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Trial record 43 of 178 for:    LENALIDOMIDE AND Leukemia

Activity & Safety Study of Lenalidomide & Rituximab as Non-chemotherapy Based Therapy on Chronic Lymphocytic Leukemia (LLC-LENAR-08)

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ClinicalTrials.gov Identifier: NCT01185262
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : September 30, 2013
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
MD Anderson International Spain SA

Tracking Information
First Submitted Date  ICMJE December 17, 2009
First Posted Date  ICMJE August 19, 2010
Last Update Posted Date September 30, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2013)
Phase I: To determine Starting Recommended Dose for the first cycle and the subsequent cycles (Maximal Tolerated Dose)in relapsed B-cell CLL patients. [ Time Frame: 5 months ]
6 treatment cycles followed by an evaluation visit (between 60-90 days after last dosing) and quarterly follow up visits, until disease progression. Module I: patients on every cohort will have the same dose during treatment, except if they experiment DLT, in which case dose will be decreased (unless they are on the first dose level).
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • Phase I: To determine Starting Recommended Dose for the first cycle and the subsequent cycles (Maximal Tolerated Dose)in relapsed B-cell CLL patients Phase II: To determine the clinical response rate (combined morphological and flow cytometry criteria). [ Time Frame: 5 months ]
    6 treatment cycles followed by an evaluation visit (between 60-90 days after last dosing) and quarterly follow up visits, until disease progression. Module I: patients on every cohort will have the same dose during treatment, except if they experiment DLT, in which case dose will be decreased (unless they are on the first dose level). Module II: confirmation of the DLT, patients will have incresing dose on every cycle in order to confirm the DLT
  • Phase II: To determine the clinical response rate (combined morphological and flow cytometry criteria). [ Time Frame: 5 months ]
    6 treatment cycles followed by an evaluation visit (between 60-90 days after last dosing) and quarterly follow up visits, until disease progression
Change History Complete list of historical versions of study NCT01185262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2013)
  • To determine the toxicity profile of LenRtx. [ Time Frame: 5 months ]
    Phase II: patients will be followed during 6 cycles, safety assessment visit and quarterly follow up visits
  • To determine the time to treatment failure. [ Time Frame: 5 months ]
    Phase II: patients will be followed during 6 cycles, safety assessment visit and quarterly follow up visits
  • To determine the molecular response rate. [ Time Frame: 5 months ]
    Phase II: patients will be followed during 6 cycles, safety assessment visit and quarterly follow up visits
  • To determine the clinical response rate (combined morphological and flow cytometry criteria). [ Time Frame: 5 months ]
    6 treatment cycles followed by an evaluation visit (between 60-90 days after last dosing) and quarterly follow up visits, until disease progression
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2010)
  • To determine the toxicity profile of LenRtx. [ Time Frame: 5 months ]
    Phase II: patients will be followed during 6 cycles, safety assessment visit and quarterly follow up visits
  • To determine the time to treatment failure. [ Time Frame: 5 months ]
    Phase II: patients will be followed during 6 cycles, safety assessment visit and quarterly follow up visits
  • To determine the molecular response rate. [ Time Frame: 5 months ]
    Phase II: patients will be followed during 6 cycles, safety assessment visit and quarterly follow up visits
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Activity & Safety Study of Lenalidomide & Rituximab as Non-chemotherapy Based Therapy on Chronic Lymphocytic Leukemia
Official Title  ICMJE Phase I Study of the Activity and Safety of Lenalidomide and Rituximab as Non-chemotherapy Therapy for Patients With Recurrent and Refractory Chronic Lymphocytic Leukemia
Brief Summary

The rationale for combining lenalidomide with rituximab derives from preclinical observations suggesting that lenalidomide may enhance the ADCC (antigen-dependent cellular cytotoxicity) triggered by monoclonal antibodies such as rituximab. Lenalidomide augments NK cytotoxicity by increasing CD56dimCD3 subset, in addition to inducing IL-2 in T cells. These results provide the cellular and molecular basis for the use of lenalidomide as an adjuvant in immunotherapeutic strategies of monoclonal antibodies (mAb)-based therapies. The combination lenalidomide-rituximab was tested in lymphoma cell lines but not specifically on CLL cell lines. However the observed synergism was attributed to NK cells expansion, thus lending support to the notion that this synergism may operate in other B-cell lymphoproliferative malignancies.

The objective was to develop a non-cytotoxic and effective treatment for CLL that would fulfill an unmet medical need, as a significant proportion of CLL patients are elderly and frail. These patients experience an excess in chemotherapy induced toxicity, often preventing the completion of the planned treatment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE Drug: Lenalidomida and Rituximab

Lenalidomide: Oral use. It will be administered from day 1 to 21 of 28 days cycles in a total of 6 cycles.

Rituximab, intravenous use. The dose will be administered at the standard (375 mg/m2 in the first cycle and 500 mg/m2 in successive cycles).

In the first cycle Rituximab will be administered in two divided doses:100mg/m2 total on day 1 and the rest up to 375mg/m2 on day 2.

If lenalidomide treatment starts on day 1, Rituximab will be administered, in this first cycle, on days -2 (100 mg/m2) and -1 (275 mg/m2).

In the second and subsequent cycles, 500 mg/m2 of Rituximab will be administered on day -1.

Other Names:
  • Lenalidomide: REVLIMID
  • Rituximab: MABTHERA
Study Arms  ICMJE Experimental: Lenalidomida, Rituximab
Phase I: Lenalidomide will be administered from day 1 to 21 of 28 days cycles, escalating doses (from 2,5mg to 25 mg).Rituximab dose will be administered at the standard (375 mg/m2 in the first cycle and 500 mg/m2 in successive cycles).
Intervention: Drug: Lenalidomida and Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2013)
25
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2010)
42
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Recurrent and refractory CLL patients that have received at least one previous treatment with purine analogs.
  • Adequate liver function and renal function.
  • ECOG performance status ≤ 2.
  • Signed informed consent
  • Male and female patients who are fertile agree to use an effective barrier method of birth control to avoid pregnancy.

Exclusion Criteria:

  • Positive serological markers for hepatitis B with the exception of HBsAc in previously vaccinated patients
  • Pregnant patients
  • HIV infection
  • Concurrent chemotherapy or immunotherapy
  • Other malignancy within the last 2 years, except for localized cutaneous carcinoma
  • Neurological impairment precluding understanding of protocol and the entailed visits and procedures.
  • Patients with Renal insufficiency that requires dialysis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01185262
Other Study ID Numbers  ICMJE LLC-LENAR-08
LLC-LENAR-08 ( Other Identifier: Fundación MD Anderson Internacional. España )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MD Anderson International Spain SA
Study Sponsor  ICMJE MD Anderson International Spain SA
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: José F Tomas, MD MD Anderson Internacional España
PRS Account MD Anderson International Spain SA
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP