- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00096044
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
Primary
- Determine the best cytostatic response rate (including complete response, partial response, or stable disease) in patients with relapsed or refractory chronic lymphocytic leukemia treated with lenalidomide (CC-5013).
Secondary
- Determine the cytostatic response rate in patients who progress on CC-5013 and are then treated with CC-5013 and rituximab.
- Determine the safety of these regimens in these patients.
- Determine time to progression in patients treated with these regimens.
OUTLINE: This is an open-label, non-randomized, pilot study.
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond CR.
Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of further disease progression. Patients who achieve CR receive 2 additional courses beyond CR.
Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
New York
-
Buffalo, New York, Vereinigte Staaten, 14263-0001
- Roswell Park Cancer Institute
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry
- Relapsed or refractory disease
Measurable disease, defined by 1 of the following criteria:
- Absolute lymphocyte count ≥ 5,000/mm^3
- Measurable lymphadenopathy or organomegaly
- Received ≥ 1 prior therapy for CLL
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 30,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
Renal
- Creatinine ≤ 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation
- No known hypersensitivity to thalidomide
- No erythema nodosum characterized by a desquamating rash after prior thalidomide or similar drug administration
- No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins
- No serious medical condition or laboratory abnormality that would preclude study participation
- No psychiatric illness that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior lenalidomide (CC-5013)
- No concurrent thalidomide
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- At least 4 weeks since prior therapy for CLL
- At least 28 days since prior experimental drug or therapy
- No other concurrent anticancer therapies
- No other concurrent investigational agents
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Oral Lenalidomide
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21.
Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
|
IV
Oral
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months
Zeitfenster: at 6 Months
|
Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria.
CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules.
PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline.
Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.
|
at 6 Months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab
Zeitfenster: 5 years
|
Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria.
CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count >1500/μL; platelet count >100,000/μL; untransfused hemoglobin concentration >11.0g/dL; lymphocyte count <4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules.
PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline.
Patients who have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.
|
5 years
|
Number of Participants With Adverse Events on Single Agent CC-5013
Zeitfenster: 1 year
|
Number of Participants with Adverse Events on Single Agent CC-5013, Graded According to NCI CTCAE Version 3.0 Please refer to the adverse event reporting for more detail. |
1 year
|
Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab
Zeitfenster: Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.
|
Number of Participants with Adverse Events on Combination Therapy of CC-5013+Rituximab, Graded According to NCI CTCAE Version 3.0
|
Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.
|
Time to Progression for Single Agent CC-5013
Zeitfenster: 5 years
|
Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.
|
5 years
|
Time to Progression for the Combination Therapy of CC-5013+Rituximab
Zeitfenster: Every month up to 6 months and every 3 months thereafter up to 5 years
|
Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.
|
Every month up to 6 months and every 3 months thereafter up to 5 years
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kelvin Lee, MD, Roswell Park Cancer Institute
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Lymphoproliferative Erkrankungen
- Lymphatische Erkrankungen
- Immunproliferative Erkrankungen
- Leukämie, B-Zell
- Leukämie
- Leukämie, lymphozytär, chronisch, B-Zell
- Leukämie, lymphatisch
- Physiologische Wirkungen von Arzneimitteln
- Antirheumatika
- Antineoplastische Mittel
- Immunologische Faktoren
- Antineoplastische Mittel, immunologische
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Lenalidomid
- Rituximab
Andere Studien-ID-Nummern
- CDR0000391767
- RPCI-I-18103 (Andere Kennung: Roswell Park Cancer Institute)
- CELGENE-RV-CLL-PI-005 (Andere Zuschuss-/Finanzierungsnummer: Celgene)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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