to 100 days
description
Count of surviving participants at 1 year
measure
Overall Survival
time Frame
Up to 1 year
description
Count of participants with disease relapse at 1 year
measure
Disease Relapse
time Frame
Up to 1 year
description
Count of participants with extensive chronic GVHD at 1 year
measure
Extensive Chronic GVHD
time Frame
Up to 1 year
description
Count of participants with graft failure at day 100
measure
Graft Failure
time Frame
Up to day 100

Full study description

brief Summary: RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer 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 and methotrexate after the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with hematologic cancer.
detailed Description: OBJECTIVES: Primary * Identify the lowest dose of alemtuzumab that is associated with day 180 transplant-related mortality ≤ 45%. Secondary * Determine the incidence of life-threatening infection in patients receiving this treatment. * Determine the incidence of grades III-IV acute graft-vs-host disease (GVHD) in patients receiving this treatment. * Determine the survival at 1 year in patients receiving this treatment. * Determine the incidence of disease relapse at 1 year in patients receiving this treatment. * Determine the incidence of extensive chronic GVHD at 1 year in patients receiving this treatment. * Determine the incidence of graft failure at day 100 in patients receiving this treatment. OUTLINE: * Chemotherapy: Patients receive alemtuzumab IV over 2 hours on days -10 to -6, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV on days -3 and -2. * Peripheral blood stem cell (PBSC) transplantation: Patients undergo allogeneic filgrastim (G-CSF)-mobilized PBSC transplantation on day 0. * Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 50 and methotrexate IV on days 1, 3, 6, and 11. After completion of study therapy, patients are followed periodically.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice