Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Thymoglobulin

Busulfan

Immunosuppressive Agents

Immunologic Factors

Alkylating Agents

Antineoplastic Agents, Alkylating

study :

* acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post transplantation
* the effectiveness of the protocol on tumor response
* overall survival

Fludarabine, Busulfan, Thymoglobulin

Lacarin Patrick

Paillard Catherine, Dr

To assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation chimerism and hematological reconstitution.

To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post-transplantation To study the effectiveness of the protocol on tumor response.

To study overall survival.

Primary criterion

* Hematological reconstitution and chimerism post-transplantation

Secondary criteria

* Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
* Analysis of variations in post-transplantation immunological function profiles
* Median duration of response in therapy-responsive patients and median duration of stability in stabilized patients

Allogeneic Hematopoietic Stem Cell Transplantation

Feasibility Study on Allogeneic Hematopoietic Stem Cell Transplantation Following Fludarabine-Busulfan-ALS-based Reduced-intensity Conditioning in Children With Hematological Malignancy or Solid Tumor Not Responding to Standard Therapy or for Which the Indication for Allograft is Maintained But Cannot be Carried Out Due to the Toxicity Involved in Myeloablative Conditioning.

University Hospital, Clermont-Ferrand

Dr Catherine PAILLARD

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Influenza, Human

Fludarabine (30mg/m²/5 days) Oral Busulfan (8 mg/kg over 2 days) Thymoglobuline (2.5 mg/m²/1day).

comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)

reduced intensity conditionings

Didier BLAISE, PUPH

This study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (RIC).

Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day).

Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation (TBI).

A randomization of 2 phase study according to the methodology developed by Liu et al (Liu, 1993 and 2001) for the evaluation of multiple innovative approaches.

Primary endpoint is one year overall survival (OS). Stopping rules included excessive engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an independent safety review board (ISRB).

Inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable HLA identical sibling. All patients and donors are included after giving written informed consent.

Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular therapies committee (national agency).

A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation

A Multicenter Prospective Randomized Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation

Institut Paoli-Calmettes

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Nervous System Diseases

Syndrome

Congenital Abnormalities

Constriction, Pathologic

Intervertebral Disc Displacement

Intervertebral Disc Degeneration

Spondylolisthesis

Spinal Stenosis

Bone Marrow Diseases

Spinal Cord Neoplasms

Failed Back Surgery Syndrome

Spinal Cord Diseases

Spinal Diseases

Bone Diseases

Central Nervous System Diseases

Postoperative Complications

Back Pain

Pain

Neurologic Manifestations

Hernia

Pathological Conditions, Anatomical

Central Nervous System Neoplasms

Nervous System Neoplasms

Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft).

spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft

Bone graft substitute, autograft or allograft

Huub Kreuwel, Ph.D

A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.

Bone Graft Materials Observational Registry

A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

Apatech, Inc.

Baxter Healthcare Corporation

Heart and Blood Diseases

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

reduced intensity conditioning for allogenic transplant

reduced intensity conditioning

Mauricette Michallet, MD

Donor mobilization :

Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days.

Hematopoïetic Stem Cell Harvest:

By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ \>= 2 and \<= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG

* D-5 : Fludarabine (30 mg/m²)
* D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)
* D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)
* D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg)
* D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at 3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with an anti A/B antibodies titer\> 1/32.

Transplant : HSC at D0

• 3 months after Transplantation :

Disease Evaluation :

* If CR : Supervision. Then if progression: 4 cycles of Bortezomib.
* If no CR : Bortezomib (4 cycles)

  • Evaluation after Bortezomib cycles
* If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI

Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning

Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning (IFM 2005-03)

Hospices Civils de Lyon

Mouth and Tooth Diseases

Digestive System Diseases

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

preventive treatment performed by nurses of mucositis by laser treating daily by scanning the entire oral cavity for 2 minutes with a power of 250 mW associated with mouthwashes several times a day (standard preventive treatment of mucositis)

daily laser-off session performed by nurses associated with mouthwashes several times a day (standard preventive treatment of mucositis)

Patients randomized to the experimental arm receive in addition to mouthwash, preventive treatment of mucositis by LLLT performed by nurses consisting of daily scanning the entire oral cavity for 2 minutes with a power of 250 mW, starting with conditioning and ongoing until the onset of mucositis of grade 1.

If the mucositis is localised, preventive laser will be kept on the healthy zones, and curative laser will be performed on painful zone. If the mucositis is general (more than 1 site), preventive laser is stopped for curative laser only.

Laser treatment

Patients randomized to the Placebo arm receive in addition to mouthwash fictive laser treatment performed by nurses until the onset of mucositis of grade 1.

If the mucositis is localised, fictive laser will be kept on the healthy zones, and curative laser will be performed on painful zone. If the mucositis is general (more than 1 site), fictive laser is stopped for curative laser only.

Placebo

Emmanuelle TAVERNIER, MD

The LLLT has an anti-inflammatory, analgesic effect and accelerates the healing of ulcerated lesions. There are little data in the literature showing its efficacy in prevention of mucositis in cohorts of patients with hematopoietic stem cells transplantation.

The main objective of this study is to assess the efficacy of a prophylactic low level laser therapy performed by nurses on the severity of oral mucositis during HSCT.

The main end point for efficacy is the reduction of severe mucositis (grade 3 or more). The secondary efficacy endpoints are the reduction of mucositis, whatever the grade, the reduction of time with mucositis, the time to onset of mucositis symptoms, the reduction of pain intensity and evaluation of quality of life.The secondary endpoints for safety are severe adverse events and potential toxicity. Patients will be allocated at inclusion with a 1/1 ratio either to laser-on or laser-off groups. In the laser group, patients will undergo laser therapy performed by nurses, which will consist of irradiation of the whole oral cavity during 2 minutes with 250mW power. In the laser-off group, laser therapy will be carried out with equipment off during the same time, and still performed by nurses. Protective eye shields will be used to avoid detrimental effects on eyes and to keep the subjects blind.

Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation

Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation : a Randomized Double Blind Multicenter Prospective Phase III Trial

prevalence of grade 3 and more mucositis following the classification proposed by WHO (world health organization)

The number of all grades of mucositis will be reported at day 30 post graft for all patients.

The duration of mucositis will be reported at day 30 post graft for all patients.

time of onset of mucositis will be assessed by measuring the interval between the beginning of packaging and the first day of mucositis has been assessed at a grade 1

Pain will be reported for each patient during their participation: 30 days post graft maximum.

Quality of life will be reported for each patient during their participation: 30 days post graft maximum.

serious adverse events will be reported for each patient during their participation: 30 days post graft maximum.

Centre Leon Berard

Société Biophoton

Institut de Cancérologie de la Loire

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Preleukemia

Myelodysplastic Syndromes

Wilms Tumor

Precancerous Conditions

Myeloproliferative Disorders

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Wilms' Tumor

Chronic Myeloproliferative Disorders

6 administration every 2 weeks of intra-muscular 200 micrograms of protein recwt1-A10+AS01B at week 1, 3, 5, 7, 9 and 11.

recwt1-A10+AS01B

Didier BLAISE, MD PhD

Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.

If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft.

6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.

The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.

Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy

Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches

Dose limit toxicity (adverse event according to CTCAE V4.0)

The specific WT1 antibody induced by the vaccination will be evaluated by the technic ELISA in UE/ml.

* Eligible for allo-HSCs from peripheral blood stem cells from a compatible donor HLA family (Appendix 1, the pre-transplant assessment must be enabled)
* In a complete remission rate of leucocytes with ≥ 2G / L
* Affiliated to social security person or beneficiary of such a scheme.

* Member of the siblings and HLA-matched A, B, Cw, DR, DQ
* Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled)
* Having a rate of circulating lymphocytes ≥ 1 G / L
* Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population
* The statutes CMV and EBV are known (positive or negative).
* Affiliated to social security person or beneficiary

assessment pre-donation of hematopoietic stem cells (blood sample)

blood

YAKOUB-AGHA IBRAHIM, Professor

This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.

The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes.

This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.

The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes , T lymphocytes CD4 + CCR7 + donor will be stimulated by mature dendritic cells (DC) derived from recipient circulating monocytes in a mixed lymphocyte reaction model sensitized ( MLDCR ) , experiencing HLA -compatibility . This first step will confirm the results previously obtained in a situation incompatible HLA .

Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft

Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft

Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.

Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)

Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Allogeneic Hematopoietic Stem Cell Transplantation	NCT00750126	Solid Tumors Hematologic Neo...	Fludarabine, Bu...	- 20 Years	University Hospital, Clermont-Ferrand
A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation	NCT00894049	Allograft Allogeneic Cell... Hematological M... Solid Tumor	reduced intensi...	18 Years - 65 Years	Institut Paoli-Calmettes
Bone Graft Materials Observational Registry	NCT00974623	Degenerative Di... Herniated Disc Spinal Stenosis Spondylolithesi... Spinal Deformit... Cervical Myelop... Failed Back Sur... Spinal Cord Neo...	Bone graft subs...	18 Years -	Baxter Healthcare Corporation
Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning	NCT00466674	Myeloma	reduced intensi...	18 Years - 65 Years	Hospices Civils de Lyon
Efficacy of Prophylactic Low Level Laser Therapy (LLLT) Performed by Nurses for Decreasing Severity of Oral Mucositis During Hematopoietic Stem Cell (HSC) Transplantation	NCT02696408	Hematologic Mal...	Laser treatment Placebo	18 Years -	Institut de Cancérologie de la Loire
A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation	NCT00894049	Allograft Allogeneic Cell... Hematological M... Solid Tumor	reduced intensi...	18 Years - 65 Years	Institut Paoli-Calmettes
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy	NCT01819558	Acute Myeloid L... Chronic Myeloid... Myelodysplastic...	recwt1-A10+AS01...	18 Years - 65 Years	Institut Paoli-Calmettes
Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft	NCT03280290	Acute Myeloblas...	blood	18 Years -	University Hospital, Lille
Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft	NCT03280290	Acute Myeloblas...	blood	18 Years -	University Hospital, Lille
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy	NCT01819558	Acute Myeloid L... Chronic Myeloid... Myelodysplastic...	recwt1-A10+AS01...	18 Years - 65 Years	Institut Paoli-Calmettes

Spots Global Cancer Trial Database for allograft

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

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