Symptoms and General Pathology

All Conditions

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Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Lymphoma

Myeloproliferative Disorders

Bone Marrow Diseases

Hematologic Diseases

Lymphosarcoma

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Sirolimus

Patients enrolled and treated with PTCy/sirolimus plus VIC-1911

25 mg, 50 mg, or 75 mg administered twice a day from day 5 post HCT to day 45, and the dose escalation will stop once we identify the lowest biologically active and safe dose of VIC.

VIC- 1911

Cancer Center Clinical Trials Office

Sherman Holtan, MD

This is a single-arm, phase I/II, study of PTCy/sirolimus plus VIC-1911 to prevent GVHD and relapse after Allogeneic Hematopoietic Cell Transplantation (alloHCT).

Determination of the optimal dose during the Phase I trial is based on Dose Limiting Toxicity for safety and reduction of CD4+, pH3ser10+ T cells (phosphorylated histone 3 serine 10 is a biomarker of Aurora kinase A activity) for efficacy. Phase II will be powered to improve grade III-IV acute graft-versus-host disease and relapse after alloHCT, compared to historical estimates at the University of Minnesota.

Patients will receive myeloablative conditioning (MAC) with total body irradiation (TBI) followed by infusion of HLA-matched related or unrelated peripheral blood stem cells (PBSC) on day 0. Cyclophosphamide will be administered on days +3 and +4. Sirolimus targeting 8-12ng/ml will begin on day +5 until day +365. VIC-1911 will be administered as 25 mg, 50 mg, or 75 mg orally BID from day +5 to day +45 according to the rules of our phase I study. The lowest biologically active and safe dose of VIC-1911 will be identified as the recommended phase II dose.

PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation

The optimal dose will be identified using the EffTox design. The proportion of patients with an average CD4+, pH3ser10+ T cell of \<54%. The minimum desired biologic efficacy is 65% of patients by day 21 (+/- 3 days) with \<30% of patients experiencing a DLT.

Assessment to determine if patient has relapse

Determine the frequency of CD4+, pS6+ \[marker of mTOR activity\] and CD4+, pSTAT5+ \[marker of IL-2 activity\] cells

GRFS defined as grade III-IV acute GVHD, chronic GVHD requiring immunosuppression, relapse, or death by 1 year

Comparison hospitalization days with another trial's data (MT2015-29)

Use quality of life questionnaire to measure patients' quality of life.

Masonic Cancer Center, University of Minnesota

Hematologic Neoplasms

Graft vs Host Disease

Homologous Wasting Disease

Antirheumatic Agents

Cyclophosphamide

Thymoglobulin

Antilymphocyte Serum

low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-3-d-2 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3

low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-2-d-1 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3

group A:low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-3-d-2 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3 group B:low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-2-d-1 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3

yang, master

xianming song, doctor

YANG JUN, master

song xianmin, doctor

xinpeng wang, doctor

Low dose Rabbit Antithymocyte Globulin plus Low-dose post-transplantation cyclophosphamide as graft-versus-host disease prophylaxis in haploidentical hematopoietic stem cell transplantation for patients with hematologic malignancies

A novel regimen, which is composed of a low dose of ATG (5 mg/kg) and low-dose PTCy (one dose of PTCy, 50mg/kg) for GVHD prophylaxis in haplo-HSCT for patients with hematologic malignancies, is going to be evaluated in the prospective, randomized control, phase II clinical trial. It is theoretically feasible because the mechanisms of ATG and Cyclophosphamide on T lymphocyte are different. ATG plays the immunosuppressive activity on the depletion of peripheral T lymphocytes through complement dependent lysis or activation-associated apoptosis. ATG also modulates cell-surface expression of surface adhesion molecules or chemokine receptors. In addition, ATG can also affect or interfere with the function of different immune cells such as B lymphocytes, regulatory T lymphocytes (Treg), natural killer (NK)-T lymphocytes and dendritic cells (DC).Cyclophosphamide is nontoxic to hematopoietic stem cells and can selectively deplete the alloreactive T cells. Therefore, we hypothesis that ATG followed by PTCy have the synergistic effect on GVHD prophylaxis. (2) Luznik et al also showed that there was no difference in the incidence of severe acute GVHD between one or two doses of PTCy. Furthermore, there was a trend toward a lower incidence of extensive cGVHD among patients of two doses of PTCy compared with one dose PTCy. One dose of PTCy might preserve the GVL effect without influencing the incidence of the severe aGVHD. (3) Y Wang et al reported a randomized clinical trial comparing two different doses of ATG (6 and 10mg/kg) as GVHD prophylaxis for Haplo-HSCT. There was no difference in the median myeloid and platelet engraftment time and the rate of graft failure. The results showed that the incidence of grade III-IV acute GVHD was higher in the ATG-6 group than in the ATG-10 group. But the EBV reactivation occurred more frequently in the ATG-10 group than in the ATG-6 group. The higher rate of infection and NRM may influence the transplant outcomes in this GVHD prophylaxis strategy. We speculated that low dose of ATG (5 mg/kg) will ensure the engraftment and decrease infection frequency. But the optimal timing of ATG administration still needed to be considered. The immunosuppressive activity of ATG is not only dose-dependent but also rely on the timing of drug administration, especially when the lower dose of ATG was used as GVHD Prophylaxis. So we designed a randomized control phase II study to evaluate the efficacy and toxicity with low dose ATG followed by low dose PTCy as GVHD prophylaxis .

Low Dose ATG Plus Low Dose PTCy as GVHD Prophylaxis in Haplo-HSCT

Low Dose Rabbit Antithymocyte Globulin Plus Low-dose Post-transplantation Cyclophosphamide as GVHD in Hapl-HSCT for Patients With Hematologic Malignancies: a Phase II Trial

The cumulative incidences of aGvHD was defined as the number and the ratio of the participants with aGVHD

Leukocyte engraftment:(was defined as the first of three consecutive days of peripheral white blood count \>1000/ul.

Platelet engraftment:(was defined as the first of seven consecutive days of platelet counts of \>50000/ul.

Quantitative chimerism analyzes were performed using short-tandem-repeat-based polymerase chain reaction technique sat regular intervals for every 4 weeks after allografting in bone marrow.

RI was defined as the number and ratio of the participants with relapse after transplantation

cGvHD was diagnosed and graded according to the 2014 National Institutes of Health (NIH) consensus criteria: mild, moderate or severe respectively.The number and ratio of participants with cGVHD after transplatation

CMV and EB infections(The number and ration of participants with infection after transplantaton)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Head of Hematology

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Fludarabine

Fludarabine phosphate

Mycophenolic Acid

Tacrolimus

Busulfan

Immunosuppressive Agents

Immunologic Factors

Calcineurin Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Conditioning:

fludarabine 180 mg/m2 busulfan 8-14 mg/kg per os

GVHD prophylaxis:

cyclophosphamide 50 mg/kg day+3, +4 tacrolimus 0.03 mg/kg from day+5 to 100 mycophenolate mofetil 30 mg/kg from day+5 to 35

Conditioning:

fludarabine 180 mg/m2 busulfan 8-14 mg/kg per os ruxolitinib 5 mg tid days -7 to -2

GVHD prophylaxis:

cyclophosphamide 50 mg/kg day+3, +4 ruxolitinib 5 mg tid days +5 to +21 ruxolitinib 5 mg bid days +22 to +150

Ruxolitinib administered during conditioning 5 mg tid before allogeneic hematopoietic stem cell transplantation, 5 mg tid days 5-21 and 5 mg bid days 22-150 after transplantation instead of tacrolimus and MMF.

Ruxolitinib

Tacrolimus 0.03 mg/kg adjusted to concentrations 5-15 ng/ml from day+5 to +100

Mycophenolate mofetil 30 mg/kg from day +5 to +35

Mycophenolate Mofetil

This is multicenter investigator-initiated randomized open-label phase II clinical trial to compare prophylaxis of graft versus host disease treated with tacrolimus and mycophenolate mofetil versus ruxolitinib after post-transplant cyclophosphamide.

In total 128 patients will be included in the study. After inclusion into the study and performing of transplantation patients will be randomized in 1:1 proportion in two arms (64 patients per arm): arm A will include patients who will be treated with cyclophosphamide and ruxolitinib for GVHD prophylaxis; arm B will include patients who will be treated with cyclophosphamide, tacrolimus and MMF for GVHD prophylaxis. After the end of the treatment patients will be followed-up during two years.

PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT

A Randomized, Multicenter, Open-label Phase II Trial to Compare Prophylaxis of Graft Versus Host Disease With Tacrolimus and Mycophenolate Mofetil Versus Ruxolitinib After Post-transplant Cyclophosphamide

Proportion of patients with acute GVHD II-IV grade

Cumulative incidence of patients with mortality without hematological relapse of malignancy

Cumulative incidence of patients with relapse

Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria

Kaplan-Meier estimate of death from all causes

Kaplan-Meier estimate of death or relapse

Toxicity assessment is based on NCI CTC AE 5.0 grades. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2016. Transplant-associated microangiopathy incidence assessment is based on Cho et al. criteria. All toxicity measurements will be aggregated as severity scores.

Cumulative incidence of patients with primary or secondary graft failure defined by the absence of donor chimerism.

Number of patients with bacteremia before engraftment, bacteremia after engraftment, severe sepsis (presence of multiple organ failure), pneumonia, soft tissue infection, invasive mycosis (probable or proven invasive aspergillosis, candidaemia, zygomycosis), reactivation of cytomegalovirus, other opportunistic viral infections

St. Petersburg State Pavlov Medical University

RM Gorbacheva Research institute scientific director

Infections

Heart and Blood Diseases

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Leukemia, Prolymphocytic

Primary Myelofibrosis

Burkitt Lymphoma

Anemia, Refractory, with Excess of Blasts

Leukemia, Plasma Cell

Leukemia, Biphenotypic, Acute

Anemia

Anemia, Refractory

Lymphoma, Non-Hodgkin

Precancerous Conditions

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphoma, B-Cell

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Multiple Myeloma

Neoplasms, Plasma Cell

Chronic Graft Versus Host Disease

Peripheral T-cell Lymphoma

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Follicular Lymphoma

Marginal Zone Lymphoma

Acute Leukemia of Ambiguous Lineage

Myelodysplastic Syndrome With Excess Blasts

Plasma Cell Leukemia

B-cell Lymphoma

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Allopurinol

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Clotrimazole

Miconazole

Antifungal Agents

Antioxidants

Protective Agents

Tannic Acid

On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.

Peripheral Blood Stem Cell Transplant

300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.

Allopurinol 300 MG

30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.

Administered as a 2 hour IV infusion on day -6, +3, and +4.

On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.

Bone Marrow Cell Transplant

The dose of TBI will be 200 cGy given in a single fraction on day -1.

Total Body Irradiation

All participants begin +5 to day +100.

Loading dose on day +5 of 5 mg/m2/day orally once (max dose of 8 mg).

Maintenance dose 2.5 mg/m2 orally daily to maintain a level of 8-12 ng/ml (max dose of 4 mg).

Sirolimus Pill

All patients begin day +5 through day +35.

3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (maximum of 1 gram per dose) every 8 hours.

Mark Juckett

This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.

Allo HSCT Using RIC and PTCy for Hematological Diseases

Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Number of participants with GVHD grades 2-4 after one year post transplant.

Number of participants with chronic GVHD after one year post transplant.

Number of participants that experienced relapse within 100 days of treatment.

Observe overall participant survival at Day 100 and at 1 and 3 years

Number of participants with transplant related mortality within 12 months of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation	NCT05120570	Acute Leukemia Myelodysplastic... Myeloproliferat... Lymphoma	VIC- 1911	18 Years -	Masonic Cancer Center, University of Minnesota
Low Dose ATG Plus Low Dose PTCy as GVHD Prophylaxis in Haplo-HSCT	NCT03395860	Graft-versus-ho... Prophylaxis	ATG	14 Years - 70 Years	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT	NCT04669210	Graft-versus-ho... Stem Cell Trans... Acute Myeloid L... Acute Lymphoid ...	Ruxolitinib Tacrolimus Mycophenolate M...	18 Years - 70 Years	St. Petersburg State Pavlov Medical University
PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation	NCT05120570	Acute Leukemia Myelodysplastic... Myeloproliferat... Lymphoma	VIC- 1911	18 Years -	Masonic Cancer Center, University of Minnesota
PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation	NCT05120570	Acute Leukemia Myelodysplastic... Myeloproliferat... Lymphoma	VIC- 1911	18 Years -	Masonic Cancer Center, University of Minnesota
Allo HSCT Using RIC and PTCy for Hematological Diseases	NCT05805605	Acute Myelogeno... Acute Lymphocyt... Biphenotypic Ac... Undifferentiate... Prolymphocytic ... Chronic Myeloge... Plasma Cell Leu... Myelodysplastic... Leukemia, Myelo... Myelodysplastic... Burkitt Lymphom... Relapsed T-Cell... Relapsed Chroni... Small Lymphocyt... Marginal Zone L... Follicular Lymp... Myeloproliferat... Myelofibrosis	Peripheral Bloo... Allopurinol 300... Fludarabine Cyclophosphamid... Bone Marrow Cel... Total Body Irra... Sirolimus Pill Mycophenolate M...	- 75 Years	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for ptcy

Every month we try and update this database with for ptcy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ptcy

Every month we try and update this database with for ptcy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ptcy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.