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CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib 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Brief Title

Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer

Official Title

A Multi-Center Study of Nonmyeloablative Conditioning With TBI or Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies With Post Grafting Immunosuppression With Tacrolimus and Mycophenolate Mofetil

Brief Summary

      This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing
      graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or
      without fludarabine phosphate followed by donor peripheral blood stem cell transplant for
      hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI
      before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.
      It also stops the patient's immune system from rejecting the donor's stem cells. The donated
      stem cells may replace the patient's immune system 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

      PRIMARY OBJECTIVES:

      I. To estimate the incidence of grade III/IV graft-versus-host disease (GVHD) after
      conditioning with 200 centigray (cGy) TBI alone or Fludarabine (fludarabine phosphate)/200
      cGy TBI followed by tacrolimus (Tac)/mycophenolate mofetil (MMF) immunosuppression in
      patients with hematologic malignancies.

      II. To estimate the incidence of chronic extensive GVHD.

      SECONDARY OBJECTIVES:

      I. To estimate the incidences of graft rejection.

      II. To estimate overall survival 1-year after conditioning.

      III. To evaluate the incidences of grades II-IV acute GVHD.

      IV. To evaluate the rates of disease progression and/or relapse-related mortality.

      V. To estimate the rate and duration of steroid use for the treatment of chronic GVHD.

      OUTLINE: Patients are assigned to 1 of 2 treatment arms.

      ARM I (nonmyeloablative conditioning with fludarabine phosphate and TBI): Patients receive
      fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0.

      ARM II (nonmyeloablative conditioning with TBI): Patients undergo TBI on day 0.

      All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and
      receive tacrolimus orally (PO) every 12 hours on days -3 to 180, with taper on day 56, or
      tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days
      0-27 or mycophenolate mofetil IV if unable to tolerate PO.

      Treatment continues in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 6 months for 2 years and
      then annually for 3 years.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Incidence of Grade III/IV GVHD

Secondary Outcome

 Incidences of Graft Rejection

Condition

Accelerated Phase Chronic Myelogenous Leukemia

Intervention

fludarabine phosphate

Study Arms / Comparison Groups

 Arm I (nonmyeloablative conditioning with fludarabine and TBI)
Description:  Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

150

Start Date

April 2004

Completion Date

July 2018

Primary Completion Date

March 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Patient must be not eligible for conventional allogeneic hematopoietic cell
             transplantation (HCT) and must have disease expected to be stable for at least 100
             days without chemotherapy; patients with hematologic malignancies treatable with HCT
             or with a B cell malignancy except those curable with autologous transplant will be
             included; patients not eligible for active disease specific protocols may be enrolled
             in this protocol; patients will include the following

          -  Diffuse large B cell non-Hodgkin lymphoma (NHL) and other aggressive lymphomas - not
             eligible for conventional myeloablative HCT or after autologous HCT

          -  Low grade NHL- with < 6 months duration of complete response (CR) between courses of
             conventional therapy

          -  Mantle cell NHL- may be treated in first CR

          -  Chronic lymphocytic leukemia (CLL) - must have either 1) failed to meet National
             Cancer Institute (NCI) Working Group criteria for complete or partial response after
             therapy with a regimen containing fludarabine phosphate (FLU) (or another nucleoside
             analog, e.g. 2-chlorodeoxyadenosine [2-CDA], pentostatin) or experience disease
             relapse within 12 months after completing therapy with a regimen containing FLU (or
             another nucleoside analog); 2) failed FLU-cyclophosphamide (CY)-Rituximab (FCR)
             combination chemotherapy at any time point; or 3) have "17p deletion" cytogenetic
             abnormality; patients should have received induction chemotherapy but could be
             transplanted in 1st CR; 4) patients with a diagnosis of CLL (or small lymphocytic
             lymphoma) or a diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or
             T-cell CLL or PLL

          -  Hodgkin lymphoma (HL) - must have received and failed frontline therapy; patients must
             have failed or were not eligible for autologous transplant

          -  Multiple myeloma (MM) - following a planned autologous transplant or equivalent
             high-dose therapy without a graft, or following a failed prior autograft

          -  Acute myeloid leukemia (AML) - must have < 5% marrow blasts at the time of transplant

          -  Acute lymphoblastic leukemia (ALL) - must have < 5% marrow blasts at the time of
             transplant

          -  Chronic myelogenous leukemia (CML) - patients will be accepted beyond first chronic
             phase (CP1) if they have received previous myelosuppressive chemotherapy or HCT, and
             have < 5% marrow blasts at time of transplant

          -  Myelodysplastic syndromes/myeloproliferative disorders (MDS/MPD) - must have received
             previous myelosuppressive chemotherapy or HCT, and have < 5% marrow blasts at time of
             transplant

          -  Waldenstrom's macroglobulinemia - must have failed 2 courses of therapy

          -  Myelosuppressive chemotherapy must be discontinued three weeks prior to conditioning
             with the exception of hydroxyurea or imatinib

          -  Patients < 12 years old must be approved by both the participating institutions'
             patient review committee such as the Patient Care Conference (PCC) at the Fred
             Hutchinson Cancer Research Center (FHCRC) and the FHCRC principal investigator

          -  Patient who refused to be treated on a conventional HCT protocol; for this inclusion
             criterion, transplants must be approved by both the participating institution's
             patient review committee such as the Patient Care Conference (PCC) at the FHCRC and
             the FHCRC principal investigators

          -  Patients with human leukocyte antigen (HLA)-matched related donors

          -  Patients with renal failure are eligible; however, patients with renal compromise
             (serum creatinine > 2.0) will likely have further compromise in renal function and may
             require hemodialysis (which may be permanent) due to the need to maintain adequate
             serum tacrolimus levels

          -  DONOR: Related donor who is HLA genotypically identical at least at one haplotype and
             may be phenotypically or genotypically identical at the allele level at HLA-A, -B, -C,
             -DRB1, and -DQB1

          -  DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis

          -  DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
             central venous catheter (femoral, subclavian)

        Exclusion Criteria:

          -  Eligible for a high priority curative autologous transplant

          -  Patient with rapidly progressive, aggressive NHL unless in minimal disease state

          -  Patients with chronic myelomonocytic leukemia (CMML)

          -  Life expectancy severely limited by diseases other than malignancy

          -  Any current central nervous system (CNS) involvement with disease refractory to
             intrathecal chemotherapy

          -  Presence of circulating leukemic blasts (in the peripheral blood) detected by standard
             pathology for patients with AML, ALL or CML

          -  Fertile men or women unwilling to use contraceptives during and for up to 12 months
             post treatment

          -  Female patients who are pregnant or breastfeeding

          -  Human immunodeficiency virus (HIV)-positive patients

          -  Patients with active non-hematologic malignancies (except non-melanoma skin cancers);
             this exclusion does not apply to patients with non-hematologic malignancies that do
             not require therapy

          -  Patients with a history of non-hematologic malignancies (except non-melanoma skin
             cancers) currently in a complete remission, who are less than 5 years from the time of
             complete remission, and have a > 20% risk of disease recurrence; this exclusion does
             not apply to patients with non-hematologic malignancies that do not require therapy

          -  Fungal pneumonia with radiological progression after receipt of amphotericin
             formulation or mold-active azoles for greater than 1 month

          -  Karnofsky score < 50 for adult patients

          -  Lansky-Play performance score < 50 for pediatric patients

          -  Symptomatic coronary artery disease or ejection fraction < 35% or other cardiac
             failure requiring therapy (or, if unable to obtain ejection fraction, shortening
             fraction of < 26%); ejection fraction is required if age > 50 years or there is a
             history of anthracycline exposure or history of cardiac disease; patients with a
             shortening fraction < 26% may be enrolled if approved by a cardiologist

          -  Poorly controlled hypertension

          -  Diffusing capacity of the lung for carbon monoxide (DLCO) < 30%, total lung capacity
             (TLC) < 30%, forced expiratory volume in one second (FEV1) < 30% and/or receiving
             supplementary continuous oxygen; the FHCRC principal investigator (PI) of the study
             must approve enrollment of all patients with pulmonary nodules

          -  Liver function abnormalities: Patients with clinical or laboratory evidence of liver
             disease would be evaluated for the cause of liver disease, its clinical severity in
             terms of liver function, and the degree of portal hypertension; patients will be
             excluded if they are found to have fulminant liver failure, cirrhosis of the liver
             with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis,
             esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy,
             uncorrectable hepatic synthetic dysfunction evinced 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, and
             symptomatic biliary disease

          -  Patients with active bacterial or fungal infections unresponsive to medical therapy

          -  DONOR: Age less than 12 years

          -  DONOR: Identical twin

          -  DONOR: Pregnancy

          -  DONOR: Infection with HIV

          -  DONOR: Known allergy to filgrastim (G-CSF)

          -  DONOR: Current serious systemic illness that would result in increased risk for G-CSF
             mobilization and harvest of peripheral blood stem cells (PBSC)
      

Gender

All

Ages

N/A - 74 Years

Accepts Healthy Volunteers

No

Contacts

David Maloney, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00089011

Organization ID

1898.00

Secondary IDs

NCI-2010-00267

Responsible Party

Sponsor

Study Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

David Maloney, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


Verification Date

December 2019