Lenalidomide and Rituximab in the Treatment of Relapsed Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma

NCT00294632 | Completed Phase 1 Results

• 2 other identifiers: 2005-0461NCI-2012-01356
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of the drug lenalidomide (Revlimid, lenalidomide) that can be given with Rituxan® (rituximab) in the treatment of relapsed mantle cell lymphoma. The safety and effectiveness of this combination treatment will also be studied in both mantle cell lymphoma and diffuse large B-cell non-Hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).

Conditions

Lymphoma

Keywords

Mantle Cell Lymphoma; B-Cell Non-Hodgkin's Lymphoma; Transformed Large Cell Lymphoma; Follicular Lymphoma; Lymphoma; MCL; Lenalidomide; CC-5013; Revlimid™; Rituximab; Rituxan

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With Rituximab

  MTD is defined as the highest dose level in which 1 or fewer participants experienced a dose limiting toxicity (DLT) in 6 participants treated. DLT is any grade III or IV toxicity during the first 28 days (first cycle) of therapy.

  28 days of cycle 1

Secondary Outcomes (2)

• Response of Participants Treated at Lenalidomide 20 mg

  56 days, assessed after 2 cycles

• Objective Response Rate of Participants Treated With Lenalidomide 20 mg: Overall Response as % of Participants With Complete or Partial Response

  56 days

Study Arms (1)

Lenalidomide + Rituximab

EXPERIMENTAL

Lenalidomide Starting Dose 10 mg oral daily on Days 1-21 + Rituximab 375 mg/m\^2 intravenous weekly for 4 weeks

Drug: Lenalidomide; Drug: Rituximab

Interventions

Lenalidomide DRUG

Starting Dose 10 mg By Mouth Daily on Days 1-21

Also known as: CC-5013, Revlimid™

Lenalidomide + Rituximab

Rituximab DRUG

375 mg/m\^2 By Vein Weekly for 4 Weeks

Also known as: Rituxan

Lenalidomide + Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I and Phase II: Confirmed diagnosis of mantle cell lymphoma with CD20 positivity in tissue biopsy. Patients must have previously treated relapsed and/or refractory MCL. Or for Phase II: Confirmed diagnosis of previously treated relapsed and/or refractory diffuse large B-cell lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).
• Understand and voluntarily sign an Institutional Review Board (IRB) approved informed consent form.
• Age equal to or greater than 18 years at the time of signing the informed consent.
• Patients must have bi-dimensional measurable disease (bone marrow only involvement is acceptable).
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
• Serum bilirubin \<1.5 mg/dl and serum creatinine \< 2.0 mg/dl; platelet count \>75,000/mm\^3 and absolute neutrophil count (ANC) \> 1,000/mm\^3. AST (SGOT) and ALT (SGPT) \< 2 x upper limit of normal or \< 5 x upper limit of normal if hepatic metastases are present.
• Disease free of prior malignancies of equal to or greater than 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy \> 3 years.
• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test 10-14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide.
• Continuation from # 8 : (HIGHLY EFFECTIVE METHODS - Intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation, partner's vasectomy. ADDITIONAL EFFECTIVE METHOD-latex condom, diaphragm, cervical cap) while on study drug.
• WCBP must agree to have pregnancy tests every week for the first 4 weeks of treatment, then every 4 weeks if her menstrual cycles are regular or every 2 weeks if her cycles are irregular, while on study drug, and 4 weeks after the last dose of study drug. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
• Patients may have 1 to 4 lines of prior therapy for MCL (projected median 2 prior lines of therapy). Patient may or may not have received an anthracycline-based chemotherapy regimen.
• Patients must be willing to receive transfusions of blood products.
• Past stem cell (autologous or allogenic) transplantation is acceptable.
• Patients may have prior therapy with rituximab.

You may not qualify if:

• Any serious medical condition including but not limited to, uncontrolled hypertension, diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), renal failure, active infection, active hemorrhage, laboratory abnormality, or psychiatric illness that places the patient at unacceptable risk and would prevent the subject from signing the informed consent form. Patients with history of cardiac arrythmias should have cardiac evaluation and clearance.
• Pregnant or lactating females.
• Use of any standard/experimental anti-lymphoma drug therapy, including steroids, within 3 weeks of initiation of the study or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of initiation of the study drug treatment.
• Known hypersensitivity to thalidomide or rituximab; including the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide.
• Prior use of lenalidomide.
• Known HIV infection. Patients with active hepatitis B infection (not including patients with prior hepatitis B vaccination; not including patients with positive serum Hepatitis B antibody). Known hepatitis C infection is allowed as long as there is no active disease and is cleared by GI consultation.
• All patients with history of central nervous system lymphoma.
• Patients with peripheral blood involvement with white blood cell count (WBC) \> 20,000 are EXCLUDED for the Phase I component of the study.
• Patients with \>/= Grade 3 neuropathy.
• Patients with active pulmonary embolism or deep vein thrombosis (30 days within diagnosis).
• Patients with severe bradycardia (heart rate \<40 bpm, hypotension, light-headedness, syncope).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Wang M, Fayad L, Wagner-Bartak N, Zhang L, Hagemeister F, Neelapu SS, Samaniego F, McLaughlin P, Fanale M, Younes A, Cabanillas F, Fowler N, Newberry KJ, Sun L, Young KH, Champlin R, Kwak L, Feng L, Badillo M, Bejarano M, Hartig K, Chen W, Chen Y, Byrne C, Bell N, Zeldis J, Romaguera J. Lenalidomide in combination with rituximab for patients with relapsed or refractory mantle-cell lymphoma: a phase 1/2 clinical trial. Lancet Oncol. 2012 Jul;13(7):716-23. doi: 10.1016/S1470-2045(12)70200-0. Epub 2012 Jun 6.

  PMID: 22677155 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell; Lymphoma, B-Cell; Lymphoma, Follicular

Interventions

Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Michael Wang, Professor, Lymphoma/Myeloma
• Organization: The University of Texas (UT) MD Anderson Cancer Center

miwang@mdanderson.org

713-792-2860

Study Officials

• Michael Wang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2006
• First Posted: February 22, 2006
• Study Start: February 1, 2006
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Locations

US (1)