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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00728-33 | Other Identifier | French ANSM |
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The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without AMA | Other | Patient will be follow only like usual practice |
|
| With AMA | Other | Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Intervention | Other | Only for arm AMA, patient will have one phone every week to evaluate physical conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of RDI | Reductions in Relative Dose Intensity, calculated as the difference between initially planned doses of F, C and R and effectively prescribed doses of the 3 drugs, before and after 6 courses of FCR. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Toxicity grade III-IV | rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy. | 3 years |
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Inclusion Criteria:
CLL whatever Binet stage, but with at least one NCIWG2008 criteria indicating a need for first line treatment.
Eligibility to a treatment with FCR: clearance > 60ml/mn, consider dose adjustments (recommended by protocol) if clearance30-60ml/mn, and comorbidity score CIRS-G≤11.
Signed informed consent
Age> or equal 18 years, ECOG PS 0-2.
Estimated overall survival>6 months.
Conserved liver function (bilirubin<2,5mg/dl, SGPT<4ULN, SGOT<4ULN) except infiltration due to the disease.
Contraception for younger patients.
Confident with the use of telephone, no disabling deafness.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loïc YSEBAERT, MD | University Hospital Of Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de la côte basque | Bayonne | 64109 | France | |||
| CH Saint Jean |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30778715 | Result | Ysebaert L, Larcher M, Compaci G, Oberic L, Sahnes L, Banos A, Araujo C, Sommet A, Laurent G, Despas F. Oncology nurse phone calls halve the risk of reduced dose intensity of immunochemotherapy: results of the randomized FORTIS study in chronic lymphocytic leukemia. Ann Hematol. 2019 Apr;98(4):931-939. doi: 10.1007/s00277-019-03631-z. Epub 2019 Feb 18. |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| Usual Practice | Other | None, only usual practice. |
|
| Perpignan |
| 66046 |
| France |
| CHU Purpan | Toulouse | 31059 | France |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |