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Collection of bone marrow aspirate from both hips. One collected using the Zimmer Biomet Biocue system and the other using the Marrow Cellution system.

Comparing the two collection systems for bone marrow aspirate

Bone Marrow Collection

Michael Keller

Karen Persons

William K Vasileff, MD

Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research,

Marrow Cellution™ vs. Traditional BMA Harvest Project

Comparison of the Constituents of Bone Marrow Aspirate and Autologous Protein Solution Collected With a Traditional and a Novel System

Compare total amount of stem cells collected from each sample

Compare total amount of cytokines collected from each samples

Compare total amount of growth factors collected from each samples

Ohio State University

Associate Professor of Clinical Orthopedics

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Mantle-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Anti-Infective Agents

Antineoplastic Agents

Antirheumatic Agents

Amino Acids

Cytarabine

Acalabrutinib

Bendamustine Hydrochloride

Rituximab

Mitogens

Antineoplastic Agents, Immunological

Immunologic Factors

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis

Bendamustine will be administered at a dose of 90 mg/m\^2 IV over 30 minutes on Days 1 and 2 of Cycles 1-3

Bendamustine

In Cycle 1, rituximab will be administered at a dose of 375 mg/m\^2 IV on Day 1 or 2 at the investigator's discretion in order to reduce the risk of a first infusion reaction. Rituximab will be given on Day 1 of Cycles 1 through 6.

The capsules should be swallowed intact with water and with or without food.

On Days 1 and 2 of Cycles 4-6, following rituximab dosing, cytarabine will be administered IV every 12 hours for a total of 4 doses.

Until collection of ≥ 2 x 106 CD34+ stem cells / kg

Leukapheresis

-Baseline, end of Cycle 3, 4-6 weeks after Cycle 6 Day 1, and if the patient discontinues protocol therapy prior to completion of Cycle 6

Peripheral blood

Oral rinse

-Bone marrow will be collected at baseline if the patient requires a marrow for staging purposes and at end of treatment if the patient requires a marrow for restaging.

Bone marrow collection

Brad S Kahl, M.D.

This study is designed to evaluate the efficacy and safety of acalabrutinib plus bendamustine and rituximab followed by acalabrutinib plus cytarabine and rituximab in subjects with treatment naïve mantle cell lymphoma (MCL), as a preparation for a larger cooperative group trial with the goal of achieving a standard induction regimen for MCL in transplant eligible patients. The investigators hypothesize that the addition of acalabrutinib to BR/CR regimen will prove safe and increase the complete response (CR) rate as well as minimal residual disease (MRD) negativity pre-transplant, thus improving clinical outcomes.

Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma

A Pilot Study of Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma

-Stem cell mobilization success is defined as a yield of \>2x10\^6 CD34+ stem cells/kg with a maximum of 5 courses of apheresis

-Toxicity is measured using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

-For definitions of CR and PR please refer to the Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification

-For definitions of CR, please refer to the Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification

* PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first
* London Deauville score of 4 or 5 in individual target nodes/masses with an increase in intensity of uptake from the baseline and/or new FDG avid foci consistent with lymphoma at interim or end of treatment assessment; New FDG avid foci of extranodal disease consistent with lymphoma. If there is concern regarding the etiology of the new lesions, biopsy or interval scan may be considered; New or recurrent FDG avid foci in the bone marrow

-OS=time from study registration until death from any cause

Acerta Pharma BV

Washington University School of Medicine

Bendamustine/Rituximab/Acalabrutinib/Cytarabine

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Brad S. Kahl, M.D.

9 participants are not evaluable because they did not receive stem cell transplant.

Stem Cell Mobilization Success Rate With Cytarabine and Rituximab

Diarrhea

Infusion related reaction

Upper respiratory infection

Skin infection

Perirectal abscess

Peritoneal infection

Blood bilirubin increased

Ejection fraction decreased

Alanine aminotransferase increased

Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher

1 participant did not complete 2 cycles and was not evaluable for response

Overall Response Rate (ORR = Complete Response (CR) + Partial Response (PR)) of Subjects

Pre-transplant Complete Response Rate

Progression-free Survival (PFS)

Overall Survival (OS)

Overall Study

Syndrome

Preleukemia

Myelodysplastic Syndromes

Anemia

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Single arm open label study. Patient receive 100 mg APG101 i.v. weekly over 12 weeks with a 6 monthly follow-up phase

Patients will be treated 12 weeks with 100 mg APG101 intravenous weekly

Treatment with APG101

During the study, bone marrow will be collected 4 times to assess study objectives

During the study, blood will be drawn at different time points to assess study objectives

Blood drawings

Florian Nolte, MD

It has been shown in preclinical experiments with bone marrow from patients with myelodysplastic syndrome that APG101 rescues erythrocytes from premature cell death. This is expected to translate in an improved erythropoiesis and ameliorated anemia in MDS patients.

APG101 might, therefore, be a valuable addition to current treatments of low- or intermediate MDS patients suffering from anaemia.

Transfusion-dependent patients with low or intermediate risk MDS according to WHO Prognostic Scoring Scale (WPSS) can be included in this study.

Treatment consists of 100mg APG101 intravenous as a weekly treatment over 12 weeks + 6 months follow up phase.

Primary objective of the trial is safety and tolerability of APG101; secondary objectives are

* Hematologic, cytologic and cytogenetic response rate using modified International Working Group (IWG) response criteria
* Incidence and time to leukemic progression at 37 weeks
* OS (Overall survival) at 37 weeks

APG101 in Myelodysplastic Syndrome

APG101 in Transfusion-Dependent Patients With Low or Intermediate Risk Myelodysplastic Syndrome

Evaluation of adverse events (AEs) and serious adverse events (SAEs). Evaluation of electrocardiograms (ECGs), abdominal ultrasound, anti-drug antibodies (ADA), changes in lymphocyte subpopulations / activation markers and changes in performance status (ECOG).

Any side effects potentially related to the APG101 treatment are evaluated.

Overall survival (OS) is defined as time from start of study treatment to death from any cause

Changes in transfusion frequency will be evaluated as those are early signs of an improval in erythropoiesis

By assessing different parameters (cytologic, hematologic, cytogenetic), safety as well as efficacy of treatment with APG101 can be evaluated

Changes in Hb level will be evaluated as those are early signs of an improval in erythropoiesis

Apogenix GmbH

Nutritional and Metabolic Diseases

Amyloidosis

Immunoglobulin Light-chain Amyloidosis

Neoplasm, Residual

Proteostasis Deficiencies

Metabolic Diseases

Neoplastic Processes

Neoplasms, Plasma Cell

Paraproteinemias

AL Amyloidosis

Melphalan

Bone marrow collection and peripheral blood collection from ten patients with untreated AL amyloidosis will be evaluated to determine feasibility of isolating a plasma cell clone. An additional three teaspoons of bone marrow and 4 teaspoons of blood will be collected at the time of standard blood draw and bone marrow biopsy before receiving any treatment. There will be no extra procedures or visits specifically for this research.

If feasibility is determined with initial cohort, bone marrow collection and peripheral blood collection from 20 patients with untreated AL amyloidosis who are scheduled to undergo antineoplastic therapy will be evaluated to isolate a plasma cell clone. An additional 3 teaspoons of bone marrow and 4 teaspoons of blood will be collected at the time of standard blood draw and bone marrow biopsy before receiving therapy. For those who complete therapy and achieve complete response or very good partial response, subsequent samples of bone marrow and peripheral blood will be sent for minimal residual disease detection (based on the previously identified cancer clone) at 6 to 12 months post treatment.

blood collection

bone marrow collection

Shayna Sarosiek, MD

In this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if Minimal Residual Disease (MRD) can be used as a predictive method of response to treatment in amyloidosis.

In this study, the investigators seek to evaluate bone marrow and blood samples and treatment responses to see if Minimal Residual Disease (MRD) (as described below), can be used as a predictive method of response to treatment in amyloidosis.

Minimal residual disease (MRD) is a concept that has gained significant value as a prognostic predictor and has become an emerging constituent of complete response (CR) reassessment in multiple myeloma (MM) patients. Studies in MM have demonstrated that up to 30% of patients achieving a CR after high-dose therapy will still have detectable MRD in the bone marrow as measured by standard-sensitivity flow cytometry or by molecular assays. Virtually every study examining MRD in MM has reported that among patients achieving a CR, those who were MRD negative (MRD-) had a significantly superior progression-free survival, with some studies reporting superior overall survival.

As amyloidosis is a disease that is very similar to multiple myeloma, the investigators wish to evaluate the concept in this disease.

Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment in Patients With AL Amyloidosis

Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment (Which May Include High Dose Melphalan and Autologous Stem Cell Transplantation (HDM/SCT)) in Patients With AL Amyloidosis: Feasibility and Prognostic Significance

Number of samples that have a successful isolation of a plasma cell clone

Number of cases in which minimal residual disease observed in specimens correlates

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Marrow Cellution™ vs. Traditional BMA Harvest Project	NCT06388993	Hip Arthropathy Avascular Necro... Subchondral Cys...	Bone Marrow Col...	18 Years - 50 Years	Ohio State University
Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma	NCT03623373	Mantle Cell Lym...	Bendamustine Rituximab Acalabrutinib Cytarabine Leukapheresis Peripheral bloo... Oral rinse Bone marrow col...	18 Years - 70 Years	Washington University School of Medicine
APG101 in Myelodysplastic Syndrome	NCT01736436	Myelodysplastic...	Treatment with ... Bone marrow col... Blood drawings	18 Years -	Apogenix AG
Assessment of Minimal Residual Disease (MRD) After Antineoplastic Treatment in Patients With AL Amyloidosis	NCT02716103	Amyloidosis	blood collectio... bone marrow col...	18 Years -	Boston Medical Center
APG101 in Myelodysplastic Syndrome	NCT01736436	Myelodysplastic...	Treatment with ... Bone marrow col... Blood drawings	18 Years -	Apogenix AG

Spots Global Cancer Trial Database for bone marrow collection