Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators:
Celgene Corporation
Roche Pharma AG
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00738829
First received: August 20, 2008
Last updated: May 9, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Lymphocytic, Chronic, B-Cell |
Drug: Lenalidomide Drug: Fludarabine Biological: Rituximab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide Followed by Rituximab/Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Concomitant Evaluation of Safety and Efficacy. |
Resource links provided by NLM:
Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
Primary Outcome Measures:
- Lenalidomide Maximum Tolerated Dose [ Time Frame: Dose escalation stage ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety profile of Lenalidomide/Fludarabine/Rituximab treatment [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
- Safety Profile of Lenalidomide/Rituximab [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
- Response rate for Lenalidomide/Fludarabine/Rituximab combination treatment [ Time Frame: Dose escalation stage ] [ Designated as safety issue: No ]
- Response rate for Lenalidomide/Rituximab combination therapy [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
- Response rate by 4-colour flow cytometric MRD analysis [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
- Changes in Quality of Life scores [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
- Risk factors and clonal evolution [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment Arm
Lenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy
|
Drug: Lenalidomide
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. Other Name: Revlimid
Drug: Fludarabine
25 mg/m2 i.v. d1-3 or 40 mg/m2 po d1-3 every 28 days for 6 cycles during dose escalation stage.
Other Name: Fludarabine phosphate
Biological: Rituximab
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. Other Name: MabThera
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- B-CLL (CD23+, CD5+, CD19+, CD20+)
- Treatment indication according to NCI criteria
- Age >= 18 yrs
- No previous treatment of CLL by chemo-, radio- or immunotherapy
- Life expectancy > 6 months
- Written informed consent
- Women of non-childbearing potential or women of childbearing potential and men using effective contraception
Exclusion Criteria:
- Active bacterial, viral or fungal infection
- Positivity for HIV, Hepatitis B or C
- Reduce organ functions and bone marrow dysfunction not due to CLL
- Creatinine clearance below 30 ml/min
- Patients with medical conditions requiring long-term use of systemic corticosteroids during study treatment
- Patients with a history of severe cardiac disease
- Other known co-morbidity with the potential to dominate survival
- Transformation to aggressive B-cell malignancy
- Known hypersensitivity to humanised monoclonal antibodies or any of the study drugs
- Pregnant or breast-feeding women
- Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738829
Locations
| Austria | |
| Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie | |
| Innsbruck, Tirol, Austria, A-6020 | |
| Landeskrankenhaus Feldkirch | |
| Feldkirch, Austria, A-6806 | |
| Krankenhaus d. Barmherzigen Schwestern Linz | |
| Linz, Austria, A-4010 | |
| Krankenhaus der Elisabethinen Linz GmbH | |
| Linz, Austria, A-4010 | |
| Krankenhaus der Stadt Linz | |
| Linz, Austria, A-4020 | |
| Universitaetsklinik f. Innere Medizin III | |
| Salzburg, Austria, A-5020 | |
| Klinikum Wels-Grieskirchen GmbH | |
| Wels, Austria, A-4600 | |
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Celgene Corporation
Roche Pharma AG
Investigators
| Principal Investigator: | Richard Greil, Prof. Dr. | Universitaetsklinik f. Innere Medizin III, Universitaetsklinikum der PMU, Salzburg |
More Information
No publications provided
| Responsible Party: | Prof. Dr. Richard Greil, Arbeitsgemeinschaft medikamentoese Tumortherapie gemeinnuetzige GmbH |
| ClinicalTrials.gov Identifier: | NCT00738829 History of Changes |
| Other Study ID Numbers: | CLL-5, EudraCT Nr. 2008-001430-27, ML21718 |
| Study First Received: | August 20, 2008 |
| Last Updated: | May 9, 2011 |
| Health Authority: | Austria: Agency for Health and Food Safety Austria: Ethikkommission |
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
|
CLL untreated immune therapy dose escalation maximum tolerated dose |
maintenance therapy Lenalidomide Rituximab Fludarabine |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Fludarabine Fludarabine monophosphate Rituximab Lenalidomide Thalidomide |
Vidarabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Antirheumatic Agents Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013