Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Lenalidomide

Immunoglobulins

Lintuzumab

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Immunological

4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle

lintuzumab

10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle

lenalidomide

Eric Sievers, MD

This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.

A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)

A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)

Seagen Inc.

Leukemia

Cytopenia

Anemia

Neoplasms by Histologic Type

Hypoglycemic Agents

Metformin

2000 mg/day metformin for 12 months (1000 mg b.i.d.) with a slow up-titration six weeks prior to full dose treatment.

Kirsten Grønbæk, Professor, MD

Stine Ulrik Mikkelsen, MD

This is a single-arm pilot study of the feasibility and safety of metformin in patients with clonal cytopenia of undetermined significance (CCUS) or lower-risk myelodysplastic neoplasms (LR-MDS).

The research plan is divided into three work packages (WP):

WP0: Bone Marrow Adipose Tissue, Gut Microbiota, and Intestinal Permeability in CCUS and LR-MDS Patients.

The aim of WP0 is to investigate biological features which the investigators hypothesize to be of pathogenetic relevance for MDS progression and may be possible targets of metformin treatment. For this purpose, 20 elderly (≥60 years) healthy controls will be included for comparison to patients with CCUS or LR-MDS from WP1.

The primary objectives are to investigate 1) the abundance and properties of bone marrow adipose tissue (BMAT) and bone marrow (BM) adipocytes, and 2) the gut microbiota and intestinal permeability of patients with CCUS or LR-MDS compared to age-, sex- and body mass index (BMI)-matched healthy controls. Secondary objectives are to characterize DNA methylation and hydroxymethylation (5-mC and 5-hmC) patterns, and hormone and cytokine levels in BM plasma from healthy controls and patients with CCUS or LR-MDS.

WP1: Safety, feasibility, and mechanisms of action of metformin in patients with CCUS or LR-MDS.

In this WP up to 40 patients with CCUS or LR-MDS will receive metformin 2000 mg daily or their maximum tolerated dose (MTD) for 12 months. The aim of WP1 is to investigate safety of metformin and feasibility of the protocol in patients with CCUS or LR-MDS. Potential mechanisms of anti-leukemic action of metformin will also be explored in order to identify a suitable outcome measure and estimate standard deviation of the outcome measure. All in order to inform the design of a future phase 3 RCT of the efficacy of metformin in CCUS and LR-MDS patients. Endpoints of WP1 are specified in the corresponding section.

WP2: Safety and efficacy of metformin compared to placebo. The primary objective of WP2 is to compare safety and preliminary efficacy of metformin in patients with CCUS or LR-MDS to a cohort of patients with CCUS or LR-MDS receiving placebo in context of our EVI-2 randomized, controlled pilot study (NCT03999723).

Data and samples from approximately 50 historical controls will be included from the EVI-2 study in which participants were randomized to receive placebo or oral vitamin C supplement for 12 months.

Repurposing Metformin as a Leukemia-preventive Drug in CCUS and LR-MDS

STOP-LEUKEMIA: Repurposing Metformin as a Leukemia-preventive Drug in CCUS and LR-MDS

To assess safety of metformin treatment in this off-label indication by the type, grade, and number of adverse events and serious adverse events including any suspected unexpected serious adverse reactions in the patients.

To assess safety of metformin treatment in this off-label indication by median maximum tolerated dose and a description of any changes in individual medication doses.

To assess feasibility of the study protocol in terms of recruitment and refusal rates.

To assess feasibility of the study protocol in terms of rate of study completion.

To assess safety of metformin treatment in this off-label indication by the type, grade, and number of adverse events and serious adverse events including any suspected unexpected serious adverse reactions in the patients; drop-out rates; and a description of any changes in individual medication doses including median maximum tolerated dose.

To assess feasibility of the study protocol in terms of rate of adherence to protocol procedures (study medication and study procedures).

Change in variant allele frequency (ΔVAF) by next generation sequencing (NGS)

Change in patient-reported outcome measures (PROM), based on the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

Change in patient-reported outcome measures (PROM), based on the validated Short Form 36 Health Survey Questionnaire (SF-36).

Change in patient-reported outcome measures (PROM), based on the validated European Quality of Life Five Dimension questionnaire (EQ-5D).

Change in bone marrow adipose tissue (BMAT) content in bone marrow (BM) measured by MR spectroscopy

Change in bone mineral density (BMD) measured by DEXA scan measured in grams per cubic centimeter with resulting Z score.

Change in body composition measured by DEXA scan presented as whole body bone mass and soft tissue composition with ratios of lean mass, body fat, and bone mass.

Change in gut microbiota by 16S rRNA sequencing or whole genome sequencing of intestinal bacteria.

Change in small intestinal permeability by functional assessment by urine-lactulose/mannitol measurement and ion chromatography or by indirect assessment by qPCR and 16S rRNA sequencing of whole blood.

Change in DNA methylation and hydroxymethylation (5-mC and 5-hmC) patterns in hematopoietic cells by global 5-hmC/5-mC assessment and EPIC arrays.

Change in RNA expression in hematopoietic cells and BM adipocytes.

Change in protein profiles in hematopoietic cells and BM adipocytes by proteomics.

Rates of response and disease progression as according to the International Working Group (IWG) response criteria in myelodysplastic neoplasms.

Change in niche factors in bone marrow by ELISA.

Change in cytokine levels in peripheral blood and bone marrow plasma by ELISA.

Steno Diabetes Center Copenhagen

Zealand University Hospital

Van Andel Research Institute

Herlev Hospital

Technical University of Denmark

Region Hovedstadens Apotek

University of Copenhagen

Kirsten Grønbæk

Professor, MD, DMSc

Immune System Diseases

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lymphoproliferative Disorders

Myeloproliferative Disorders

Leukemia, Prolymphocytic

Primary Myelofibrosis

Leukemia, B-Cell

Immunoproliferative Disorders

Lymphatic Diseases

Leukemia, Biphenotypic, Acute

Chronic Disease

Disease Attributes

Myelodysplastic-Myeloproliferative Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Antirheumatic Agents

Anti-Infective Agents

Tacrolimus

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Melphalan

Mycophenolic Acid

Busulfan

Immunosuppressive Agents

Mesna

Antineoplastic Agents, Alkylating

Alkylating Agents

Calcineurin Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Patients Receive:

Patients receive:

Busulfan (≥ 9 mg/kg total dose) IV or PO on days -6 to -3 Fludarabine (150 mg/m2 total dose) IV on days -6 to -2

Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0.

Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.

First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Patients receive:

Fludarabine (90 mg/m2 total dose) IV on days -7 to -5 Total body irradiation (TBI) (1200 cGy total dose) on days -4 to -1

Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0.

Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.

First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Patients receive:

Fludarabine (150-180 mg/m2 total dose) IV on days -6 to -2 Busulfan (less than or equal to 8 mg/kg PO or 6.4 mg/kg IV) on days -5 and -4

Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0.

Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.

First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Patients receive:

Fludarabine (125-150 mg/m2 total dose) IV on days -7 to -3 Melphalan (100-140 mg/m2) IV on day -1

Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.

First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Patients receive:

Fludarabine (150mg/m2 total dose) IV on days -6 to -2 Cyclophosphamide (29-50mg/kg) IV on days -6 and -5 TBI (200cGy) on day -1

Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Patients receive a reduced dose of cyclophosphamide (25mg/kg per dose) on Day 3 and Day 4 post-transplant.

First 20 patients with a 4-6/8 mismatched unrelated donor will receive an alternate dose of post-transplant cyclophosphamide of 37.5 mg/kg on Days 3 and Day 4 post-transplant.

Given IV or PO pre-transplant as part of conditioning regimen

Given IV pre-transplant as part of conditioning regimen

Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0

PBSC Hematopoietic Stem Cell Transplantation (HSCT)

Cyclophosphamide (25mg/kg) is administered on Day 3 and Day 4 post-transplant as an IV infusion over 1-2 hours.

First 20 subjects with a 4-6/8 HLA mismatched unrelated donor will receive an intermediate dose of post-transplant cyclophosphamide of 37.5 mg/kg Day 3 and Day 4 post-transplant.

Post-Transplant Cyclophosphamide

Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post cyclophosphamide.

Tacrolimus is given at a dose of 0.05 mg/kg PO or an IV dose of 0.03 mg/kg of ideal body weight (IBW) starting on Day +5 post-transplant with taper recommended at Day + 90 and finished by Day +180.

Mycophenolate mofetil (MMF) is given at a dose of 15 mg/kg three times daily IV or PO from Day +5 to Day +35 post-transplant.

Mycophenolate Mofetil

Survey assessments will be administered to study participants pre transplant, at Day + 100, Day + 180, and Day +365 post transplant.

Patient Reported Outcomes

Given IV pre transplant as part of conditioning regimen

Administered pre-transplant as part of conditioning regimen

Total-body irradiation

Brandan Butler, MBA

OPTIMIZE Study Team

Monzr AlMalki, MD

Hemant Murthy, MD

Antonio M Jimenez Jimenez, MD

Farhad Khimani, MD

Mahasweta Gooptu, MD

Dipenkumar Modi, MD

Mark Juckett, MD

Ramzi Abboud, MD

Brian Shaffer, MD

Katarzyna Jamieson, MD

Rachel J Cook, M.D.

Shannon McCurdy, MD

Betul Oran, MD

Karen Ballen, M.D.

Karen Ballen, MD

Masumi Ueda Oshima, MD

Sameem Abedin, MD

Steven Devine, MD

Jeffery Auletta, MD

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 aims to answer are:

* Does a reduced dose of PTCy reduce the occurrence of infections in the first 100 days after transplant?
* Does a reduced dose of PTCy maintain the same level of protection against Graft Versus Host Disease (GvHD) as the standard dose of PTCy?

HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis

A Phase II Study of Reduced Dose Post Transplantation Cyclophosphamide as GvHD Prophylaxis in Adult Patients With Hematologic Malignancies Receiving HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Survival at 100 days without grades 2-3 infections (per BMT CTN grading criteria)

Defined as time interval between date of transplant and death from any cause

Defined as disease relapse or progression, or death by any cause

Defined as death and grades II-III infection (per BMT CTN criteria)

Defined as relapse or progression of underling disease (by 1 year), grade III-IV acute GvHD (by 6 months), chronic GvHD requiring systemic immune suppression (by 1 year), or death by any cause (by 1 year).

Defined as death without evidence of disease progression or recurrence

Defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/mm3 for three consecutive measurements on three different days

Defined as platelet count ≥20,000/mm\^3 or ≥50,000/mm\^3 with no platelet transfusions within seven days.

Primary graft failure is defined as no neutrophil recovery to ≥ 500 cells/mm3 by Day 28 post HCT.

Secondary graft failure is defined as as initial neutrophil count recovery followed by subsequent decline in absolute neutrophil counts \<500 cells/mm3, unresponsive to growth factor therapy, but cannot be explained by infection, disease relapse, or medications.

Defined as percent of donor chimerism via peripheral blood

Defined as cumulative incidence of grades II-IV acute GvHD

Defined as grades 2-3 infection as defined by BMT CTN grading criteria.

Defined as incidence of BK virus hemorrhagic cystitis per BMT CTN grading criteria

Defined as disease relapse or progression from Day 0 to 1-year post-HCT

To tabulate adverse events (AEs, experienced by recipients, defined as grade 3-5 unexpected and grade 5 expected AEs according to CTCAE v5

Defined and graded using the ASTCT grading criteria.

National Marrow Donor Program

Center for International Blood and Marrow Transplant Research

Neoplasm Metastasis

Micronutrients

Vitamins

Ascorbic Acid

Vitamin C

The intervention, specific to the study, is to take blood samples on patients with MDS at diagnosis. A quality of life questionnaire will also be used to monitor patients

The intervention, specific to the study, is to take blood samples on patients with MDS receiving treatment. A quality of life questionnaire will also be used to monitor patients

The intervention, specific to the study, is to take blood samples on patients healthy volunteers.

Samples

Questionnaire to assess the quality of life of cancer patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)	NCT00502112	Myelodysplastic...	lintuzumab lenalidomide	18 Years -	Seagen Inc.
Repurposing Metformin as a Leukemia-preventive Drug in CCUS and LR-MDS	NCT04741945	Preleukemia Myelodysplastic... Cytopenia Preleukemic Ane...	Metformin	18 Years -	Rigshospitalet, Denmark
HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis	NCT06001385	Acute Lymphobla... Acute Myeloid L... Acute Leukemia Myelodysplastic... Chronic Myeloid... Chronic Lymphoc... Myeloproliferat... Lymphoma Chronic Myelomo... Pro-Lymphocytic... Myelofibrosis	Busulfan Fludarabine PBSC Hematopoie... Post-Transplant... Mesna Tacrolimus Mycophenolate M... Patient Reporte... Melphalan Total-body irra... Cyclophosphamid...	18 Years -	Center for International Blood and Marrow Transplant Research
Plasmatic L-AScorbic Acid in MYelodyplastic Syndroms and Controls	NCT02809222	Myelodysplastic... Secondary Acute...	Samples Quality of life...	60 Years -	University Hospital, Tours
Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies	NCT00943592	Advanced Hemato... Leukemia Preleukemia	Clofarabine Melphalan Campath Stem Cell Trans...	18 Years - 75 Years	University of Chicago
Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies	NCT00943293	Preleukemia Myeloproliferat... Lymphoma Myeloma Graft Versus Ho...	Fludarabine Melphalan Campath	18 Years -	University of Chicago
A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia	NCT00637052	Advanced MDS Acute Myeloid L...	ARRY-520, KSP(E...	17 Years -	Pfizer
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide	NCT04904588	Acute Lymphobla... Acute Myelogeno... Mixed Phenotype... Acute Leukemia Myelodysplastic... Chronic Myeloge... Chronic Lymphoc... Lymphoma	Busulfan Busulfan Fludarabine Total-body irra... Cyclophosphamid... Melphalan PBSC Hematopoie... Bone Marrow Hem... Post-transplant... Mesna Tacrolimus Mycophenolate M... Patient-Reporte...	1 Year -	Center for International Blood and Marrow Transplant Research
Plasmatic L-AScorbic Acid in MYelodyplastic Syndroms and Controls	NCT02809222	Myelodysplastic... Secondary Acute...	Samples Quality of life...	60 Years -	University Hospital, Tours

Spots Global Cancer Trial Database for preleukemia

Every month we try and update this database with for preleukemia 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 preleukemia

Every month we try and update this database with for preleukemia 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 preleukemia 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.