NCT01427881 · REGISTRY CONDITION SEARCH

Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies

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: 2017-05-19

This phase II trial studies how well cyclophosphamide works in preventing chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients with hematological malignancies. Giving chemotherapy and total-body irradiation before transplantation helps stop the growth of cancer cells and prevents the patient's immune system from rejecting the donor's stem cells. Healthy stem cells from a donor that are infused into the patient help the patient's bone marrow make blood cells; red blood cells, white blood cells, and platelets. Sometimes, however, the transplanted donor cells can cause an immune response against the body's normal cells, which is called graft-versus-host disease (GVHD). Giving cyclophosphamide after transplant may prevent this from happening or may make chronic GVHD less severe.

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

→

baseline

Baseline characteristics

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outcome · POSTED

Chronic GVHD Requiring Systemic Immunosuppressive Treatment

→

outcome · POSTED

Donor Engraftment

→

outcome · POSTED

Grades II-IV and III-IV Acute GVHD

→

outcome · POSTED

Duration of Systemic Immunosuppressive Treatment

→

outcome · POSTED

Persistent or Recurrent Malignancy After HCT

→

outcome · POSTED

Non-relapse Mortality

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outcome · POSTED

Overall Survival

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outcome · POSTED

Disease-free Survival

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outcome · POSTED

Hematologic Recovery

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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

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Acute lymphocytic leukemia (ALL) in morphologic first complete remission (CR1) with high risk features defined as, but not limited to: evidence of adverse cytogenetics such as t(9;22), t(1;19), t(4;11), or mixed-lineage leukemia (MLL) rearrangements; presence of minimal residual disease; progenitor B-cell immunophenotype; high white blood cells (WBC) at diagnosis (\> 30,000/ul in B-ALL; \> 100,000/ul in T-ALL); or delayed attainment of CR (\> 4 weeks) after induction therapy; additional clinical characteristics deemed to confer a high relapse risk may be discussed with and approved by the Principal Investigator (PI) * Acute myeloid leukemia (AML) in CR1 EXCEPT patients with low-risk features defined as: * Inv 16 or t(8;21) in the absence of c-kit mutations * Normal karyotype who are FLT3-ITD-negative and NPM1-positive in the absence of c-kit mutations * Patients with respective "low-risk" features are eligible, however, if (i) more than 1 cycle of induction therapy was required to achieve CR1 (ii) the patient had a preceding myelodysplastic syndrome (MDS) other than myelofibrosis, or (iii) secondary AML * Acute leukemia in 2nd or greater CR (CR \>= 2) * Refractory or relapsed AML with =\< 10% bone marrow blasts and no circulating blasts or proven extramedullary disease * AML transformed from myelodysplastic syndrome (MDS) with \< 10% bone marrow blasts * MDS with following high risk features: * High risk cytogenetics (including, but not limited to: 7q--, inv\[3\], t\[3q\], del\[3q\] or complex karyotype) * International Prognostic Scoring System (IPSS) intermediate (INT)-2 or greater * Treatment-related MDS * Any phase of MDS if patient is \< 21 years of age * Chronic myelogenous leukemia (CML) beyond 1st chronic phase or resistant or intolerant to tyrosine kinase inhibitors (adults) or any phase (pediatric \< 21 years) * Chronic myelomonocytic leukemia * Philadelphia-negative myeloproliferative disorder * Lymphoma: relapsed chemotherapy-sensitive (complete or partial response) Hodgkin or non-Hodgkin lymphoma * Multiple myeloma-stage III * The patient or legal representative must be able to understand and give written informed consent * DONORS: The donor must be a genotypically HLA-identical sibling, a phenotypically HLA-matched first-degree relative, or an unrelated donor who is molecularly matched with the patient at HLA-A, B, C, DRB1 * DONORS: Donors must meet the selection criteria for administration of G-CSF (filgrastim) and apheresis defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) * DONORS: Donors must be capable of giving informed consent Exclusion Criteria: * Prior autologous or allogeneic stem cell transplant * Performance status \> 2 (Eastern Cooperative Oncology Group \[ECOG\]) or \< 50 (Lansky; for patients \< 16 years old) * Uncontrolled infection; the protocol principal investigator (PI) will be final arbiter if there is uncertainty regarding whether a previous infection is under adequate control to allow enrollment in the study * Positive serology for human immunodeficiency virus (HIV)-1, 2 or human T cell lymphotropic virus (HTLV)-1, 2 * Left ventricular ejection fraction \< 45% or shortening fraction \< 25%; no uncontrolled arrhythmias or symptomatic cardiac disease * Symptomatic pulmonary disease; forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO) =\< 50% of predicted (corrected for hemoglobin); if pulmonary function tests cannot be performed, an oxygen saturation \< 92% on room air * Calculated (Cockcroft-Gault or appropriate calculation for pediatric patients) serum creatinine clearance =\< 60 mL/min; if the calculated CrCl is 50-60 mL/min, but a measured CrCl by 24 hour urine collection is \> 60 mL/min, this measurement is acceptable * Total serum bilirubin more than twice upper normal limit * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3-fold higher than laboratory upper normal limits * Female patient must have negative serum pregnancy test (all women of child bearing-potential must have test performed) * DONORS: Potential donors who for psychological, physiological, or medical reasons cannot tolerate administration of G-CSF or apheresis * DONORS: Donors who are allergic to filgrastim or Escherichia (E.) coli-derived proteins * DONORS: Donor-related risks to recipients * DONORS: Positive anti-donor lymphocytotoxic crossmatch * DONORS: Donors who are positive for HIV
healthy Volunteers: false
maximum Age: 65 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.
intervention Names
Drug: cyclophosphamide
Drug: cyclosporine
Procedure: peripheral blood stem cell transplantation
Radiation: total-body irradiation
Drug: fludarabine phosphate
Drug: busulfan
Procedure: allogeneic hematopoietic stem cell transplantation
label
Treatment (TBI, PBSCT, and cyclophosphamide GVHD prophylaxis)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (TBI, PBSCT, and cyclophosphamide GVHD prophylaxis)
description
Given IV
name
cyclophosphamide
other Names
CPM
CTX
Cytoxan
Endoxan
Endoxana
type
DRUG
arm Group Labels
Treatment (TBI, PBSCT, and cyclophosphamide GVHD prophylaxis)
description
Given IV
name
cyclosporine
other Names
ciclosporin
cyclosporin
cyclosporin A
CYSP
Sandimmune
type
DRUG
arm Group Labels
Treatment (TBI, PBSCT, and cyclophosphamide GVHD prophylaxis)
description
Undergo allogeneic PBSCT
name
peripheral blood stem cell transplantation
other Names
PBPC transplantation
PBSC transplantation
peripheral blood progenitor cell transplantation
transplantation, peripheral blood stem cell
type
PROCEDURE
arm Group Labels
Treatment (TBI, PBSCT, and cyclophosphamide GVHD prophylaxis)
description
Undergo TBI
name
total-body irradiation
other Names
TBI
type
RADIATION
arm Group Labels
Treatment (TBI, PBSCT, and cyclophosphamide GVHD prophylaxis)
description
Given IV
name
fludarabine phosphate
other Names
2-F-ara-AMP
Beneflur
Fludara
type
DRUG
arm Group Labels
Treatment (TBI, PBSCT, and cyclophosphamide GVHD prophylaxis)
description
Given IV
name
busulfan
other Names
BSF
BU
Misulfan
Mitosan
Myeloleukon
type
DRUG
arm Group Labels
Treatment (TBI, PBSCT, and cyclophosphamide GVHD prophylaxis)
description
Undergo allogeneic PBSCT
name
allogeneic hematopoietic stem cell transplantation
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 43
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from \~35% to \~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.
measure
Chronic GVHD Requiring Systemic Immunosuppressive Treatment
time Frame
At 1 year after transplantation

secondary Outcomes

description
Donor engraftment is defined as the count (percent) of patients with full donor chimerism. Full donor chimerism is defined as at least 95% donor CD3 cells in peripheral blood.
measure
Donor Engraftment
time Frame
At day 28
description
Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots.
measure
Grades II-IV and III-IV Acute GVHD
time Frame
Through day +100 post-transplant
description
The need for additional immunosuppressive treatment with agents other than those used for prophylaxis, the reasons for their administration (acute GVHD, chronic GVHD, or other reasons) and the duration of its administration will be determined. Patients will be monitored to determine the duration of systemic immunosuppressive treatment. Primary and secondary treatment of acute GVHD and withdrawal of systemic immunosuppressive treatment will be assessed with the use of cumulative incidence plots.
measure
Duration of Systemic Immunosuppressive Treatment
time Frame
Up to 5 years
description
Recurrent or progressive malignancy will be assessed with the use of cumulative incidence plots. Recurrent malignancy will be defined by hematologic criteria. Recurrent malignancy will also be defined as any unplanned medical intervention designed to prevent progression of malignant disease in patients who have molecular, cytogenetic or flow-cytometric evidence of malignant cells after transplantation.
measure
Persistent or Recurrent Malignancy After HCT
time Frame
At 2 years
description
Defined as death in the absence of recurrent or progressive malignancy after HCT. Non-relapse morality will be assessed with the use of cumulative incidence plots. This secondary endpoint will be characterized and presented as a cumulative incidence.
measure
Non-relapse Mortality
time Frame
At 2 years
description
Overall survival will be evaluated as Kaplan-Meier estimates.
measure
Overall Survival
time Frame
At 1 year post-transplant
description
Disease-free survival will be evaluated as Kaplan-Meier estimates.
measure
Disease-free Survival
time Frame
At 1 year post-transplant
description
Descriptive statistics will be used to assess the median days of neutrophil and platelet recovery. The day of neutrophil recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the absolute neutrophil count is \> 500/uL. The day of platelet recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the platelet count is \>= 20,000/uL without platelet transfusion support in the seven days prior.
measure
Hematologic Recovery
time Frame
Up to day +100
description
Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of \>= 500/uL by \>= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to \< 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors.
measure
Graft Failure
time Frame
By greater than or equal to 28 days post-transplant

Full study description

brief Summary: This phase II trial studies how well cyclophosphamide works in preventing chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients with hematological malignancies. Giving chemotherapy and total-body irradiation before transplantation helps stop the growth of cancer cells and prevents the patient's immune system from rejecting the donor's stem cells. Healthy stem cells from a donor that are infused into the patient help the patient's bone marrow make blood cells; red blood cells, white blood cells, and platelets. Sometimes, however, the transplanted donor cells can cause an immune response against the body's normal cells, which is called graft-versus-host disease (GVHD). Giving cyclophosphamide after transplant may prevent this from happening or may make chronic GVHD less severe.
detailed Description: PRIMARY OBJECTIVES: I. The primary objective of this study is to assess outcomes when high-dose cyclophosphamide (CY) is administered on days 3 and 4 followed by cyclosporine (CSP) after human leukocyte antigen (HLA)-matched related or unrelated mobilized blood cell transplantation with total-body irradiation (TBI) or busulfan (BU)-based conditioning. SECONDARY OBJECTIVES: I. The secondary objective of this study is to assess hematopoietic cell transplantation (HCT) outcomes when withdrawal of CSP is accelerated in patients without acute graft-versus-host disease (GVHD). OUTLINE: Patients' conditioning regimens are determined by the Clinical Coordinator after consultation with the attending physician. Based on disease, patients receive either TBI or fludarabine and busulfan. PREPARATIVE REGIMEN: Patients receive TBI twice daily (BID) on days -4 or -3 to -1. Some patients also receive fludarabine intravenously (IV) daily on days -5 to -2 and busulfan IV over 3 hours once daily (QD) or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo central nervous system (CNS) prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at day 180 and then annually for 5 years.

Source references

references

citation
Mielcarek M, Furlong T, O'Donnell PV, Storer BE, McCune JS, Storb R, Carpenter PA, Flowers ME, Appelbaum FR, Martin PJ. Posttransplantation cyclophosphamide for prevention of graft-versus-host disease after HLA-matched mobilized blood cell transplantation. Blood. 2016 Mar 17;127(11):1502-8. doi: 10.1182/blood-2015-10-672071. Epub 2016 Jan 13.
pmid
26764356
type
DERIVED

Source notices and limitations

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source kind
ctgov_condition_query
source record id
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source string basis
parsed_JSON_string_unmodified
source string sha256
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source url
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release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-9ee91108fce25be0a4a8
requested nct id
NCT01427881
primary nct id
NCT01427881
source kind
ctgov_condition_query
source url
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source record id
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source file sha256
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payload sha256
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payload
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end exclusive
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id
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link basis
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nct id
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occurrences
context exact
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query cond
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query disease state id
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source file
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source file sha256
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source json pointer
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source kind
ctgov_condition_query
source record id
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source string basis
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source string sha256
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source url
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release id
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edge id
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requested nct id
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primary nct id
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source kind
ctgov_condition_query
source url
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source record id
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source file sha256
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payload sha256
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payload
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end exclusive
true
id
nct-edge-cb8a951b07ad171a8525
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
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occurrences
context exact
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query cond
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query disease state id
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source file
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source file sha256
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source json pointer
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source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
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source url
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Preserved source evidence · Not medical advice