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Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced My...

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis (MF) and other myeloid neoplasms.

DRUG: INCB057643

DRUG: Ruxolitinib

Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Und...

This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therap...

DRUG: Fludarabine

RADIATION: Total-Body Irradiation

PROCEDURE: Donor Lymphocyte Infusion

DRUG: Cyclophosphamide

DRUG: Tacrolimus

DRUG: Mycophenolate Mofetil

PROCEDURE: Hematopoietic Cell Transplantation

DRUG: Melphalan

PROCEDURE: Bone Marrow Aspiration and Biopsy

PROCEDURE: Diagnostic Imaging

PROCEDURE: Biospecimen Collection

A Study of Oral Nuvisertib (TP-3654) in Patients with Myelofibrosis

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.

DRUG: Nusivertib

DRUG: Ruxolitinib

DRUG: Momelotinib

Allo HSCT Using RIC and PTCy for Hematological Diseases

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 ce...

BIOLOGICAL: Peripheral Blood Stem Cell Transplant

DRUG: Allopurinol 300 MG

DRUG: Fludarabine

DRUG: Cyclophosphamide

BIOLOGICAL: Bone Marrow Cell Transplant

RADIATION: Total Body Irradiation

DRUG: Sirolimus Pill

DRUG: Mycophenolate Mofetil

Study of DISC-0974 in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia

This phase 1b/2a open-label study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of DISC-0974 as well as categorize the effects on anemia response in subjects with myelofibrosis or myelodysplastic syndrome and anemia.

DRUG: DISC-0974

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera My...

AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), clinical activity and changes in biomarkers of an orally administered type II...

DRUG: AJ1-11095

Ruxolitinib Phosphate and Azacytidine in Treating Patients With Myelofibrosis or Myelodysplastic Syn...

This phase II trial studies how well ruxolitinib phosphate and azacytidine work in treating patients with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm. Ruxolitinib phosphate may stop the growth of cancer cells by blocking som...

DRUG: Azacitidine

OTHER: Laboratory Biomarker Analysis

DRUG: Ruxolitinib Phosphate

A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative N...

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.

DRUG: INCB160058

Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition

This is a prospective phase I dose-escalation study, with the primary objective to access the MTD and find the RP2D of talazoparib, given in combination with standard of care dosing of pacritinib.

DRUG: Talazoparib

DRUG: pacritinib

Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF W...

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those w...

DRUG: TL-895

DRUG: Ruxolitinib

Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase M...

This phase II trial studies how well decitabine with ruxolitinib, fedratinib, or pacritinib works before hematopoietic stem cell transplant in treating patients with accelerated/blast phase myeloproliferative neoplasms (tumors). Drugs used in chemoth...

DRUG: Decitabine

DRUG: Ruxolitinib

DRUG: Fedratinib

OTHER: Questionnaire Administration

DRUG: Pacritinib

Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm

The primary objective of this study is to assess the safety and tolerability of administrating mutated-CALR peptide Vaccine to patients with MPN. The researchers plan to enroll 10 patients over a 12 month period. Maximum length of participation in 80...

DRUG: Peptide-based vaccine

DRUG: Poly ICLC

A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or Hi...

The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory (R/R) to Janus Kinase (JAK)-Inhibi...

DRUG: Imetelstat

DRUG: Best Available Therapy (BAT)

HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation with Reduced Dose Post Tra...

The goal of this clinical trial is to determine the effectiveness of Reduced Dose Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question\[s\] it a...

DRUG: Busulfan

DRUG: Fludarabine

PROCEDURE: PBSC Hematopoietic Stem Cell Transplantation (HSCT)

DRUG: Post-Transplant Cyclophosphamide

DRUG: Mesna

DRUG: Tacrolimus

DRUG: Mycophenolate Mofetil

OTHER: Patient Reported Outcomes

DRUG: Melphalan

RADIATION: Total-body irradiation

DRUG: Cyclophosphamide

Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Ph...

This phase I/II trial studies the best dose of ruxolitinib when given together with CPX-351 and to see how well they work in treating patients with accelerated phase or blast phase myeloproliferative neoplasm. Ruxolitinib may stop the growth of cance...

PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation

DRUG: Liposome-encapsulated Daunorubicin-Cytarabine

DRUG: Ruxolitinib

Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatm...

DRUG: KRT-232

DRUG: TL-895

Allogeneic Hematopoietic Cell Transplantation With Pegylated Interferon Alfa-2a for Primary and Seco...

This is a single site, open-label, dose de-escalation, Phase 1 study of pegylated interferon alfa-2a administered after alloHCT in subjects with primary or secondary myelofibrosis. Part 1 of the study will assess the rate of dose-limiting toxicities ...

DRUG: Pegylated interferon alpha2a

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelst...

The purpose of the study is to identify the recommended Part 2 dose (R2PD) of imetelstat in combination with ruxolitinib in participants with myelofibrosis (MF) in Part 1, and to evaluate the safety and clinical activity of the R2PD of imetelstat in ...

DRUG: Imetelstat

DRUG: Ruxolitinib

KRT-232 in Combination With TL-895 for the Treatment of R/R MF and KRT-232 for the Treatment of JAKi...

This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

DRUG: KRT-232

DRUG: TL-895

Open Label Phase 2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythe...

To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF.

DRUG: Ruxolitinib

DRUG: Tasquinimod

Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders

The main purpose of this study is to examine the outcome of a combined bone marrow and kidney transplant from a partially matched related (haploidentical or "haplo") donor. This is a pilot study, you are being asked to participate because you have a ...

PROCEDURE: Haploidentical Bone Marrow/Kidney

Study of Canakinumab in Patients With Myelofibrosis

This is an open label, multicenter, phase 2 trial of Canakinumab in patients with primary myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/PV MF). Eligible patients will receive Canakinumab administered as a s...

DRUG: Canakinumab

A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms

This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered in participants with myeloprolif...

DRUG: INCA033989

A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malign...

This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

BIOLOGICAL: OrcaGraft (Orca-Q)

High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Spleno...

To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed.

DRUG: Ruxolitinib

PROCEDURE: Allogeneic Stem Cell Transplantation

DRUG: Levetiracetam

DRUG: Eltrombopag

DRUG: Busulfan

DRUG: Romiplostim

DRUG: Fludarabine phosphate

DRUG: Cyclophosphamide

DRUG: Mesna

DRUG: Tacrolimus

Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant

The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation. This study will also determine if hyperbaric oxygen therapy improves engraftment, graft versus host disease, neutrophil count,...

DRUG: Hyperbaric oxygen

Study of Navtemadlin Add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Ha...

This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subje...

DRUG: Navtemadlin

DRUG: Navtemadlin placebo

DRUG: Ruxolitinib

A Study of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thr...

The main purpose of this study with corresponding optional expansion is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy...

DRUG: Selinexor 60 mg

DRUG: Selinexor 40 mg

DRUG: Ruxolitinib

DRUG: Pacritinib

DRUG: Momelotinib

Study of Tagraxofusp for Post-Transplant Maintenance for Patients With CD 123+ AML, MF and CMML (HSC...

In this study, tagraxofusp (Tag) is given to patients with CD 123+ myelofibrosis (MF), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) after allogeneic stem cell transplant (HCT) to help prevent relapse. Patients will receive...

DRUG: Tagraxofusp

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Mye...

DRUG: TL-895

DRUG: Placebo

MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial

Low-dose MTX is a widely used, inexpensive, and safe therapy used for decades and is well tolerated by patients with rheumatologic diseases. Recently, it was identified as a type 2 JAK inhibitor. If MTX proves to be safe and tolerable with a signal o...

DRUG: Methotrexate (MTX)

Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Dis...

This is a treatment guideline for an unrelated umbilical cord blood transplant (UCBT) using a myeloablative preparative regimen for the treatment of hematological diseases, including, but not limited to acute leukemias. The myeloablative preparative ...

DRUG: Fludarabine

DRUG: Cyclophosphamide

RADIATION: Total Body Irradiation

DRUG: Cyclosporine A

DRUG: Mycophenylate mofetil

BIOLOGICAL: Umbilical cord blood

Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibr...

This initial cohort of this phase II trial studied the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). The primary risk of using Haplo H...

DRUG: Cyclophosphamide

DRUG: JAK Inhibitor

DRUG: Fludarabine

BIOLOGICAL: Recombinant Granulocyte Colony-Stimulating Factor

DRUG: Melphalan

DRUG: Mycophenolate Mofetil

PROCEDURE: Peripheral Blood Stem Cell Transplantation

DRUG: Tacrolimus

RADIATION: Total-Body Irradiation

PROCEDURE: Computed Tomography

PROCEDURE: Magnetic Resonance Imaging

PROCEDURE: Bone Marrow Biopsy

PROCEDURE: Bone Marrow Aspiration

PROCEDURE: Biospecimen Collection

PROCEDURE: Echocardiography

PROCEDURE: Multigated Acquisition Scan

Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when combined with the standard dose of azacitidine. Treatment will begin within 28 days of screening procedures. Treatment will continue indefinitely, provided ...

DRUG: Azacitidine

DRUG: Selumetinib

Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MP...

This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 sub...

DRUG: LP-118

A Safety and Tolerability Study of Jaktinib

This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.

DRUG: Jaktinib Hydrochloride Tablet

Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders

This is a single-arm study to investigate 1-year treatment related mortality (TRM) in patients with life threatening non-malignant and malignant hematologic disorders who do not have a matched related donor for allogeneic transplantation.

DRUG: Clofarabine

DRUG: Fludarabine

DRUG: Busulfan

DRUG: Cyclosporine-A

DRUG: Mycophenolate Mofetil

BIOLOGICAL: Cord Blood Graft

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Ane...

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependen...

DRUG: INCB000928

DRUG: ruxolitinib

Study of Selinexor in Combination with Ruxolitinib in Myelofibrosis

This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and...

DRUG: Selinexor

OTHER: Placebo

DRUG: Ruxolitinib

KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relap...

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. Th...

DRUG: KRT-232

DRUG: Best Available Therapy (BAT)

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasm...

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968, in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s), in part...

DRUG: JNJ-88549968

Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic ...

This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies ...

DRUG: Darzalex Faspro (Daratumumab and hyaluronidase-fihj)

DEVICE: JH-DSA Semi-Quant Screen and Response Score

Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs

To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib

DRUG: CK0804

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infect...

This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients ...

PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation

PROCEDURE: Biospecimen Collection

DRUG: Granulocyte Colony-Stimulating Factor

DRUG: Hematopoietic Cell Transplantation Conditioning Regimen

BIOLOGICAL: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine

PROCEDURE: Pheresis

DRUG: Placebo Administration

DRUG: Stem Cell Mobilization Therapy

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (AC...

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: * Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who...

DRUG: Luspatercept

Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis

This phase II trial studies how well administering ruxolitinib before, during, and after allogeneic hematopoietic stem cell transplantation works in preventing graft versus host disease and improving transplant outcomes in patients with primary and s...

PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation

DRUG: Busulfan

DRUG: Cyclophosphamide

DRUG: Fludarabine

DRUG: Melphalan

DRUG: Methotrexate

DRUG: Mycophenolate Mofetil

DRUG: Ruxolitinib

DRUG: Tacrolimus

RADIATION: Total-Body Irradiation

PROCEDURE: Computed Tomography

PROCEDURE: Echocardiography

PROCEDURE: Bone Marrow Aspiration and Biopsy

PROCEDURE: Magnetic Resonance Imaging

PROCEDURE: Ultrasound Imaging

Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Sign...

This phase II trial evaluates how a curcumin supplement (C3 complex/Bioperine) changes the inflammatory response and symptomatology in patients with clonal cytopenia of undetermined significance (CCUS), low risk myelodysplastic syndrome (LR-MDS), and...

PROCEDURE: Biospecimen Collection

PROCEDURE: Bone Marrow Aspiration

PROCEDURE: Bone Marrow Biopsy

DIETARY_SUPPLEMENT: Curcumin/ Demethoxycurcumin/Bisdemethoxycurcumin-containing Supplement

DIETARY_SUPPLEMENT: Piperine Extract (Standardized)

DRUG: Placebo Administration

OTHER: Questionnaire Administration

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

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...

BIOLOGICAL: HSCT with TBI Regimen

BIOLOGICAL: HSCT with Non-TBI Regimen

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use i...

DRUG: Bomedemstat

Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Ma...

A Phase 1, first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies

DRUG: EP31670

An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms

This is a phase I/II study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).

DRUG: N-Acetylcysteine

Reparixin in Patients with Myelofibrosis Myeloproliferative Neoplasms Research Consortium (MPN-RC 12...

This is an open label, phase II study to assess the efficacy, safety, and tolerability of Reparixin in patients with DIPSS intermediate-2, or high-risk primary myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/...

DRUG: reparixin

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