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Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

9 juin 2017 mis à jour par: Roswell Park Cancer Institute

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

45

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New York
      • Buffalo, New York, États-Unis, 14263-0001
        • Roswell Park Cancer Institute

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 120 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Biologique: rituximab
IV
Médicament: lenalidomide
Oral

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Roswell Park Cancer Institute

Collaborateurs

Celgene

Les enquêteurs

  • Chercheur principal: Kelvin Lee, MD, Roswell Park Cancer Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2004

Achèvement primaire (Réel)

1 juin 2015

Achèvement de l'étude (Réel)

1 juin 2015

Dates d'inscription aux études

Première soumission

9 novembre 2004

Première soumission répondant aux critères de contrôle qualité

8 novembre 2004

Première publication (Estimation)

9 novembre 2004

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juillet 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juin 2017

Dernière vérification

1 juin 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CDR0000391767
  • RPCI-I-18103 (Autre identifiant: Roswell Park Cancer Institute)
  • CELGENE-RV-CLL-PI-005 (Autre subvention/numéro de financement: Celgene)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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