Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Antirheumatic Agents

Etoposide

Cytarabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Rituximab

Vincristine

Etoposide phosphate

rituximab 375 mg/m2 day 1 cyclophosphamide 750 mg/m2 day 1 doxorubicin 50 mg/m2 day 1 vincristine 1.4 mg/m2 day 1 etoposide 100mg/m2 days 1,2,3 Prednison 100 mg days 1,2,3,4,5 cycle repeated six times every two weeks followed by HD-AraC 3g/m2x4 and HD-mtx 3 g/m2 HD-AraC 3g/m2x4 times every 12 h

R-CHOEP14x6+HD-AraC+HD-Mtx

Harald Holte, MD, PhD

The purpose is to test whether dose densified chemoimmunotherapy followed by central nervous system (CNS) prophylaxis for young high risk diffuse large B-cell lymphoma (DLBCL) patients is feasible and could improve time to treatment failure and reduce the risk of CNS relapses. Six courses of rituximab-cyclophosphamide-doxorubicin-etoposide-vincristine-prednison (R-CHOEP) given in two weeks intervals with the support of G-CSF is followed by one course of high dose methotrexate (HD-MTX) and high dose cytarabine (HD-Ara-C). The results will be compared to a historical Nordic study.

Pathology:

Patients may be included on the bases of the histological diagnosis of the local pathologist. The specimen will be reviewed by a central pathologist in each country

Treatment:

All patients receive CHOEP-14 with rituximab x 6 with the support of G-CSF followed by high dose cytarabine i.v. and high dose methotrexate i.v.Intrathecal (i.t.) CNS prophylaxis in combination with chemotherapy is not to be given, but i.t. methotrexate may be given once after initial liquid sampling. Radiotherapy will be given at the discretion of the individual centres.

Investigations before, during and after treatment:

The disease status will be assessed prior to treatment start, after 3 cycles of CHOEP + rituximab and after completion of the treatment schedule. Positron Emission Tomography (PET) using F18 deoxyglucose may be performed after fulfillment of treatment. Persistent, suspected lymphoma tissue should whenever possible be confirmed with a biopsy, otherwise the patient will be regarded as PR and second line therapy will be considered (see schematic outline).

Clinical and radiological (CT) assessment are performed at pretreatment and subsequently on sites initially involved, and bone marrow biopsy if initially involved

* After the 3rd course
* After the last course (within one month) of chemotherapy (biopsy if indicated)
* After radiotherapy (for patient given radiotherapy as part of the primary treatment)

Clinical follow-up:

* 4x per year during the first and second year of follow-up
* 2x per year during the third, fourth and fifth year of follow-up

Radiological investigations at follow up:

-CT after 6, 12 and 24 months of sites initially involved. CT abdomen in all cases after 12 and 24 months. X-ray of the thorax (if CT thorax is performed) after 6, 12 and 24 months

Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)

CHOEP-14 + Rituximab With CNS Prophylaxis in Patients Less Than 65 Years With Diffuse Large B-Cell Lymphoma/Follicular Lymphoma Grade III, Stage II-IV With Risk Factors (Age Adjusted IPI) ≥ 2. A Phase II Study

Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as 1 day.

Grade 2-4 hematological and non-hematological adverse events according to the WHO Common Toxicity Criteria as specified in the protocol

Number of patients with complete and partial responses, stable or progressive disease after 3 courses and the end of treatment period

Time from registration to the date of disease progression. Otherwise, the patients are censored at the last date of follow up. Patients still alive in a complete response or lost to follow-up are censored at the last date they were known to be alive. Patients who die due to causes other than lymphoma are censored at the date of death

Time from the registration date to the date of death. Patients still alive or lost to follow-up are censored at the last date they were known to be alive.

Amgen

Nordic Lymphoma Group

Leukemia

Hematologic Diseases

Acute Graft Versus Host Disease

Dermatologic Agents

Fludarabine

Fludarabine phosphate

Cyclosporine

Cyclosporins

Mycophenolic Acid

Busulfan

Antilymphocyte Serum

Transplantation of unrelated cord blood units is done at least 24 hours after last chemotherapy and carried out during the same day. The unit presenting the best degree of HLA compatibility with the patient will be transfused in first. If the 2 units have the same degree of HLA compatibility with the recipient, the unit with the higher cell dose will be transfused in first. A 2 hours time interval between the 2 transfusions will be respected.

Transplantation of a single unrelated cord blood unit at least 24 hours after last chemotherapy

Myeloablative conditioning regimen includes, according to the patient age, either total body irradiation, fludarabine and cyclophosphamide with a GvHD prophylaxis based on cyclosporine A and mycophenolate, or the association busulfan, cyclophosphamide and anti-thymocyte globulin with GvHD prophylaxis being cyclosporine A and steroids.

Transplantation of unrelated cord blood unit(s)

Gerard MICHEL

Unrelated cord blood transplantation (UCBT) has been used for several years when there is no HLA identical sibling or unrelated donor.Since the recent publication of encouraging results after transplantation of two UCB units, the number of these double-transplantations increases in a very significant way.However, there is currently no prospective study comparing in a reliable way the double-transplantation to single-transplantation results.The investigators propose a prospective and randomized study comparing the results of single versus double unit UCBT in children and young adults (\< 35 yrs) with acute leukemia in remission. This is an open, multicenter study carried out in the allogeneic transplant centers from the French society for hematopoietic stem cell transplantation and cell therapy. The primary objective is to compare the incidence of transplantation failure in the two treatment arms. Transplantation failure, the primary endpoint of the study, is defined by the occurrence of one of the following events : transplant-related death, second allogeneic transplantation or autologous backup infusion for primary engraftment failure, autologous recovery. The financial impact of these double-transplantations being to date unknown, the project also includes a cost-effectiveness study, the effectiveness criterion being a decrease in transplantation failure incidence. The secondary clinical endpoints are: overall survival and disease-free survival, relapse incidence, transplant-related mortality, incidence of severe infections and GvHD. The secondary biological endpoints are: hematological and immunological recovery, post transplant chimerism.

Background and rationale:

Unrelated cord blood transplantation (UCBT) has been used for several years when there is no HLA identical sibling or unrelated donor. During the year 2007, 218 of the 783 unrelated hematopoietic stem cell transplantation (28%) carried out in France were UCBT. This proportion is 37% in children (58/157). Clinical outcome after UCBT strongly depends on the transplant cell dose. Since the recent publication of encouraging results after transplantation of two UCB units, the number of these double-transplantations increases in a very significant way. Thus 121/218 UCBT performed in France during 2007 were double-transplantations (55%) whereas this proportion was 81/180 (45%) in 2006, 30/144 (21%) in 2005, 5/77 (6%) in 2004 and 0/44 in 2003. However, there is currently no prospective study comparing in a reliable way the double-transplantation to single-transplantation results.

Study design:

The investigators propose a prospective and randomized study comparing the results of single versus double unit UCBT in children and young adults (\< 35 yrs) with acute leukemia in remission. This is an open, multicenter study carried out in the allogeneic transplant centers from the French society for hematopoietic stem cell transplantation and cell therapy (Société Française de Greffe de Moelle et de Thérapie Cellulaire, SFGM-TC).

Objectives:

The primary objective is to compare the incidence of transplantation failure in the two treatment arms. Transplantation failure, the primary endpoint of the study, is defined by the occurrence of one of the following events : transplant-related death, second allogeneic transplantation or autologous backup infusion for primary engraftment failure, autologous recovery. The financial impact of these double-transplantations being to date unknown, the project also includes a cost-effectiveness study, the effectiveness criterion being a decrease in transplantation failure incidence. The secondary clinical endpoints are: overall survival and disease-free survival, relapse incidence, transplant-related mortality, incidence of severe infections and GvHD. The secondary biological endpoints are: hematological and immunological recovery, post transplant chimerism.

Methods:

Transplantation methods: Myeloablative conditioning regimen includes, according to the patient age, either total body irradiation, fludarabine and cyclophosphamide with a GvHD prophylaxis based on cyclosporine A and mycophenolate, or the association busulfan, cyclophosphamide and anti-thymocyte globulin with GvHD prophylaxis being cyclosporine A and steroids.

Statistical methods: The experimental schedule is based on a multiple testing procedure, using the method described by O' Brien and Fleming. This offers the possibility of stopping the trial before the end of inclusions if a significant difference between the two arms occurs. In this trial, two sequential analyses are planned: an interim analysis at 18 months and a final analysis at 36 months. Probabilities of survival and DFS are estimated according to the Kaplan-Meier method. In the presence of one or several competitive risks, the cumulative incidence of an event is estimated according to the method of Gray. Thus, relapse is a competing risk for transplantation failure in the study primary endpoint evaluation. Comparisons between the two treatment arms are carried out by the Log rank test for Kaplan-Meier estimates and by the Gray's test for the cumulated incidences. The intent to treat analysis (according to the random allocation) will be preferred to a per-protocol analysis which will be an additional analysis. An independent committee will be made up in order to control the decisions of study continuation or stopping at time of the interim analysis.

Sample calculation, study feasibility and duration:

In the setting of a sequential trial including one interim analysis, with a cumulated incidence of transplantation failure hypothesis being 40% in the single-transplantation and 20% in the double-transplantation arm (alpha risk, 5%, power, 80%, 5% non evaluable patients), the estimate of sample size is 99 by group, i.e. a total of 198. Taking into account the UCBT activity in France (data from the French biomedicine agency), the enrolment phase of the study is planned to last 30 months. Minimum post-transplant follow-up duration being 6 months, duration of the study is 3 years.

A Study Comparing Single Versus Double Umbilical Cord Blood Transplantation in the Young With Acute Leukemia Remission

A Prospective, Multicenter Randomized Study Comparing Single Versus Double Umbilical Cord Blood Transplantation in Children and Young Adults (<35 Years) With Acute Leukemia Remission

Assistance Publique Hopitaux De Marseille

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Denosumab

Martine J Piccart, Prof.

Christos Sotiriou, MD

Hatem Azim, MD

Sherene Loi, MD,PhD

This is a prospective, single arm phase IIa trial in which patients with early breast cancer will receive pre-operatively two doses of denosumab 120mg subcutaneously one week apart (maximum 12 days) followed by surgery. Tumor, normal breast tissue and blood samples will be collected at baseline and at surgery. Post-operative treatment will be at the discretion of the investigator.

Primary objective: to determine if a short course of RANKL inhibition with denosumab can induce a decrease in tumor proliferation rates as determined by Ki67 immunohistochemistry (IHC) in newly diagnosed, early stage breast cancer in pre-menopausal women.

Secondary objectives:

* To determine the number of absolute Ki67 responders after a short course of denosumab (defined as \<2.7% IHC staining in the post treatment tumor biopsy).
* To determine the effects of a short course of denosumab on serum C-terminal telopeptide levels (CTX).
* To determine the effects of a short course of denosumab on RANK/RANKL gene expression and signaling as assessed by immunohistochemistry (IHC) and RNA sequencing in the tumor.
* To determine the effect of a short course of denosumab on tumor apoptosis rates using IHC
* To determine the effect of a short course of denosumab on modulating the immature mammary epithelial cell populations in the tumor.
* To determine the effect of a short course of denosumab on estrogen signaling pathways in the tumor.
* To determine the effect of a short course of denosumab on various immune
* To determine effect of safety profile of denosumab

A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer

A Pre-Operative Window Study Evaluating Denosumab, a RANKligand (RANKL) Inhibitor and Its Biological Effects in Young Premenopausal Women Diagnosed With Early Breast Cancer

Assessed by immunohistochemistry (IHC) from

KI 67 responders will be defined as below 2.7% Ki67 IHC staining in the post treatment tumor biopsy

Assessed by immunohistochemistry (IHC) and RNA sequencing profile in the tumor

Change in tumor proliferation rates using gene expression (single genes and gene modules, i.e. AURKA, Ki-67) and proliferation-related gene modules, i.e. GGI) in the tumor from baseline to prior to surgery

Change in tumor apoptosis rates as measured using TUNEL and caspase-3 IHC from baseline to prior to surgery

Change in expression levels from genes corresponding to immature mammary epithelial cell populations (MaSCs and luminal progenitors developed by Lim et al; Nature 2009), and in IHC expression of ALDH1, a stem cell marker in the tumor

Change in expression levels from single genes related to the estrogen pathways (i.e. ESR1, PgR, BCL2 using both gene expression and IHC) and estrogen-related gene expression modules (i.e. ESR module) in the tumor

Change in expression levels from single genes related to immune pathways using both gene expression and IHC, and in immune-related gene expression modules, to explore the hypothesis that RANKL can modulate T regulatory cells in the tumor

Change in the quantity of tumor infiltrating lymphocytes as measured by percentage infiltration of surrounding tumor stroma and intra-tumoral on the H\&E slide pre and post treatment

Melbourne Health

Jules Bordet Institute

Women with one or more pregnancies any time after breast cancer diagnosis

Women with no subsequent pregnancies after breast cancer diagnosis

Clinical outcomes

The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.

Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

A Multicenter Retrospective Study on the Prognostic Impact of Pregnancy in Women With History of BRCA Mutated Breast Cancer

The incidence of pregnancy following breast cancer diagnosis will be computed as the ratio between the number of breast cancer survivors in the pregnant cohort and the total number of eligible patients included in the study.

To evaluate the prognostic impact of pregnancy following breast cancer diagnosis in BRCA mutated survivors, two survival endpoints will be compared between patients with and without a pregnancy following breast cancer diagnosis: disease-free survival and overall survival. Disease-free survival event is defined by the occurrence of one of the following invasive events: local recurrence, distant metastases, contralateral or ipsilateral breast tumor, second primary malignancy, or death from any cause. Overall survival event is defined as death from any cause.

Descriptive analysis aiming to evaluate the pregnancy, fetal and obstetrical outcomes of the pregnancies following breast cancer diagnosis in BRCA mutated survivors

Symptoms and General Pathology

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasm, Residual

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Gemtuzumab

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Ara-C, G-CSF, Autologous peripheral blood stem cell transplantation, Allogeneic matched related or unrelated donor transplant, G-CSF Priming, CD34+ selection, Myeloablative or reduced intensity conditioning, Mylotarg purging before autologous PBSC transplantation.

* Intermediate dose during induction phase to remission.
* High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20.

Ara-C

* In patients with favorable cytogenetics with a Leukocyte index above 20.
* Patients with normal karyotype, and one cycle of chemotherapy to achieve complete remission, without adverse molecular and/or minimal residual disease (MRD) characteristics, regardless availability of a matched donor.

Autologous peripheral blood stem cell transplantation.

-Patients without favorable/intermediate characteristics.

Allogeneic matched related or unrelated donor transplant.

* Administration at induction phase to remission, days 0 to 7. G-CSF will not be initiated if the leukocyte count is over 30x10e9/L at diagnosis or will be interrupted if the leukocyte count during treatmen arises 30x10e9/L.
* Administration at consolidation phase, days 4 to 6 (3 doses). G-CSF will be interrupted if the leukocyte count during treatment arises 30x10e9/L.

G-CSF

-Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.

CD34+ selection.

Patients without favorable/intermediate characteristics and without matched related donor.

Mylotarg purging before autologous PBSC transplantation

Jorge Sierra, MD

Salut Brunet, MD

The AML-03 regimen investigates the addition of G-CSF priming to both induction and consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793) refines risk-stratification based on biological characterization also the AML-03 trial incorporates novel approaches for hematopoietic stem cell transplantation: such as Mylotarg™ "in vivo purging" in autografts, extends unrelated volunteers donors for allotransplants in high-risk patients, and introduces reduced intensity conditioning in patients with elder age (more than 50 years old).

The aims of these modifications are to analyse eficacy and toxicity of this induction and consolidation therapy and to analyse the disease free survival in patients who achieved complete response following a risk adjusted therapy.

Induction chemotherapy: idarubicin (12mg/m2/day intravenous, days 1, 3 and 5), intermediate-dose cytarabine (500mg/m2/12h, intravenous, days 1, 3 and 5) and etoposide (100mg/m2/day, intravenous, from day 1 to 3) as in AML-99 trial (NCT01716793), with the addition of subcutaneous G-CSF from day 0 to the last day of chemotherapy. This induction therapy is repeated if complete remission (CR) is not achieved after the first course of treatment.

Consolidation therapy (as in AML-99 trial): mitoxantrone (12mg/m2/day, intravenous, days 4 to 6) and intermediate-dose cytarabine (500mg/m2/12h from day 1 to 6).

Risk-stratification according to cytogenetics, courses to CR and availability of an HLA-identical sibling:

* Patients in the favorable cytogenetics group \[t(8;21), inv(16) or t(16;16)\] and Leukocyte index \<20 at diagnosis (LI=white blood cell count (WBC) x (blasts in bone marrow/100) are treated with one course of high-dose cytarabine (3g/m2/12h, intravenous, days 1, 3 and 5), but in case of LI\>20 at diagnosis the intention is to perform an autologous peripheral blood stem cell (PBSC) transplantation.
* Patients in intermediate risk group, with normal karyotype, a single course of induction chemotherapy to achieve the CR, the absence of adverse molecular features (FLT3-ITD or MLL-PTD) and low minimal residual disease levels after consolidation (MRD\<0,1%) receive an autologous PBSC transplant, regardless of having an HLA-identical sibling.
* The remaining patients defined as high-risk patients are treated with an allogeneic stem cell transplantation. Depending on the age, if the patient has an HLA-identical sibling donor, up to age of 50 years old it is performed with conventional conditioning therapy and positive selection of CD34+, older patients receive a reduced intensity conditioning regimen.
* Very high risk patients without a sibling are allocated to unrelated donor (9-10/10). Patients with adverse cytogenetics and/or FLT3-ITD without an adequate donor received Mylotarg™ as "in vivo purging" followed by an autologous PBSC transplantation.

Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)

Risk Adapted Treatment for Primary AML in Adults, Based on Genetics and Minimal Residual Disease (MRD) in Patients up to the Age of 70 Years.

Analyze the efficacy and toxicity of IDICE-G (idarubicin, intermediate doses of ara-C and etoposide) and G-CSF to achieve complete remission.

Analyze the disease free suvival of patients in remission, with a therapeutic strategy adjusted to the prognostic factors.

Mortality in remission after chemotherapy and/or peripheral blood stem cell tranplantation.

Toxicity of the induction and intensification treatment in patients with more than 60 years old, in terms of unexpected adverse drug reaction, morbidity and mortality.

Study the immunophenotype characteristics and/or molecular markers at diagnosis, and during the different treatment phases.

Study the effect of post-remission treatments in patients with more than 60 years to evaluate the success of consolidation treatments.

Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

Amanda Toland, PhD

The purpose of this study is to identify novel genetic factors which distinguish breast cancer in younger women compared to older women. By identifying these novel genetic factors we believe more specific therapies can be developed and breast cancer may be prevented among women with an increased cancer risk. A woman does not have to live in St. Louis to participate.

Breast cancer takes its greatest toll on younger women, as it is the leading category of cancer deaths for women 20-39 years of age. Sadly, survival rates are lowest among women diagnosed at a young age. This impact is most significant among African-American women who have the highest incidence and mortality rate among women less than 45 years of age. The goal of our program is to identify the genetic factors which distinguish breast cancer in younger women compared to older women.

Women who were diagnosed with invasive breast cancer 40 years of age or younger are invited to participate. The age at diagnosis is used to determine eligibility, not a woman's current age. Women who have undergone genetic testing of the BRCA1, BRCA2, p53, pTEN, e-cadherin, or LKB1 genes are eligible to participate. Young women with breast cancer are asked to: sign a consent form, submit a sample of blood, release their cancer related records, and answer some family history questions.

We will use a family based case control approach in our analysis. As such, if a woman's parents are living, they will be invited to participate as a "comparison" group. The parents are asked to: sign a consent form, submit a sample of blood, and release any cancer records.

A woman does not have to live in St. Louis to participate. All study related materials can be mailed directly to the young woman or her parents. There is no expense to the family. All materials are kept strictly confidential and participation is completely voluntary.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)	NCT01502982	Diffuse Large B...	R-CHOEP14x6+HD-...	18 Years - 64 Years	Nordic Lymphoma Group
A Study Comparing Single Versus Double Umbilical Cord Blood Transplantation in the Young With Acute Leukemia Remission	NCT01067300	Leukemia	Transplantation...	- 35 Years	Assistance Publique Hopitaux De Marseille
A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer	NCT01864798	Breast Neoplasm...	Denosumab	18 Years -	Jules Bordet Institute
Safety of Pregnancy in BRCA Mutated Breast Cancer Patients	NCT03673306	Breast Cancer	Clinical outcom...	18 Years - 40 Years	Jules Bordet Institute
Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)	NCT01723657	Leukemia, Myelo...	Ara-C Autologous peri... Allogeneic matc... G-CSF CD34+ selection... Mylotarg purgin...	18 Years - 70 Years	Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Identification of Novel Genetic Factors That Contribute to Risk for Breast Cancer	NCT00276120	Invasive Breast...		18 Years - 80 Years	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for young

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

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