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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Nr. 2008-001430-27 | |||
| ML21718 |
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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
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The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.
This is a non-randomized, multicenter, open-label, single-arm Phase I/II study in patients with previously untreated CD20-positive CLL. Phase I of the study will evaluate the maximal tolerated lenalidomide dose level in combination with fludarabine/rituximab chemoimmunotherapy in 10 patients. Phase II will determine efficacy using the combination in the previously defined maximal tolerated dose. Both phases will be followed by a maintenance phase evaluating the tolerability and possibility to further improve response quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Lenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Dose escalation stage: starting dose 2.5mg/d, dose escalation via 5/10/15/20/25 mg/d every 28 days if no dose-limiting toxicity. During maintenance stage dosing on days 1-28 for max. 6 months at maximum tolerated dose reached during dose escalation stage. |
| Measure | Description | Time Frame |
|---|---|---|
| Lenalidomide Maximum Tolerated Dose | Dose escalation stage |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of Lenalidomide/Fludarabine/Rituximab treatment | Study Duration | |
| Safety Profile of Lenalidomide/Rituximab | Study duration | |
| Response rate for Lenalidomide/Fludarabine/Rituximab combination treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Greil, Prof. Dr. | Universitaetsklinik f. Innere Medizin III, Universitaetsklinikum der PMU, Salzburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie | Innsbruck | Tyrol | A-6020 | Austria | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29862437 | Derived | Egle A, Steurer M, Melchardt T, Weiss L, Gassner FJ, Zaborsky N, Geisberger R, Catakovic K, Hartmann TN, Pleyer L, Voskova D, Thaler J, Lang A, Girschikofsky M, Petzer A, Greil R. Fludarabine and rituximab with escalating doses of lenalidomide followed by lenalidomide/rituximab maintenance in previously untreated chronic lymphocytic leukaemia (CLL): the REVLIRIT CLL-5 AGMT phase I/II study. Ann Hematol. 2018 Oct;97(10):1825-1839. doi: 10.1007/s00277-018-3380-z. Epub 2018 Jun 4. |
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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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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
| Fludarabine | Drug | 25 mg/m2 i.v. d1-3 or 40 mg/m2 po d1-3 every 28 days for 6 cycles during dose escalation stage. |
|
|
| Rituximab | Biological | Dose escalation stage: 375 mg/m2 i.v. d4 Cycle 1, 500 mg/m2 i.v. d1 Cycles 2-6. Maintenance stage: 375 mg/m2 i.v. at 2/4/6 months after end of escalation stage. |
|
|
| Dose escalation stage |
| Response rate for Lenalidomide/Rituximab combination therapy | Study Duration |
| Response rate by 4-colour flow cytometric MRD analysis | Study Duration |
| Changes in Quality of Life scores | Study Duration |
| Risk factors and clonal evolution | Study Duration |
| Landeskrankenhaus Feldkirch |
| Feldkirch |
| A-6806 |
| Austria |
| Krankenhaus d. Barmherzigen Schwestern Linz | Linz | A-4010 | Austria |
| Krankenhaus der Elisabethinen Linz GmbH | Linz | A-4010 | Austria |
| Krankenhaus der Stadt Linz | Linz | A-4020 | Austria |
| Universitaetsklinik f. Innere Medizin III | Salzburg | A-5020 | Austria |
| Klinikum Wels-Grieskirchen GmbH | Wels | A-4600 | Austria |
| 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 |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |