Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders

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Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated 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 In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders

Official Title

A Pilot Trial Of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan, And Low Dose Total Body Irradiation

Brief Summary

      This clinical trial is studying how well giving fludarabine phosphate and melphalan together
      with total-body irradiation followed by donor stem cell transplant works in treating patients
      with hematologic cancer or bone marrow failure disorders. Giving low doses of chemotherapy
      and total-body irradiation before a donor peripheral blood stem cell transplant helps stop
      the growth of cancer cells or abnormal cells. It may also stop the patient's immune system
      from rejecting the donor's stem cells. The donated stem cells may replace the patient's
      immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor
      effect)
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the transplant related mortality (TRM) of this reduced intensity
      transplantation (RIT) combination in a patient population that is usually not eligible for a
      full myeloablative allogeneic transplant.

      SECONDARY OBJECTIVES:

      I. To evaluate engraftment, safety, clinical response, evidence of graft-versus-malignancy
      effect/graft-versus-host disease (GVHD) and overall outcomes of treatment with our RIT
      regimen across a variety of hematological conditions.

      OUTLINE: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5
      to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body
      irradiation on day -1 and allogeneic stem cell transplantation on day 0.

      Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis
      congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of
      melphalan.

      After completion of study treatment, patients are followed up periodically.
    


Study Type

Interventional


Primary Outcome

Day 100 TRM

Secondary Outcome

 Median Time to ANC Engraftment

Condition

Accelerated Phase Chronic Myelogenous Leukemia

Intervention

fludarabine phosphate

Study Arms / Comparison Groups

 Treatment (Reduced intensity allogeneic stem cell transplant)
Description:  Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.

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

62

Start Date

January 14, 2009

Completion Date

March 13, 2019

Primary Completion Date

August 9, 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of a histology documented hematologic malignancy or marrow disorder

          -  Bone marrow failure disorders and other non-malignant hematologic or immunologic
             disorders:

               -  Acquired bone marrow failure disorders include aplastic anemia, paroxysmal
                  nocturnal hemoglobinuria (PNH):

                    -  Primary allogeneic hematopoietic stem cell transplantation (HSCT) is
                       appropriate for selected patients with severe aplastic anemia; however,
                       patients with aplastic anemia must have failed at least one cycle of
                       standard immunosuppressive therapy with calcineurin inhibitor plus
                       anti-thymocyte globulin (ATG) if a fully-matched donor is not available

                    -  Patients with PNH must have a history of thrombosis related to PNH

               -  Hereditary bone marrow failure disorders include Fanconi anemia or related
                  chromosomal breakage syndrome dyskeratosis congenita, Diamond-Blackfan anemia,
                  Shwachman-Diamond syndrome, Kostmann syndrome, congenital amegakaryocytic
                  thrombocytopenia:

                    -  Fanconi anemia or related chromosomal breakage syndrome: positive chromosome
                       breakage analysis using diepoxybutane (DEB) or mitomycin C if applicable

                    -  Dyskeratosis: diagnosis is supported by using either telomerase reverse
                       transcriptase (TERC) gene mutation in autosomal dominant Dyskeratosis
                       Congenita or Xlinked DKC1 gene mutation

               -  Other non-malignant hematologic or immunologic disorders that require
                  transplantation

                    -  Quantitative or qualitative congenital platelet disorders (including but not
                       limited to congenital amegakaryocytopenia, absent-radii syndrome,
                       Glanzmann's thrombasthenia)

                    -  Quantitative or qualitative congenital neutrophil disorders (including but
                       not limited to chronic granulomatous disease, congenital neutropenia)

                    -  Congenital primary immunodeficiencies (including but not limited to Severe
                       Combined Immunodeficiency Syndrome, Wiskott-Aldrick syndrome, CD40 ligand
                       deficiency, T-cell deficiencies)

          -  Acute leukemias:

               -  Subjects must be ineligible for conventional myeloablative transplantation;

               -  Resistant or recurrent disease after at least one standard combination
                  chemotherapy regime or first remission patients at high risk of relapse OR First
                  remission patients at high risk of relapse:

               -  Acute myeloid leukemia (AML)- antecedent myelodysplastic syndrome, secondary AML,
                  high risk cytogenetic abnormalities or normal cytogenetics with high-risk
                  molecular features (e.g. Flt3-ITD mutation, mixed-lineage leukemia [MLL],
                  wildtype NPM1);

               -  Acute lymphocytic leukemia (ALL)- high or standard risk ALL

          -  Chronic Myeloid Leukemia (CML):

               -  Chronic phase (intolerant or unresponsive to imatinib and/or other tyrosine
                  kinase inhibitors), second chronic phase or accelerated phase who are ineligible
                  for conventional myeloablative transplantation

          -  Myeloproliferative and myelodysplastic syndromes (MDS):

               -  Myelofibrosis (with/without splenectomy) with intermediate to high risk features

               -  Advanced polycythemia vera not responding to standard therapy

               -  MDS with an international prostate symptom score (IPSS) score of Int-2 or higher

               -  MDS with lower IPSS scores Int-1 or less with severe clinical features such as
                  severe neutropenia or thrombocytopenia or high risk chromosome abnormalities such
                  as monosomy 7

               -  Secondary massively parallel signature sequencing (MPSS) with any IPSS scores

               -  Chronic myelomoncytic leukemia

          -  Lymphoproliferative disease:

               -  Chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin lymphoma (NHL)
                  (recurrent or persistent) fludarabine refractory or with less than 6 months
                  duration of complete response (CR) between courses of conventional therapy

               -  Multiple myeloma, progressive disease after autologous stem cell transplant or as
                  planned tandem (allogeneic transplant after prior autologous stem cell
                  transplant)

               -  Waldenstroms macroglobulinemia (failed one standard regimen)

               -  High grade NHL and diffuse large B-cell lymphoma (DLBCL)

               -  Not eligible for conventional myeloablative HSCT OR failed autologous HSCT

               -  First remission lymphoblastic lymphoma, or small, non-cleaved cell lymphoma or
                  mantle cell lymphoma

          -  Hodgkin disease:

               -  Relapsed or refractory after front-line therapy

               -  Failed or were not eligible for autologous transplantation

          -  Failed prior autotransplant

          -  Age >= 3 and =< 75 years for blood and bone marrow transplants and age >= 3, < 60 for
             cord blood transplants

          -  No serious uncontrolled psychiatric illness

          -  No concomitant active malignancy other than non-melanoma skin cancer

          -  Non-pregnant and non-nursing women (women or men with reproductive potential should
             agree to use an effective means of birth control)

          -  Patients may have received prior autologous bone marrow transplant (BMT) or prior
             myeloablative allogeneic BMT (at least 60 days have elapsed)

          -  At least 2 weeks since prior chemotherapy, radiation treatment and/or surgery

          -  Informed consent

          -  DONOR: Permissible HLA matching: Related donors- single antigen mismatch at HLA A, B
             or DRB 1; unrelated donors- a single antigen mismatch at HLA A, B, or C, +/-
             additional single allele level mismatch at A, B, C or DRB1; cord blood >= 4 out of 6
             antigen match at HLA A, B, DRB1)

          -  DONOR: Compatibility at the four most informative HLA loci: A, B, C and DRB1 are
             important for reducing the risk of GVHD and successful transplant outcomes; the A, B,
             C and DRB1 loci comprise 8 possible alleles (a haplotype being inherited from each
             parent); one additional locus, HLA-DQ, is also typed to ascertain haplotypes and
             assist in the search for a compatible donor; however mismatching at DQ has not been
             shown to be associated with adverse outcomes; high resolution molecular typing (at the
             allele level) is now the standard of care for unrelated donor searches and allows
             greater refinement of the search strategy

          -  DONOR: Matched related donor: a single antigen mismatch at A, B, or the DR transplant
             from a family member is associated with a higher risk of GVHD but similar overall
             survival when compared to full identity at these 3 regions; related donor/recipient
             pairs must be matched at 5 of 6 HLA antigens (A, B, DRBl)

          -  DONOR: Unrelated donor: when evaluating patients for unrelated donor transplant, a
             higher degree of matching is preferred due to minimize the risk of GVHD; the A, B, C,
             DRB1 and DQ loci, comprising 10 possible alleles, will be typed routinely for all
             unrelated transplants; given the higher risk of TRM in mismatched transplants, RIT is
             often the best way to mitigate the risk; evolving data from the National Marrow Donor
             Program now makes it possible to estimate the risks of donor-recipient HLA mismatch at
             the allele or antigen level; the higher risk from HLA-mismatching must be carefully
             assessed with respect to the clinical urgency and the patient's risk by the transplant
             physician; antigen level mismatches at DQ are inconsequential to transplant outcomes
             and are ignored with respect to donor selection for the purposes of this protocol,
             with matching requirements confined to the 8 loci involving HLA A, B, C and DRB1; for
             the purpose of this protocol, a single antigen mismatch at HLA A, B, or C, with or
             without additional single allele level mismatch may participate in this protocol for
             voluntary unrelated donors (blood or marrow); patients must be at least antigen-level
             matched at DRB1

          -  DONOR: If a patient has no suitable family donor matched for 5 of 6 HLA antigens (A,
             B, DRB1) and no suitable unrelated donor is identified or for reasons of urgency, the
             patient can be considered a candidate for cord blood transplant, provided a cord blood
             donor is identified with a >= 4 out of 6 antigen match at HLA A, B, DRB1 antigens; the
             cord blood product must provide a minimum of 2 x 10^7 nucleated cells/kg, test
             negative for HIV and Hepatitis A, Band C, and sterility assays have no growth; the
             cord blood products are located through the National Marrow Donor Program, the
             American Registry, or the Bone Marrow Donor Worldwide or other established registries,
             and may be stored in the N.Y Placental Cord Blood Bank, the St. Louis Cord Blood Bank,
             or any of the established, registered International blood and marrow banks

          -  DONOR: Donor must be healthy and have nonreactive test results for all infectious
             disease assays as required by state and federal regulations; donors who screen
             seropositive for hepatitis and/or syphilis must be cleared by infectious disease
             consultation

          -  DONOR: The donor must have no uncontrolled cardiopulmonary, renal, endocrine, hepatic
             or psychiatric disease to render donation unsafe

          -  DONOR: The donor must be able to give informed consent for peripheral blood stem cell
             collection or bone marrow collection

          -  DONOR: Syngeneic donors are not eligible

          -  DONOR: Donors who have poor peripheral venous access, may require central venous line
             placement for stem cell apheresis

        Exclusion Criteria:

          -  Uncontrolled central nervous system (CNS) disease (for hematologic malignancies)

          -  Karnofsky (adult) or Lansky (for =< 16 years) performance status =< 50%

          -  Diffusing capacity of the lung for carbon monoxide (DLCO) less than 40% predicted,
             corrected for hemoglobin (Hb) and/or alveolar ventilation

          -  Cardiac: left ventricular ejection fraction less than 40%

          -  Bilirubin >= 3 x upper limit of normal

          -  Liver alkaline phosphatase >= 3 x upper limit of normal

          -  Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase
             (SGPT) >= 3 x upper limit of normal

          -  Child's class B and C liver failure

          -  Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula
             for adults or the Schwartz formula for pediatrics

          -  Patients who have received maximally allowed doses (given in 2 Gy fractions, or
             equivalent) of previous radiation therapy to various organs as follows:

               -  Mediastinum 40 Gy

               -  Heart (any volume) 36 Gy

               -  Whole lungs 12 Gy

               -  Small bowel (any volume) 46 Gy

               -  Kidneys 12 Gy

               -  Whole liver 20 Gy

               -  Spinal cord (any volume) 36 Gy

               -  Whole brain 30 Gy Enrollment of patients who previously receive higher than
                  allowed dose of radiation to a small volume of lungs, liver, and brain will be
                  determine by the discretion of the radiation oncologist on the study

          -  Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or
             other condition which, in the opinion of treating physician, would make this protocol
             unreasonably hazardous for the patient

          -  Human immunodeficiency virus (HIV) positive

          -  Patients who in the opinion of the treating physician are unlikely to comply with the
             restrictions of allogeneic stem cell transplantation based on formal psychosocial
             screening

          -  Females of childbearing potential with a positive pregnancy test
      

Gender

All

Ages

3 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

George Chen, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00856388

Organization ID

I 118807

Secondary IDs

NCI-2009-01508

Responsible Party

Sponsor

Study Sponsor

Roswell Park Cancer Institute

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

George Chen, Principal Investigator, Roswell Park Cancer Institute


Verification Date

October 2019