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Trial record 52 of 179 for:    LENALIDOMIDE AND Leukemia

Lenalidomide and Obinutuzumab in Treating Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT02225275
Recruitment Status : Active, not recruiting
First Posted : August 26, 2014
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies how well lenalidomide and obinutuzumab work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and obinutuzumab may work better in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Condition or disease Intervention/treatment Phase
Recurrent Chronic Lymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Small Lymphocytic Lymphoma Drug: Lenalidomide Biological: Obinutuzumab Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Overall response defined as achievement of complete response (CR) or partial response (PR).

SECONDARY OBJECTIVES:

I. Safety of the combination. II. Response according to prognostic markers at diagnosis. III. Time to next treatment. IV. Overall survival.

OUTLINE:

Patients receive obinutuzumab intravenously (IV) over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide orally (PO) once daily (QD) on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Lenalidomide and Obinutuzumab (GA101) in Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Actual Study Start Date : March 31, 2016
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023


Arm Intervention/treatment
Experimental: Treatment (lenalidomide, obinutuzumab)
Patients receive obinutuzumab IV over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide PO QD on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment with obinutuzumab repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity.
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid

Biological: Obinutuzumab
Given IV
Other Names:
  • Anti-CD20 Monoclonal Antibody R7159
  • GA-101
  • GA101
  • Gazyva
  • huMAB(CD20)
  • R7159
  • RO 5072759




Primary Outcome Measures :
  1. Overall response (OR) [ Time Frame: Up to 7 years ]
    OR will be defined as complete or partial response. The proportion of patients achieving OR and its 95% credible interval will be presented.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 7 years ]
    The futility and safety of the treatment combination will be monitored using a Bayesian design by Thall, Simon and Estey.

  2. Response according to prognostic markers [ Time Frame: At diagnosis ]
    Univariate and multivariable logistic regression models will be fit to assess the association between OR and prognostic biomarkers.

  3. Time to next treatment [ Time Frame: Up to 7 years ]
    The time-to-event outcomes (such as time to next treatment or overall survival) will be estimated using the Kaplan-Meier method.

  4. Overall survival [ Time Frame: Up to 7 years ]
    The time-to-event outcomes (such as time to next treatment or overall survival) will be estimated using the Kaplan-Meier method.



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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:

  • Able to understand and to provide voluntarily informed consent
  • Have documented chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to National Cancer Institute (NCI) criteria
  • Recurrent or refractory disease according to NCI criteria
  • Patient are eligible if they have received one or more prior treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy > 6 months
  • Serum creatinine less or equal to 2 mg/dl
  • Total bilirubin less or equal to 2 mg/dl
  • Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) less or equal to two times the upper normal limit
  • Disease free of prior malignancies for 3 years with exception of currently treated basal cell squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast; patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received
  • No prior history of myelodysplastic syndrome or other myeloid malignancy
  • All participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the Revlimid REMS
  • Females of childbearing potential (FCBP) must have a negative serum and/or urine pregnancy test with a sensitive of at least 50 mIU/mL within 10-14 days and again within 24 hours prior to prescribe lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy

Exclusion Criteria:

  • Known sensitivity to lenalidomide or other thalidomide derivatives or anti cluster of differentiation (CD)20
  • Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood)
  • Known history of infection with human immunodeficiency virus (HIV) or human T cell leukemia virus 1 (HTLV-1)
  • Serologic status reflecting active hepatitis B or C; patients with hepatitis B (HBV) antibody positive but who have positivity for hepatitis B surface antigen (HBsAg) or anti hepatitis B core antibody (anti-HBc) and patients who are positive for anti-hepatitis C (HCV) will need to have a negative polymerase chain reaction (PCR) (viral HBV deoxyribonucleic acid [DNA] or HCV ribonucleic acid [RNA]) result prior to enrollment; those who are HBsAg positive or HBV DNA positive and those who are positive for HCV (RNA) will be excluded
  • Pregnant or breast feeding females
  • History of tuberculosis treated within the last five years or recent exposure to tuberculosis
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject unacceptable risk if he/she were to participate to the study
  • Patients with a recent history of deep vein thrombosis or pulmonary embolus, in the six months prior to enrollment are not eligible for this study

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): NCT02225275


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alessandra Ferrajoli M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02225275     History of Changes
Other Study ID Numbers: 2014-0115
NCI-2015-00237 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0115 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lenalidomide
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Obinutuzumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Immunological