Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myelomonocytic, Juvenile

Leukemia, Myelomonocytic, Acute

Leukemia, Myelomonocytic, Chronic

Neoplasms by Histologic Type

Hematologic Diseases

Leukemia, Myeloid

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Acute Graft Versus Host Disease

Chronic Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Dermatologic Agents

Cyclophosphamide

Melphalan

Busulfan

Tretinoin

Antilymphocyte Serum

Mesna

Stem Cell Transplant

* Busulfan
* Cyclophosphamide
* Mesna
* Melphalan
* Anti-thymocyte Globulin (ATG)

Preparative Regimen

Margaret MacMillan, MD

The investigators hypothesize that long-term disease-free survival (DFS) in patients with JMML can be achieved with a treatment of busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by hematopoietic cell transplantation (HCT).

Prior to transplantation, subjects will receive BUSULFAN via the central venous line, six times a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days, and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and melphalan are given to destroy the subject's leukemia. As well, these drugs will destroy the subject's own immune system to help ensure the new bone marrow takes and grows after transplantation.

On the day of transplantation, bone marrow or umbilical cord blood from the donor will arrive to the bone marrow transplant unit and be transfused via venous line. These new cells will replace the subject's bone marrow.

Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)

Hematopoietic Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia

Masonic Cancer Center, University of Minnesota

Patients receiving study regimen.

Stem Cell Transplant: Transplantation on Day 0.

Preparative Regimen: - Busulfan

* Cyclophosphamide
* Mesna
* Melphalan
* Anti-thymocyte Globulin (ATG)

Intent-to-Treat

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Margaret MacMillan, MD

Determine Probability of Long-term Disease Free Survival in JMML

Combined Incidence of Neutrophil Engraftment, Graft-versus-host Disease (GVHD), Regimen-related Toxicity, and Relapse.

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Death

Breast Diseases

Skin Diseases

Blood samples will be collected on the first day of the first cycle of chemotherapy (before injection of chemotherapy), on the first day of the third cycle (before injection of chemotherapy), on day of surgery and 6 months after surgery and in case of relapse.

Tumor samples will be collected on diagnosis, on surgery and on the first day of the third chemotherapy course (optional).

Blood and tumor sample

Olivier TREDAN, MD

This is a prospective, non-randomized study which aims to evaluate the response to a neoadjuvant chemotherapy according to the the antitumor immune response in localized breast cancer.

40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4 anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles.

Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated and receive an adjuvant treatment which will both depend on the investigator's appreciation.

Blood sample will be collected on the first day of the first chemotherapy cycle, on the first day of the third cycle, on surgery, 6 months after the surgery and in case of relapse.

Tumor sample will be collected on diagnosis as much as possible and on surgery.

Patients will be followed during 5 years.

Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer

Rate of histopathologic response (IHC). Analysis of lymphocyte subpopulations (whole blood - flow cytometry). Analysis of the frequency of immune cells, the phenotype and functional status on the site of the tumor (fixed tissue - IHC). Analysis of the functional status of sub-populations of DC and lymphocytes of innate immunity (fresh whole blood - flow cytometry). Analysis of BCR and TCR repertoires (mononuclear cells - PCR). Identification of TAA expressed by the tumor (plasma, tumor - ELISA, IHC).Analysis of the humoral response against TAA (plasma - ELISA).

Analysis in plasma of the rate of apoptotic tumor cells, of TAA (CEA and MUC1 ELISA), of tumor DNA and endogenous ligands of TLR (HMGB1 ELISA) Assay of cytokines and chemokines in plasma Analysis of the expression of proteins involved in the translocation of CRT to the cell surface (fixed-frozen tissue - IHC or immunoblotting) Analysis on the tumor (IHC or immunoblotting) of degradation of BAP31, activation of caspase 8/Bax/Bak, phosphorylation of eIF2 and exposure of surface CRT, KDEL receptor and ERp57

Analysis of P2X7 and TLR4 polymorphisms on circulating cells (plasma)

Centre Leon Berard

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stem Cell Transplant for Juvenile Myelomonocytic Leukemia (JMML)	NCT00167219	Juvenile Myelom...	Stem Cell Trans... Preparative Reg...	- 18 Years	Masonic Cancer Center, University of Minnesota
Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer	NCT01440413	Breast Cancer	Blood and tumor...	18 Years -	Centre Leon Berard
Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer	NCT01440413	Breast Cancer	Blood and tumor...	18 Years -	Centre Leon Berard

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