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    • David Wallace BioDavid Wallace - MPN Patient Advocate

      David Wallace

      Founder & CEO of MPN Cancer Connection and PV Reporter | Patient Advocate

      When David was diagnosed with PV in 2009, at the age of 47, he soon learned there was limited and often conflicting information available on Myeloproliferative Neoplasms (MPNs). He also realized early on in his diagnosis, the importance of advocating for himself to best manage his polycythemia vera (PV). David was grateful for the early support and guidance of fellow MPN patients on his journey and wanted a way to give back to the MPN community. With a professional background in business administration and sociology, David has a passion for finding solutions and helping others. In 2013, David used his skill set to create PV Reporter,
      a comprehensive patient-focused website for MPNs. David refers to his site as a hub for patients to begin to research their cancer. Whether a patient, caregiver or healthcare provider, PV Reporter offers visitors a wealth of educational resources, patient stories, articles, and the latest news on the treatment for MPNs, helping MPN patients and their caregivers stay informed, connected and empowered. In 2015, along with the help of others, David founded a non-profit MPN Cancer Connection (MPN-CC), a patient-led 501©3 formed to create awareness that MPN patients are “cancer patients” and should have complete access to local and national programs and benefits. David’s philosophy is to educate patients to become their own advocates so that they can make informed decisions on their treatment. David’s dedication to the MPN community is further evidenced through his work and awards:
      • Selected to endorse 2018 NCCN guidelines for MPN patients by MPN Cancer Connection
      • Selected to represent the United States as a patient advocate by MPNs Advocate Network International Conference 2016-2019
      • Recipient of MPN Hero Award 2016
      • Published in MD Anderson Cancer Center MPN Focus Newsletter Fall 2016
      • Appearance on “The Doctors” TV show in 2015 to promote MPN awareness
      • Awarded Press Credentials for American Society of Hematology Conference 2014-2019
      • Contributor to Patient Power MPN educational videos
      David lives in Charlotte, North Carolina. When he’s not working, David enjoys spending time with family, listening to live music, attending outdoor festivals, watching the Carolina Panthers, riding his motorcycle, traveling and of course having his beloved Aussiedoodle Bailey by his side.
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Clinical Trial Finder

Clinical Trial Finder

Search Results

Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01028716
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fred Hutchinson Cancer Research Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rachel B. Salit
Principal Investigator Affiliation Fred Hutch/University of Washington Cancer Consortium
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Biphenotypic Leukemia, Acute Erythroid Leukemia in Remission, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia in Remission, Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM, Acute Myeloid Leukemia With Multilineage Dysplasia, Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214, Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Complete Remission, B Acute Lymphoblastic Leukemia With t(1;19)(q23;p13.3); E2A-PBX1 (TCF3-PBX1), B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Burkitt Lymphoma, Childhood Acute Lymphoblastic Leukemia in Complete Remission, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma, Myelodysplastic Syndrome, Recurrent Anaplastic Large Cell Lymphoma, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Recurrent Follicular Lymphoma, Recurrent Hodgkin Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma, Secondary Acute Myeloid Leukemia, T Lymphoblastic Lymphoma, Hematopoietic Cell Transplant Recipient
Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment (nonmyeloablative HCT, TBI)

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.

Interventions

Drug: - Cyclophosphamide

Given IV

Biological: - Filgrastim

Given IV

Drug: - Fludarabine Phosphate

Given IV

Procedure: - Laboratory Biomarker Analysis

Correlative studies

Drug: - Mycophenolate Mofetil

Given PO

Procedure: - Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Undergo PBSC

Procedure: - Peripheral Blood Stem Cell Transplantation

Undergo PBSC

Drug: - Tacrolimus

Given IV or PO

Radiation: - Total-Body Irradiation

Undergo total-body irradiation (TBI)

Drug: - Fludarabine

Given IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

VA Puget Sound Health Care System, Seattle, Washington

Status

Withdrawn

Address

VA Puget Sound Health Care System

Seattle, Washington, 98101

Site Contact

rsalit@fredhutch.org

206-667-1317

Seattle, Washington

Status

Recruiting

Address

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

Site Contact

Rachel B. Salit

rsalit@fredhutch.org

206-667-1317

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