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NCT ID: NCT02631993 Completed - AML Clinical Trials

Photochemotherapy and Graft-versus-leukemia in Acute-leukemia

Start date: October 2014
Phase: N/A
Study type: Observational

Cure of leukemia after hematopoietic stem cell transplantation (HSCT) is sustained by the anti-leukemic effect of the grafted cells (graft-versus-leukemia (GVL)). However, it is not known whether the tumor-immunity is affected by photochemotherapy (psoralene photosensitization and ultraviolet light radiation) administered to attenuate graft-versus host disease (GVHD). The present study aim to investigate what happens to the GVL after photochemotherapy of aGVHD in a predominantly retrospective setting with 10-years follow-up after HSCT

NCT ID: NCT02528435 Completed - Clinical trials for Juvenile Idiopathic Arthritis

Understanding Methotrexate Induced Gastrointestinal Intolerance in Juvenile Idiopathic Arthritis and Childhood Leukemia

Start date: December 2013
Phase:
Study type: Observational

Methotrexate is a cornerstone in the treatment of childhood leukemia. When given in high-dose as part of the initial phase of treatment, gastrointestinal toxicity is a known problem. However when children reach maintenance treatment with low-dose methotrexate this is not described as a significant challenge. Children with juvenile idiopathic arthritis are another patient group receiving low-dose methotrexate. Among these patients gastrointestinal intolerance is such a significant problem that treatment may be ceased. The aim of this project is to create a greater understanding of gastrointestinal intolerance associated to low-dose methotrexate treatment by investigating the differences between these two patient groups, investigating genetic and psychological factors.

NCT ID: NCT02227680 Completed - ALL Clinical Trials

Massage Therapy Versus Music Therapy Pilot Study

Start date: July 2014
Phase: N/A
Study type: Interventional

This project studies the feasibility of (1) implementing massage therapy and music therapy onto a busy medical inpatient unit at Boston Medical Center, and (2) evaluating massage therapy and music therapy's impact on patient satisfaction, patient outcomes, and cost. The investigators will conduct a randomized controlled trial comparing massage therapy, music therapy, and usual care to collect preliminary data on critical outcomes for patients (satisfaction, symptom control) and for the hospital (pain medication use and length of stay, both critical drivers of cost). The investigators anticipate using these preliminary data to apply for a future larger and longer adequately powered randomized controlled trial to definitively answer the following research questions: does implementation of an inpatient massage therapy and/or music therapy service (a) improve patient satisfaction; (b) reduce symptoms such as pain; and (c) lower health care costs through less pain medication and reduced length of stay?

NCT ID: NCT02133599 Completed - ALL Clinical Trials

Prediction of Excretion and Toxicity of High Dose Methotrexate in Children and Adolescents With ALL

Start date: July 24, 2014
Phase: N/A
Study type: Interventional

Each year approximately 2,900 children and adolescents less than 20 years old are diagnosed with acute lymphoblastic leukemia or acute lymphoblastic lymphoma in the United States. (For the purposes of this protocol, ALL will be used to refer to patients with either acute lymphoblastic leukemia or acute lymphoblastic lymphoma as patients are treated in the same manner.) High-dose methotrexate (HDMTX; 5 g/m2) remains an important component of standard treatment for most ALL patients. However, high plasma and intracellular MTX concentrations (defined as a MTX level of >1 µmol/L at 42 hours and > 0.40 µmol/L at 48 hours) can quickly lead to acute kidney, bone marrow, liver, skin, central nervous system, and gastrointestinal toxicities requiring extended hospitalization and delays in subsequent chemotherapy treatments. This study seeks to identify more sensitive markers of kidney injury that could serve as better predictors of delayed excretion and/or toxicity of HDMTX. This study is a pilot repeated-measures feasibility study. Hypothesis 1: Directly measured GFR (mGFR, a type of test to measure the filtering rate of kidneys) by iohexol clearance obtained prior to HDMTX will demonstrate greater sensitivity and specificity for prediction of delayed MTX excretion and/or toxicity in children and adolescents with ALL than serum creatinine (sCr) alone or sCr used for eGFR calculation. If this study proves that mGFR is a better predictor of delayed MTX excretion and/or toxicity, then another study will be developed in the future to determine if modifying the HDMTX dose or adjusting supportive care based on mGFR will prevent delayed clearance and toxicity without impacting patient survival. Hypothesis 2: Those participants prospectively demonstrating delayed MTX excretion or toxicity will exhibit elevation of kidney injury biomarkers less than 24 hours following initiation of HDMTX infusion compared to pre-chemotherapy measurements. These biomarkers will increase prior to a measurable sCr elevation.

NCT ID: NCT01593696 Completed - Leukemia Clinical Trials

Anti-CD19 White Blood Cells for Children and Young Adults With B Cell Leukemia or Lymphoma

Start date: June 29, 2012
Phase: Phase 1
Study type: Interventional

Background: - Although progress has been made in treating children with B-cell cancers such as leukemia or lymphoma, many children do not respond to the standard treatments. One possible treatment involves collecting white blood cells called T cells from the person with cancer and modifying the cells to attack the B-cell cancer. The cells can then be given back to the participant. This study will use T cells that have been modified to attack the cluster of differentiation 19 (CD19) protein, which is found on the surface of some B-cell cancers. Objectives: - To see if anti-CD19 modified white blood cells are a safe and effective treatment for children and young adults with advanced B-cell cancer. Eligibility: - Children and young adults between 1 and 30 years of age who have B-cell cancer (leukemia or lymphoma) that has not responded to standard treatments. - The leukemia or the lymphoma must have the CD19 protein. - There must be adequate organ function. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies or bone marrow biopsies may be performed depending on the type of cancer. - Participants will undergo a process where white blood cells are collected, called apheresis. These cells will be modified to contain the anti-CD19 gene. - Participants will have 3 days of chemotherapy to prepare their immune system to accept the modified cells. - Participants will receive an infusion of their own modified white blood cells. They will remain in the hospital until they have recovered from the treatment. - Participants will have frequent follow-up visits to monitor the outcome of the treatment. - If the participant benefits from the treatment, then he/she may have the option for another round of treatment.

NCT ID: NCT01319864 Completed - AML Clinical Trials

POETIC Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients

Start date: March 2011
Phase: Phase 1
Study type: Interventional

In this Phase I study, we will test the safety of the drug plerixafor (MOBOZIL) at different dose levels, used together with other anti-cancer drugs—cytarabine and etoposide. We want to find out what effects, good and /or bad, this combination of drugs has on leukemia. Plerixafor is a drug that blocks a receptor on the leukemia cell, which prevents it from staying in the bone marrow where it can be resistant to chemotherapy. Plerixafor is FDA approved for mobilizing stem cells from the bone marrow in preparation for an autologous stem cell transplant. Cytarabine and etoposide have been used as part of standard chemotherapy for ALL and AML. However, the use of plerixafor with cytarabine and etoposide in pediatric patients with relapsed or refractory ALL, AML and MDS is considered experimental.

NCT ID: NCT01204164 Completed - Multiple Myeloma Clinical Trials

Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological Malignancies

TG02-101
Start date: August 2010
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, dose escalation Phase 1 study.

NCT ID: NCT01012492 Completed - AML Clinical Trials

Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to determine the safety and tolerability when adding abatacept to acute Graft versus Host Disease in transplants for malignant diseases using unrelated donor bone marrow or peripheral blood stem cell grafts.

NCT ID: NCT00964873 Completed - Clinical trials for Acute Myeloid Leukemia

A Phase 1 Study of the HSP90 Inhibitor, STA-9090 in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia

Start date: August 2009
Phase: Phase 1
Study type: Interventional

An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML.

NCT ID: NCT00891592 Completed - Multiple Myeloma Clinical Trials

Umbilical Cord Blood Transplant for Hematological Malignancies

UCB
Start date: January 2009
Phase: Phase 1
Study type: Interventional

This protocol will enroll subjects with advanced hematologic malignancies who do not have a suitable related or unrelated donor to undergo a Stem Cell Transplant. In this study, subjects will undergo a Stem Cell Transplant using Cord Blood. Part of the cord blood will be used for the Stem Cell Transplant and part of the cord blood will be sent to a laboratory in order to grow the T cells (from the cord blood) and increase the activity of the cord blood T cells. The purpose of this part of the study is to see if it is safe to give study subjects activated T cells made from a small portion of their donor UCB unit immediately after the UCB transplant. Activated T cells have been used safely in stem cell transplantation studies in the past, but they have never been studied UCB transplantation.