NCT01028716 · REGISTRY CONDITION SEARCH

Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic 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: TERMINATED
Registry last update: 2023-01-23

This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (fludarabine phosphate and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in treating the patient's disease than using bone marrow.

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

Non-relapse Mortality at 1 Year

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outcome · POSTED

Percentage of Participants With Chronic Graft Versus Host Disease

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outcome · POSTED

Incidence of Grades III/IV Acute Graft Versus Host Disease

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outcome · POSTED

Relapse of Malignancy After Transplantation

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outcome · POSTED

Time to Neutrophil Recovery

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outcome · POSTED

Time to Platelet Recovery

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outcome · POSTED

Incidence of Primary Graft Failure

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outcome · POSTED

Disease-free Survival

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outcome · POSTED

Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System

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outcome · POSTED

Number of Red Blood Cell Transfusions

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outcome · POSTED

Number of Platelet Transfusions

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outcome · POSTED

Point Estimate of Overall Survival at 3 Years

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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: * Molecular based human leukocyte antigen (HLA) typing will be performed for the HLA-A, -B, -Cw, -DRB1 and -DQB1 loci to the resolution adequate to establish haplo-identity; a minimum match of 5/10 is required; an unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant; clinical urgency is defined as 6-8 weeks from referral or low-likelihood of finding a matched, unrelated donor * Acute leukemias (includes T lymphoblastic lymphoma); remission is defined as \< 5% blasts with no morphological characteristics of acute leukemia (e.g., Auer rods) in a bone marrow with \> 20% cellularity, peripheral blood counts showing ANC \> 1000/ul, including patients in complete remission with incomplete platelet recovery (CRp); if the marrow has \< 20% cellularity due to treatment related cytotoxicity, but still has \< 5% blasts, an exception may be made to include this patient up to principal investigator (PI) discretion * Acute lymphoblastic leukemia in high risk first complete remission (CR1) as defined by at least one of the following: * Adverse cytogenetics including but not limited to t(9;22), t(1;19), t(4;11), mixed lineage leukemia (MLL) rearrangements * White blood cell counts \> 30,000/mcL * Patients over 30 years of age * Time to complete remission \> 4 weeks * Presence of extramedullary disease * Minimal residual disease * Other risk factors determined by the patient's attending physician to be high risk features requiring transplantation * Acute myelogenous leukemia in high risk CR1 as defined by at least one of the following: * Greater than 1 cycle of induction therapy required to achieve remission * Preceding myelodysplastic syndrome (MDS) * Presence of fms-like tyrosine kinase receptor-3 (Flt3) abnormalities * French-American-British (FAB) M6 or M7 leukemia, or * Adverse cytogenetics for overall survival such as: * Those associated with MDS * Complex karyotype (\>= 3 abnormalities); or * Any of the following: inv(3) or t(3;3), t(6;9), t(6;11), + 8 \[alone or with other abnormalities except for t(8;21), t(9;11), inv(16) or t(16;16)\], t(11;19)(q23;p13.1)\] * Other risk factors determined by the patient's attending physician to be high risk features requiring transplantation * Acute leukemias in second (2nd) or subsequent remission * Biphenotypic/undifferentiated leukemias in first (1st) or subsequent complete remission (CR) * High-risk MDS status-post cytotoxic chemotherapy * Burkitt's lymphoma: second or subsequent CR * Chemotherapy-sensitive (at least stable disease) large cell, mantle cell or Hodgkin's lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are ineligible for an autologous transplant * Marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least two prior therapies (excluding single agent Rituxan) * 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 * Left ventricular ejection fraction at rest must be \>= 35% * Bilirubin =\< 2.5 mg/dL * Alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) \< 5 x ULN * Alkaline phosphatase \< 5 x ULN * Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or glomerular filtration rate \[GFR\]) \> 40 mL/min/1.73m\^2 * Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), diffusion capacity of carbon monoxide (DLCO) (diffusion capacity) \>= 40% predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then oxygen (O2) saturation \> 92% on room air * Karnofsky/Lansky score \>= 60% * 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 GVHD requiring immunosuppressive therapy * Patients will undergo standard pre-transplant work-up as dictated by standard practice guidelines the results of which may be used for screening for this study * DONOR: Donors must be HLA-haploidentical first-degree relatives of the patient; eligible donors include biological parents, siblings, or children, or half-siblings * DONOR: Age \>= 12 years * DONOR: Weight \>= 40 kg * DONOR: Ability of donors \< 18 years of age to undergo apheresis without use of a vascular access device; vein check must be performed and verified by an apheresis nurse prior to arrival at the Seattle Cancer Care Alliance (SCCA) * DONOR: Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines Exclusion Criteria: * HLA-matched or single allele-mismatched donor able to donate * Pregnancy or breast-feeding * Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings) * Patients with primary idiopathic myelofibrosis * DONOR: Positive anti-donor HLA antibody
healthy Volunteers: false
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Patients undergo donor peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
intervention Names
Drug: Cyclophosphamide
Biological: Filgrastim
Drug: Fludarabine Phosphate
Drug: Mycophenolate Mofetil
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Drug: Tacrolimus
Radiation: Total-Body Irradiation
label
Treatment (nonmyeloablative HCT, TBI)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (nonmyeloablative HCT, TBI)
description
Given IV
name
Cyclophosphamide
other Names
(-)-Cyclophosphamide
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
Carloxan
Ciclofosfamida
Ciclofosfamide
Cicloxal
Clafen
Claphene
CP monohydrate
CTX
CYCLO-cell
Cycloblastin
type
DRUG
arm Group Labels
Treatment (nonmyeloablative HCT, TBI)
description
Given SQ
name
Filgrastim
other Names
Filgrastim XM02
Filgrastim-sndz
G-CSF
Neupogen
r-metHuG-CSF
Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
rG-CSF
Tbo-filgrastim
Tevagrastim
Zarxio
type
BIOLOGICAL
arm Group Labels
Treatment (nonmyeloablative HCT, TBI)
description
Given IV
name
Fludarabine Phosphate
other Names
2-F-ara-AMP
9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-
Beneflur
Fludara
SH T 586
type
DRUG
arm Group Labels
Treatment (nonmyeloablative HCT, TBI)
description
Given PO
name
Mycophenolate Mofetil
other Names
Cellcept
MMF
type
DRUG
arm Group Labels
Treatment (nonmyeloablative HCT, TBI)
description
Undergo PBSC
name
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
other Names
Non-myeloablative allogeneic transplant
Nonmyeloablative Stem Cell Transplantation
NST
type
PROCEDURE
arm Group Labels
Treatment (nonmyeloablative HCT, TBI)
description
Undergo PBSC
name
Peripheral Blood Stem Cell Transplantation
other Names
PBPC transplantation
Peripheral Blood Progenitor Cell Transplantation
Peripheral Stem Cell Support
Peripheral Stem Cell Transplant
Peripheral Stem Cell Transplantation
type
PROCEDURE
arm Group Labels
Treatment (nonmyeloablative HCT, TBI)
description
Given IV or PO
name
Tacrolimus
other Names
FK 506
Fujimycin
Hecoria
Prograf
Protopic
type
DRUG
arm Group Labels
Treatment (nonmyeloablative HCT, TBI)
description
Undergo total-body irradiation (TBI)
name
Total-Body Irradiation
other Names
TOTAL BODY IRRADIATION
Whole-Body Irradiation
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 46
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Cumulative incidence of death without evidence of disease progression at 1 year
measure
Non-relapse Mortality at 1 Year
time Frame
Up to 1 year
description
Scored according to the National Cancer Institute criteria. Mild-to-severe chronic GVHD at 2 years.
measure
Percentage of Participants With Chronic Graft Versus Host Disease
time Frame
Up to 2 years post-transplant
description
Grading determined by organ system stages. Grade III/IV acute graft versus host disease is defined as skin: stage IV, liver: stages II-IV, and/or gastrointestinal tract: stages II-IV.
measure
Incidence of Grades III/IV Acute Graft Versus Host Disease
time Frame
At day 84
description
Defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of lymphoma progression. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy.
measure
Relapse of Malignancy After Transplantation
time Frame
Up to 7 years

secondary Outcomes

description
Achievement of an absolute neutrophil count greater or equal to 500/mm\^3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil recovery.
measure
Time to Neutrophil Recovery
time Frame
Up to day 84 post-transplant
description
The first day of a sustained platelet count \> 20,000/mm\^3 with no platelet transfusions in the preceding seven days.
measure
Time to Platelet Recovery
time Frame
Up to day 84 post-transplant
description
Defined as \< 5% donor CD3 chimerism. Chimerism will be measured by short tandem repeat-polymerase chain reaction on peripheral blood sorted into CD3 and CD33 cell fractions.
measure
Incidence of Primary Graft Failure
time Frame
At day 84
description
Defined as being alive and in remission by \< 5% blasts by bone marrow morphology for patients with myeloid malignancies and CT or PET imaging for patients with lymphoid malignancies at the time of the assessment
measure
Disease-free Survival
time Frame
3 years from the date of transplant
description
Assessed by Common Terminology Criteria for Adverse Events version 3.0. The incidence of all adverse events greater or equal to grade 3 was determined.
measure
Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System
time Frame
Up to day 90
description
Number of units of RBCs given to the patient between day 0 and day 100 post transplant
measure
Number of Red Blood Cell Transfusions
time Frame
Day 0-100
description
Number platelet transfusions given to the patient between day 0 and day 100 post transplant
measure
Number of Platelet Transfusions
time Frame
Day 0-100
description
Kaplan Meier estimate of the percentage of participants with overall survival at 3 years
measure
Point Estimate of Overall Survival at 3 Years
time Frame
3 years

Full study description

brief Summary: This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (fludarabine phosphate and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in treating the patient's disease than using bone marrow.
detailed Description: PRIMARY OBJECTIVES: I. To demonstrate that use of PBSC in place of marrow as the source of lymphocytes and stem cells for nonmyeloablative transplants from related, haploidentical donors will not result in unacceptable rates of high-grade acute or chronic GVHD, non-relapse mortality or relapse compared to historical data on nonmyeloablative transplants from unrelated donors. SECONDARY OBJECTIVES: I. Estimates of the rates of neutrophil and platelet recovery, number of red blood cell (RBC) and platelet transfusions, incidences of graft failure, transplant-related toxicities, disease-free survival and overall survival. OUTLINE: Patients receive fludarabine intravenously (IV) over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Patients undergo donor peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV once daily or orally (PO) twice daily (BID) on days 5-180 (may be continued if active GVHD is present), mycophenolate mofetil IV or PO thrice daily (TID) on days 5-35 (may be continued if GVHD present), and filgrastim IV beginning on day 5 until the absolute neutrophil count (ANC) is \>= 1,000/mm\^3 for three consecutive days. Treatment continues in the absence of disease progression or unacceptable toxicity.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice