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Trial record 38 of 495 for:    LENALIDOMIDE AND every 28 days

Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas (LeMLAR)

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ClinicalTrials.gov Identifier: NCT01788189
Recruitment Status : Active, not recruiting
First Posted : February 11, 2013
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Ulrich Duehrsen, University Hospital, Essen

Brief Summary:

Multicenter prospective open-label non-randomised phase I/II study in patients with relapsed or refractory CD20-positive aggressive lymphomas

Phase I:

Dose escalation of methotrexate and cytarabine (days 1, 8 and 15 of each 28-day cycle) in a 3 + 3 design with fixed doses of lenalidomide (days 1 - 21) and rituximab (day 1), maximum 6 cycles

Phase II:

Treatment of 20 patients at maximum tolerated doses of phase I


Condition or disease Intervention/treatment Phase
B-cell Lymphoma Drug: Lenalidomide Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lenalidomide in Conjunction With Methotrexate, Leucovorin, Cytarabine and Rituximab for the Treatment of Relapsed or Refractory CD20-positive Aggressive Lymphomas: an Open-label, Multicenter Phase I/II Trial
Study Start Date : January 2013
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Lenalidomide

The LeMLAR protocol:

Lenalidomide 25 mg p.o., days 1 - 21; Methotrexate 30 - 60 - 90 - 120 - 150 mg/m² i.v. bolus, days 1, 8, 15; Leucovorin 4 x 45 mg p.o. (every 6 hrs), days 2, 9, 16; Cytarabine (Ara-C) 75 - 150 - 225 - 300 - 375 mg/m² i.v. bolus, days 1, 8, 15; Rituximab 375 mg/m² i.v. infusion, day 1.

28-day cycles, maximum 6 cycles, definition of dose-limiting toxicity in cycles 1 and 2, intra-patient dose escalation after cycles 2 and 4 in case of absence of dose-limiting toxicity in previous cycles

Drug: Lenalidomide



Primary Outcome Measures :
  1. Dose-limiting toxicity [ Time Frame: Two months ]

    Phase I:

    Dose-limiting toxicity of the combination regimen, determination of the maximum tolerated doses of methotrexate and cytarabine

    Phase II:

    Overall response rate (percentage of complete and partial remissions combined)



Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Relapse rate [ Time Frame: 1 year ]
  2. Event-free survival [ Time Frame: 1 year ]
  3. Disease-free survival [ Time Frame: 1 year ]
  4. Overall survival [ Time Frame: 1 year ]
  5. Toxicity (type, onset, duration) [ Time Frame: 1 year ]
  6. Secondary malignancies [ Time Frame: 5 years ]
  7. Complete remission rate [ Time Frame: Six months ]
  8. Partial remission rate [ Time Frame: Six months ]
  9. Rate of stable disease [ Time Frame: Six months ]
  10. Rate of progressive disease [ Time Frame: Six months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Performance status ECOG 0 - 3
  • First or subsequent relapse or refractoriness of a biopsy-proven CD20-positive aggressive B cell lymphoma (excluding mantle cell lymphoma)
  • Measurable disease
  • Ineligibility or unwillingness to undergo high-dose chemotherapy with autologous stem cell transplantation
  • Ability to understand the aim of the study and act accordingly
  • Effective contraception
  • Signed informed consent

Exclusion Criteria:

  • Central nervous system relapse of aggressive lymphoma
  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  • Any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he/she were to participate in the study
  • Any condition that confounds the ability to interpret data from the study
  • Inadequate organ function not related to aggressive lymphoma:

    • neutrophils < 1.0/nl
    • platelets < 75/nl
    • creatinine clearance < 60 ml/min
    • bilirubin ≥ 2,5 mg/dl
    • serum AST/GOT or ALT/GPT ≥ 4 x upper limit of normal
  • Active viral hepatitis (HBV, HCV), HIV infection, any other uncontrolled infection
  • Pregnancy and nursing period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788189


Locations
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Germany
Klinik für Hämatologie, Universitätsklinikum Essen
Essen, Germany, 45147
Sponsors and Collaborators
University Hospital, Essen
Celgene
Investigators
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Principal Investigator: Ulrich Dührsen, MD Klinik für Hämatologie, Universitätsklinikum Essen

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Responsible Party: Ulrich Duehrsen, Prof. Dr. med., University Hospital, Essen
ClinicalTrials.gov Identifier: NCT01788189     History of Changes
Other Study ID Numbers: EudraCT No. 2012-001891-13
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Keywords provided by Ulrich Duehrsen, University Hospital, Essen:
Lymphoma
CD20
Relapse
Lenalidomide
Additional relevant MeSH terms:
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Lenalidomide
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Rituximab
Methotrexate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors
Angiogenesis Inhibitors