Decitabine and Vaccine Therapy for Patients With Relapsed AML Following Allogeneic Stem Cell Transplantation...
Acute Myelogenous LeukemiaPatients with Acute Myelogenous Leukemia (AML) who relapse after an allogeneic stem cell transplant cell receive decitabine to up regulate cancer antigen expression, followed by a donor lymphocyte infusion and an autologous dendritic cell (DC). Vaccine Dendritic cells are pulsed with overlapping peptides derived from MAGE-A1, MAGE-A3, and NY-ESO-1.
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia
Chronic Myeloid LeukemiaDonors with CM will be solicited from a waiting list of patients awaiting BMT from the waiting list of MUD searches. Maximally matched donor will be searched for each eligible CML patient with a goal in mind to find other patients with CML that share both class I and class II determinants. Sharing of one class I II will be considered eligible for participation in the study. Peripheral blood and PBMC from the donors will be isolated, washed and irradiated. The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals for a total of 6 injections.
CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies
Hematologic DiseasesHematologic Malignancy4 moreThis is a Phase II trial testing disease-specific myeloablative conditioning regimens for preparatory cytoreduction of patients receiving allogeneic HLA-compatible related or unrelated transplants of GCSF-mobilized peripheral blood stem cells (PBSC) depleted of T-cells by positive selection of CD34+ progenitor cells using the CliniMACS system. The CliniMACS Fractionation system is a method that positively selects CD34+ progenitor cells from PBSC by immunoadsorption of cells binding on anti CD34 monoclonal antibody to paramagnetic beads, which can then be isolated by passage through a magnetized column and released by agitation of beads. Two conditioning regimens have been used successfully with an alternative similar system, isolex, which is no longer being manufactured.
Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults:...
Acute Myeloid LeukemiaGenetic Predisposition to DiseasePediatric acute myeloid leukemias are disease with poor prognosis (overall survival of 60-75%) and high relapse rate of 35-45% require further understanding of the underlying biological mechanisms. The main objective of this study is to establish a biological collection to evaluate the genomic profiling of leukemic cells from primary blasts at diagnosis and/or relapse to improve identification of the main genetic hits involved in resistance and could predict a high risk of relapse. Other objectives include the study of bone marrow mesenchymal stem cells and ex vivo drug testing.
StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies
Acute Myeloid LeukemiaAcute Lymphocytic Leukemia2 moreThis is an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm.
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk...
Recurrent Adult Acute Myeloid LeukemiaSecondary Acute Myeloid Leukemia1 moreThis pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone hydrochloride, etoposide, and cytarabine [MEC]) in patients with acute myeloid leukemia (AML) that is likely to come back or spread (high-risk). Sirolimus inhibits or blocks the pathway that causes cancer cells to grow. Adding sirolimus to standard chemotherapy may help improve patient response. Studying samples of bone marrow from patients treated with sirolimus in the laboratory may help doctors learn whether sirolimus reverses or turns off that pathway and whether changes in biomarker levels can predict how well patients will respond to treatment.
Impact of a Pharmaceutical Care Model in the Management of Chronic Myeloid Leukemia Patients
LeukemiaMyelogenous3 moreOwing to effective treatment with tyrosine kinase inhibitors (TKIs), chronic myeloid leukemia (CML) has become a chronic disease with a rising prevalence globally. Although the possibility of stopping TKI therapy in CML patients who have achieved deep molecular responses is a topic of active debate and investigation, life-long treatment remains the current standard of care. It has been estimated that 3% to 56% of CML patients are not adherent to their prescribed TKI therapy. Poor adherence to TKIs could compromise the control of CML, and contributes to poorer survival. CML patients on long-term TKI therapy are prone to developing certain medication-related issues such as adverse reactions and drug interactions.Occurrence of adverse reactions even at low grades, has been shown to impact CML patient's health-related quality of life (HRQoL) and adherence to treatment. However, there is no prospective high quality evidence showing adherence to TKIs and the associated clinical outcomes can be improved in CML patients. Therefore, the investigators hypothesize that medication management intervention by pharmacist might improve adherence to TKIs, and translate into better disease response and HRQoL in CML patients, when compared to control arm who receive standard pharmacy service.
Stem Cell Monitoring for CML Patients Undergoing Nilotinib Therapy
Chronic Myeloid LeukemiaThe study is an open-label phase 2 clinical and translational trial designed to evaluate the effects of nilotinib on the leukemic stem cell population in subjects with newly diagnosed chronic phase chronic myeloid leukemia (Ph+ CML in CP). Nilotinib is FDA-approved to treat subjects with Ph+ CML in CP. Subjects on study will be monitored according to accepted National Cancer Comprehensive Network [NCCN] clinical guidelines for 24 months. After 24 months, if continued therapy is needed subjects will be transitioned to commercial supply of study drug.
Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid...
Acute Myeloid LeukemiaNeutropenia1 moreThe purpose of the study is to explore the safety and efficacy of CLT-008 as an extra supportive care measure after induction chemotherapy for patients with acute myeloid leukemia (AML).
Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease...
Multiple MyelomaLymphoma5 moreBackground: Family caregivers are of great importance to patients undergoing treatment for cancer, but at the same time, caregivers themselves are in great risk of distress and high symptom burden which affects their quality of life and ability to support the patients. Within hematology the context of treatment from hospital to home has changed in the past years placing more responsibilities on caregivers. Finding new ways to support caregivers within the health care context is important. Psychosocial interventions can enhance emotional well-being, and peer to peer support model has been found to be effective for patients coping with cancer. There is a lack of knowledge and evidence of the feasibility and effects of a peer-to-peer support in caregivers within hematology. Aims: The study aim to examine the feasibility and safety of Family Caregiver Ambassador Support in caregivers of newly diagnosed patients with hematological disease, and to examine if it has an effects on symptoms and psychological wellbeing in both family caregivers and ambassadors. It is hypothesized that the family caregiver peer to peer support model will reduce symptoms of burden, reduce concerns and improve emotional and social well-being in family caregivers. Design and methods: The study is a one arm feasibility intervention trial with family caregivers (n=30) and family caregiver ambassadors (N=20). Family Caregivers will be recruited at the Department of Hematology, Rigshospitalet. Family Caregivers will be partnered with a family caregiver ambassador. The intervention will be carried out in a 12-week period and consist of telephone and/or e-mail contact and face to face meetings with one follow-up at three months. Both caregiver and ambassador data will be collected at baseline, post intervention and follow-up 3 months. Implication: The study has the potential to be a new model of care incorporated in the clinical setting to strengthen the support system for caregivers and may likely be tailored to other cancer groups and caregivers.