Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

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and R Maintenance. 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Macroglobulinemia Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL) A Phase II Study of Perifosine in Patients With Relapsed/Refractory Waldenström’s Macroglobulinemia A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström’s Macroglobulinemia (WM) A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom’s Macroglobulinemia (WM) A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenström Macroglobulinemia, OBI-1 Thalidomide, Lenalidomide, and Rituximab for Previously Treated Waldenstrom Macroglobulinemia A Study of Belimumab in Treating Symptomatic Waldenstroms Macroglobulinaemia Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia Efficacy of Carfilzomib in Combination With Ibrutinib in Waldenström’s Macroglobulinemia Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström’s Macroglobulinemia Pomalidomide in Treating Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström’s Macroglobulinaemia Extension Study of IMO-8400 in Patients With Waldenström’s Macroglobulinemia Who Completed Study 8400-401 DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom’s Macroglobulinemia Patients Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom’s Macroglobulinemia Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström’s Macroglobulinemia (WM) Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström’s Macroglobulinemia and in IgM-MGUS Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia Perifosine in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia Randomised Trial in Waldenstrom’s Macroglobulinaemia A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom’s Macroglobulinemia (WM) Pomalidomide, Dexamethasone and Rituximab in Waldenstrom’s Macroglobulinemia Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Study of Epratuzumab (hLL2) in Patients With Waldenstrom’s Macroglobulinemia A Study for Patients That Have Been Previously Been Treated in Waldenstrom’s Macroglobulinemia or Multiple Myeloma Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom’s 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

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Official Title

Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases

Brief Summary

      This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a
      myeloablative preparative regimen (of either total body irradiation (TBI); or,
      fludarabine/busulfan for patients unable to receive further radiation). followed by a
      post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant
      cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Chronic GVHD - 1 year

Secondary Outcome

 Grade II-IV acute GVHD

Condition

Acute Leukemia

Intervention

HSCT with TBI Regimen

Study Arms / Comparison Groups

 TBI Regimen
Description:  

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

Biological

Estimated Enrollment

300

Start Date

March 30, 2018

Completion Date

November 10, 2025

Primary Completion Date

January 10, 2025

Eligibility Criteria

        -Inclusion Criteria:

          -  Age: ≤ 60 years of age

          -  Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70

          -  Consent: Voluntary written consent (adult or legally authorized representative; or
             parental/guardian)

          -  Adequate Organ Function:

               -  Renal: Creatinine <2x upper limit of normal. Patients above this limit must have
                  creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate
                  method, such as cystatin C GFR.

               -  Hepatic: Bilirubin, AST, alkaline phosphatase <4 times the upper limit of
                  institutional normal

               -  Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, > 50% of
                  predicted. For pediatric patients not able to undergo PFTs or diffusion testing:
                  O2 sat of >95% on room air

               -  Cardiac: Absence of decompensated congestive heart failure, or uncontrolled
                  arrhythmia and left ventricular ejection fraction > 45%. For children not able to
                  cooperate with MUGA or echocardiography, such should be clearly stated in the
                  physician's documentation

               -  HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be
                  evaluated by Infectious Disease (ID) and a HIV management plan establish prior to
                  transplantation

        Other Inclusion Criteria:

          -  Women of child bearing potential and sexually active males with partners of child
             bearing potential must agree to use adequate birth control for the duration of
             treatment.

          -  Donor Availability: Patients considered for transplantation must have a sufficient
             graft as based on current criteria of the University of Minnesota Blood and Marrow
             Transplantation Program

          -  Eligible Diseases and Status: Patients are eligible unless their treatment is to be
             guided by a higher priority protocol.

          -  Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small
             percentage of blasts that is equivocal between marrow regeneration vs. early relapse
             are acceptable provided there are no associated cytogenetic markers consistent with
             relapse.

          -  Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete
             remission (CR); first complete remission (CR1) in patients > 60 years old; CR1 in ≤ 60
             years old that is NOT considered as favorable-risk.

          -  Favorable risk AML is defined as having one of the following:

               -  t(8,21) without cKIT mutation

               -  inv(16) or t(16;16) without cKIT mutation

               -  Normal karyotype with mutated NPM1 and wild type FLT-ITD

               -  Normal karyotype with double mutated CEBPA

               -  Acute prolymphocytic leukemia (APL) in first molecular remission at the end of
                  consolidation

          -  Very high risk pediatric patients with AML: Patients <21 years, however, are eligible
             with (M2 marrow) with < 25% blasts in marrow after having failed one or more cycles of
             chemotherapy.

          -  Acute lymphoblastic leukemia (ALL)/lymphoma: second or greater CR; CR1 unable to
             tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1
             high-risk ALL.

          -  High risk ALL is defined as having one of the following:

               -  Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL
                  rearrangements, IKZF1

               -  30 years of age or older at diagnosis

               -  White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than
                  100,000/mcL (T-ALL) at diagnosis

               -  CNS leukemia involvement during the course of disease

               -  Slow cytologic response (>10% lymphoblasts in bone marrow on Day 14 of induction
                  therapy)

               -  Evidence of persistent immonophenotypic or molecular minimal residual disease
                  (MRD) at the end of induction and consolidation therapy

          -  Very high risk pediatric patients with ALL: patients <21 years are also considered
             high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction
             or M3 marrow at the end of induction. They are eligible once they achieve a complete
             remission.

          -  Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in
             first chronic phase (CP1) patient must have failed or be intolerant to one or more
             tyrosine kinase inhibitors.

          -  Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a
             partial remission

          -  Myeloproliferative Neoplasms/Myelofibrosis, either primary as a result of polycythemia
             vera or essential thrombocythemia, with disease risk of intermediate or high-risk
             according to DIPSS criteria. Blasts must be <10% by bone marrow aspirate morphology.

          -  Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia
             with severe pancytopenia, transfusion dependence, or high risk cytogenetics or
             molecular features. Blasts must be < 10% by a representative bone marrow aspirate
             morphology.

          -  Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone
             B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease
             progression/relapse within 12 of achieving a partial or complete remission. Patients
             who had remissions lasting > 12 months, are eligible after at least two prior
             therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be
             considered for debulking chemotherapy before transplant.

          -  Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible
             after initial therapy in CR1+ or PR1+.

          -  Diffuse large Cell NHL > CR/> PR: Patients in CR/PR with initial short remission (<6
             months) are eligible, or those who have failed/or are not eligible for autologous
             transplant.

          -  Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial
             therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year.

          -  Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response
             lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this
             protocol after initial therapy.

          -  Juvenile myelomonocytic leukemia

          -  Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR.

          -  MRD positive leukemia (AML, ALL or accelerated/blast phase CML). Selected patients in
             morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular
             evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD
             negative status.

          -  Natural Killer Cell Malignancies

          -  Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis
             Congenita

          -  Other Leukemia Subtypes: A major effort in the field of hematology is to identify
             patients who are of high risk for treatment failure so that patients can be
             appropriately stratified to either more (or less) intensive therapy. This effort is
             continually ongoing and retrospective studies identify new disease features or
             characteristics that are associated with treatment outcomes. Therefore, if new
             features are identified after the writing of this protocol, patients can be enrolled
             with the approval of two members of the study committee.

        Exclusion Criteria:

          -  Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after
             > 2 salvage regimens)

          -  CML in blast crisis

          -  Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on
             salvage therapy.

          -  Evidence of progressive disease by imaging modalities or biopsy - persistent PET
             activity, though possibly related to lymphoma, is not an exclusion criterion in the
             absence of CT changes indicating progression.

          -  Active central nervous system malignancy

          -  if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18
             years old prior myeloablative allotransplant or autologous transplant

          -  Active HIV infection or known HIV positive serology

          -  active uncontrolled infection

          -  Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D:
             known to cause harm to a fetus. Females of childbearing potential must have a negative
             pregnancy test prior to starting therapy.
      

Gender

All

Ages

N/A - 60 Years

Accepts Healthy Volunteers

No

Contacts

Shernan Holtan, MD, (612)-273-2800, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03314974

Organization ID

2015LS034

Secondary IDs

MT2015-29

Responsible Party

Sponsor

Study Sponsor

Masonic Cancer Center, University of Minnesota


Study Sponsor

Shernan Holtan, MD, Principal Investigator, Masonic Cancer Center, University of Minnesota


Verification Date

April 2022