Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Immunomodulating Agents

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Participants will take two 5 mg capsules of lenalidomide per day for 21 days followed by 7 days of rest. This 28 day period is considered 1 cycle. Participants will receive 4 treatment cycles with 28 days in each cycle. Those participants showing a clinical response after 4 cycles of treatment may continue to receive lenalidomide as a single agent for additional cycles at the treating Physicians discretion. During each 28 day cycle participants will also receive GM.CD40L bystander vaccination injections in 2-week intervals on days 8 and 22 for a total of 8 immunizations during the 4 cycle treatment period.

Patients will take 10 mg capsules of lenalidomide per day for 21 days followed by 7 days of rest. This 28 day period is considered 1 cycle. Patients will receive 4 treatment cycles with 28 days in each cycle.

lenalidomide

In addition to lenalidomide, during each 28 day cycle patients will also receive GM.CD40L bystander vaccination injections in 2-week intervals on days 8 and 22 for a total of 8 immunizations during the 4 cycle treatment period.

bystander vaccine

Javier Pinilla, M.D., Ph.D.

The purpose of this study is to find out the maximum tolerated dose (MTD) of the combined therapy of lenalidomide (Revlimid®) and Granulocyte/macrophage colony stimulating factor and CD40 Ligand expressed in the K562 cell line (GM.CD40L) bystander vaccine. This research is also being done to see how well the combination of these drugs works to fight myelodysplastic syndrome (MDS).

Fixed dose of lenalidomide at 10 mg/day, Days 1- 21 of 28 days of treatment cycle, and 4 dose escalations of GM.CD40L vaccine: 10 X 10\^6 GM.CDL cells per vaccination; 30 X 10\^6 GM.CDL cells per vaccination; 60 X 10\^6 GM.CDL cells per vaccination; 120 X 10\^6 GM.CDL cells per vaccination; Vaccination at 2-week intervals, on days 8 and 22, for a total of four 28-day cycles.

Immunotherapy Using Lenalidomide + Bystander Vaccine in High Risk Myelodysplastic Syndrome (MDS)

A Phase I Pilot Study of Immunotherapy Using Lenalidomide Plus "Bystander" Vaccine in Patients With High-Risk Myelodysplastic Syndrome (MDS)

Determination of MTD of GM.CD40L bystander vaccine with lenalidomide in high-risk MDS patients.

Determination of toxicities associated with combination of GM.CD40L bystander vaccine with lenalidomide in high-risk MDS patients.

Augmentation of specific T cell immunological functions; T cell proliferation and Interferon-γ production, delayed type hypersensitivity (DTH) sensitivity by lenalidomide.

Reduction of bone marrow myeloblast from baseline to post treatment with lenalidomide and GM.CD40L bystander vaccine.

Improvement of hemoglobin and/or RBC transfusion independence after combined immunotherapy treatment.

Resolution of karyotypic changes after combined treatment.

Augmentation of other T cell parameters after the combined treatment.

Determination of response duration evaluated by Wilms Tumor 1 (WT1) expression and clinical outcomes. Clinical response will be assessed using International Working Group (IWG) criteria.

Celgene

H. Lee Moffitt Cancer Center and Research Institute

Azacitidine

Antimetabolites

Enzyme Inhibitors

5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).

Once enrolled, the patients will receive pre-transplant 5-azacitidine (Vidaza) 75 mg/M\^2/day subcutaneously for 5-7 days every 28 days). Adjustments in dose and timing may occur based on clinical and hematological parameters.

5-azacitidine

Patients will receive transplantation if there is either a suitable sibling or an unrelated donor.

* Response will be evaluated by bone marrow biopsy after 4 cycles of 5-azacitidine or prior to HCT whichever comes first. Due to the very high risk of progression to AML or death in this patient population, the HCT will be done as soon as possible.
* The patients may have additional cycles of 5-azacitidine per standard hematology practice until scheduled for transplant or until progression of disease.
* All patients will be followed until time to progression of MDS, AML or death or a maximum of 1 year. For patients that are transplanted, follow up will be to one year post-transplant.

Allogeneic Hematopoietic Cell Transplantation (HCT)

Teresa Field, M.D., Ph.D.

Janelle Perkins, Pharm.D.

The purpose of this study is to find out if treating people who have high-risk myelodysplastic syndrome (MDS) with 5-Azacitidine (Vidaza) prior to their allogeneic hematopoietic cell transplant (HCT) is helpful in preventing their myelodysplastic syndrome from coming back.

In previous research, 5-Azacitidine appeared to help the bone marrow of a patient with MDS begin to function more normally. This means bone marrow cells can grow and do their work the way they were meant to. 5-Azacitidine is approved by the Food and Drug Administration (FDA) for the treatment of MDS. The effect of 5-Azacitidine in patients receiving hematopoietic cell transplants have not been studied.

RESEARCH PLAN

* This will be a single-center prospective trial
* Patients with high risk MDS that are potentially eligible for HCT will be enrolled.
* A donor search will be initiated, and 5-Azacitidine will be given per standard practice.
* 5-Azacitidine dose is 75 mg/M\^2/day subcutaneously by standard practice (generally this is 7 days per monthly cycle, but alterations occur depending on clinical and laboratory parameters).
* Patients where a suitable donor is not found can continue with 5-Azacitidine per standard treatment. These patients will be followed until progression of MDS to acute myelogenous leukemia (AML) or death, for up to one year.
* If a suitable donor is obtained, the patient will proceed to HCT. The HCT conditioning regimen will be dictated by the Blood and Marrow Transplant (BMT) physician. While waiting HCT, additional cycles 5-Azacitidine may be given. Pre-HCT conditioning regimen therapy will begin no more than 8 weeks and no less than 4 weeks after the last administration of 5-Azacitidine.
* As the number of cycles of 5-Azacitidine is not standardized and the retrospective review of our patients noted above indicated a benefit to ANY exposure to 5-Azacitidine, the actual number of cycles of 5-Azacitidine delivered will not be specified. In addition, as high risk MDS patients have an average time to death of 0.4 years, any delay to HCT once it is available is to be avoided.
* A bone marrow biopsy will be performed to reassess disease response to therapy after the last cycle of 5-Azacitidine before transplant, or after the fourth cycle of 5-Azacitidine, whichever comes first. Note that both the biopsy and the timing of the biopsy is a standard evaluation procedure.
* Donor progenitor cell collection will be prescribed by the BMT Attending Physician.

HCT

* The patient will undergo HCT designated per attending BMT physician.
* Supportive care will be based on institutional guidelines, Stem cell collections, processing and laboratory studies

Stem cell collections, processing and laboratory studies

* Graft assessment, processing, and characterization will be done as per institutional guidelines
* Chimerism testing will be obtained to document post-transplant engraftment, per standard practice.

Pre-Transplant 5-Azacitidine In Patients With High-Risk Myelodysplastic Syndrome Who Are Candidates For Allogeneic Hematopoietic Cell Transplant

A Pilot Study Of Pre-Transplant 5-Azacitidine (Vidaza) In Patients With High-Risk Myelodysplastic Syndrome (MDS) Who Are Candidates For Allogeneic Hematopoietic Cell Transplantation

Relapse-free survival one year after allogeneic HCT in MDS patients receiving at least one complete cycle of 5-azacitidine (Vidaza) in the pre-transplantation setting. Relapsed disease: if with complete remission (CR) - greater than 5% blasts in bone marrow; if with partial response (PR) - greater than 30% increase in blasts in the marrow; if with stable disease (SD) - return to pretreatment peripheral blood levels and transfusion requirements due to disease.

Pre-allogeneic HCT responses to 5-azacitidine (Vidaza), based on the International Working Group criteria: Complete Remission (CR); Partial Response (PR); Stable Disease (SD). Point estimates and 95% confidence intervals were calculated for the response rate to 5-azacitidine, evaluated at marrow evaluation after 4 cycles of 5-azacitidine or prior to HCT whichever came first. CR: Bone marrow with 5% myeloblasts and normal maturation of all cell lines. PR: All CR criteria if abnormal before treatment except bone marrow blasts decreased by 50% over pretreatment but still \> 5%. SD: Failure to attain CR, PR, relapsed (or progressive) disease.

Proportion of patients enrolled who subsequently proceeded to allogeneic HCT.

Overall survival for all participants at one year after first dose of 5-azacitidine (Vidaza). Overall survival was calculated by the method of Kaplan-Meier with standard errors computed using Greenwood's formula.

Celgene Corporation

This was a standard of care study for Myelodysplastic Syndrome patients, with 5-Azacitidine prior to standard transplant.

Combined Therapy

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

21 of 25 participants proceeded to allogeneic HCT and were evaluated for most measures.

Limitation: Small single center pilot study to show the use of pre-treatment 5-Azacitidine and successfully proceeding to transplant.

Participants who proceeded to allogeneic HCT

Percentage of Participants With Relapse-free Survival (RFS)

Partial Response

Complete Remission

Stable Disease

Progressive Disease

Overall Response Rate (ORR)

Percentage of Participants Who Proceed to Hematopoietic Cell Transplantation (HCT)

Percentage of Participants With Overall Survival (OS)

Overall Study

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Azacitidine 50 mg/m\^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles.

Azacitidine given subcutaneously as outlined in treatment arm.

Jeffrey E. Lancet, M.D.

The purpose of this study is to find out if patients older than 60, with acute myeloid leukemia, who are in complete remission following initial chemotherapy, will live longer and have a lower rate of leukemia relapse when treated with azacitidine.

Patient activity will encompass approximately 48 months: an approximate 24 month enrollment period, followed by 6 to 12 months of patient treatment. Patients will be followed for 1 year following completion of study drug treatment. During follow-up, bone marrow biopsies to confirm disease status should be obtained if peripheral blood blasts are present or if there is development of unexpected blood abnormalities to warrant suspicion of relapse, or at a minimum of every 6 months.

Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy

A Multicenter, Phase 2 Study of Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia in Complete Remission After Induction Chemotherapy

The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with \>5% blasts or the presence of Auer rods.

The secondary efficacy variable is overall survival measured as time to death, which is the time from remission until death from any cause.

Safety and tolerability of treatment as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Adverse event observation from after study drug administration on cycle 1 /day 1, through 28 days following the last dose of azacitidine.

Azacitidine 50 mg/m\^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.

Azacitidine Treatment

Only five participants completed study and defined follow-up period and one participant remained on follow-up at time of analysis.

Jeffrey Lancet, M.D.

Rate of Disease Free Survival at One Year

Overall Survival (OS)

Number of Participants With Adverse Events

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Wilms Tumor

Wilms' Tumor

Anti-Infective Agents

Molgramostim

Sargramostim

Interferons

Monatide (IMS 3015)

Adjuvants, Immunologic

Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.

Immune responses were to be evaluated at weeks 6 and 12 via delayed-type hypersensitivity, CD4 T cell proliferation, CD4 and CD8 T cell interferon release, as well as by bone marrow cytogenetics including polymerase chain reaction (PCR) to look for molecular evidence of disease. Patients who had an immunologic response and had not had disease progression could continue with up to 6 more vaccinations administered approximately every month. In that case, patients were to be reevaluated with bone marrows/immunologic studies after the 9th and 12th vaccination. In addition, patients would undergo evaluations for residual disease including immunohistochemistry and/or quantitative polymerase chain reaction (RQ-PCR) for WT-1 expression (on selected patients), and multiparameter flow cytometry (AML/ MDS).

WT-1

The WT-1 vaccine is given with another substance, called Montanide, which clumps the WT-1 vaccine and thereby improves the immune response.

Montanide

GM-CSF was administered at a dose 70 mcg (140ul) as a subcutaneous injection at the site of vaccination on day -2 and day 0.

Sargramostim (GM-CSF)

The purpose of this study is to determine whether the WT-1 vaccine causes an immune response and is safe. The WT-1 vaccine is made up of protein pieces that the patient's immune system can recognize as abnormal.

Design:

This will be a pilot trial evaluating the safety and immunogenicity of the WT-1 peptide vaccine in patients with hematologic malignancies. Ten patients with acute myelogenous leukemia (AML) or advanced myelodysplastic syndrome (MDS), will be enrolled. Patients will be vaccinated with a preparation of WT-1-derived native and synthetic peptides plus immunologic adjuvant Montanide ISA 51 VG (Seppic Pharmaceuticals, Fairfield, NJ) and Sargramostim (GM-CSF). One dose level will be tested.

Patients will receive 6 injections of the WT-1 vaccine. Doses will be given every 2 weeks. Each vaccine is given at a different location under the skin in the arm or leg. Patients will be monitored for 30 minutes after vaccination.

WT-1 vaccine is given with another substance, Montanide, which clumps the WT-1 vaccine and improves the immune response. Patients will also receive an injection of Sargramostim (GM-CSF) 2 days before each vaccination and again on the day of the WT-1 injection at the same spot. Sargramostim (GM-CSF) stimulates the body's white blood cells to boost the immune response. Patients may be taught to do the Sargramostim (GM-CSF) injection themselves in which case patients will be given a log sheet to record the injection time and location. If not, they will need to come for an additional 24 study visits.

To monitor their health while receiving the vaccine, patients will need the following tests and procedures as a part of regular cancer care.

* History and physical examination every 2 weeks
* Complete blood count (CBC) and comprehensive panel every 2 weeks
* Bone marrow aspirate at week 14 for patients with acute myelogenous leukemia or myelodysplastic syndrome.

Patients will need these tests and procedures to see whether the vaccine is causing an immune response:

* A skin test will be performed before patients start the study and again in the 8th and 14th weeks in which a small amount of the vaccine will be placed under the skin. Two days later, the site will be checked to see whether a bump or swelling has formed. Another substance which typically does cause a mild reaction (mumps) will also be placed under the skin to measure whether they have a normal immune reaction.
* We will take about 7 tablespoons of blood to measure their immune response. About 1 tablespoon of blood will be taken to measure the levels of WT-1 in their blood. Blood samples will be taken prior to receiving the first vaccination and prior to receiving the vaccination at weeks 6 and 12.

If the vaccine causes the patient to have an immune response, and their cancer does not grow, they may continue to receive the WT-1 vaccinations monthly for 6 more months. If this occurs, the patient will have a computed tomography (CT) scan or bone marrow test and immunology blood tests 2 weeks after the 9th and 12th vaccinations.

Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms

Toxicities were tabulated according to the NCI Common Toxicity (version 3.0) by grade and category. If more than one patient developed ≥ grade 3 non-hematologic toxicity or grade 4 hematologic toxicity, the study accrual was to be suspended immediately for a careful toxicity data evaluation. Depending upon the findings of such safety/toxicity data assessment and consultation with the supporting pharmaceutical company, the principal investigator of this trial would have the option of terminating this trial permanently, amending the study protocol, or resuming the patient accrual.

Immune Response: Immune reactivity was measured for all participants. Immune response was measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT and/or multiparameter intracellular staining by flow cytometry were performed as well.

ELISPOT Assay: CD4+ immune response, CD4+ and CD8+ response. The samples of participants' blood obtained at baseline and week 12 were tested for CD4 T cell proliferation, CD4 and CD8 T cell interferon release.

Tetramer Analysis of WT1-specific Immune responses: subtle WT1 T cell expansion, positive by ELISPOT and T cell expansion.

Delayed-type Hypersensitivity (DTH): measurable DTH response without overlap with ELISPOT or tetramer responders).

Overall: any form of immune response.

Innovive Pharmaceuticals

Participants received 6 bi-weekly vaccinations over 10 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy Using Lenalidomide + Bystander Vaccine in High Risk Myelodysplastic Syndrome (MDS)	NCT00840931	Leukemia	lenalidomide bystander vacci...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Pre-Transplant 5-Azacitidine In Patients With High-Risk Myelodysplastic Syndrome Who Are Candidates For Allogeneic Hematopoietic Cell Transplant	NCT00660400	Leukemia	5-azacitidine Allogeneic Hema...	18 Years - 68 Years	H. Lee Moffitt Cancer Center and Research Institute
Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy	NCT00387647	Leukemia	Azacitidine	60 Years -	H. Lee Moffitt Cancer Center and Research Institute
Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms	NCT00665002	Leukemia	WT-1 Montanide Sargramostim (G...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for monocytic

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

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