Phase II MOR00208 in Combination With Lenalidomide for Patients With Relapsed or Refractory CLL, SLL or PLL or Older Patients With Untreated CLL, SLL or PLL

NCT02005289 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: OSU-13031NCI-2013-02082
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well anti-cluster of differentiation (CD)19 monoclonal antibody MOR00208 and lenalidomide work in treating patients with relapsed, refractory, or previously untreated chronic lymphocytic leukemia, small lymphocytic lymphoma, or prolymphocytic leukemia. Monoclonal antibodies, such as anti-CD19 monoclonal antibody MOR00208, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-CD19 monoclonal antibody MOR00208 and lenalidomide may kill more cancer cells.

Conditions

Prolymphocytic Leukemia; Contiguous Stage II Small Lymphocytic Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage I Small Lymphocytic Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage III Small Lymphocytic Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Small Lymphocytic Lymphoma

Keywords

CLL; SLL; PLL; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Prolymphocytic Leukemia; MOR00208; MOR208

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieve a response (i.e. CR, complete response with incomplete recovery [CRi], nPR, or PR), as defined according to the IWCLL 2008 criteria

  Within each cohort, the proportion of patients who achieve an overall response will be estimated by the sum of the number of complete responses, complete responses with incomplete recovery, nodular partial responses, and partial responses divided by the total number of evaluable patients. Ninety percent exact binomial confidence intervals for the true overall response rate will be calculated for those patients included to evaluate the decision criteria.

  up to 6 months

Secondary Outcomes (15)

• ORR

  At 12 months

• PFS

  From the date of registration to date of relapse or death, assessed up to 12 months

• Time to next treatment

  From date of registration until date of next treatment or death, censoring those alive who have not started another treatment at last follow-up, assessed up to 12 months

• OS

  From date of registration until date of death or last follow-up, assessed up to 12 months

• Results of FISH

  Baseline

Study Arms (2)

Cohorts 1-3Treatment (MOR00208, lenalidomide)

EXPERIMENTAL

Patients receive anti-CD19 monoclonal antibody MOR00208 IV over 2 hours on day 1 (days 1, 2, 8, 15, and 22 of course 1 only) and lenalidomide PO daily on days 1-28 (days 9-28 of course 1 only). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Correlative studies will be collected for this trial and will focus on the effects of MOR00208 alone and in combination with lenalidomide on immune effector cell number and function.

Biological: MOR00208; Drug: lenalidomide; Other: Correlative Studies

Cohort 4 Treatment (MOR00208, ibrutinib)

EXPERIMENTAL

Patients receive anti-CD19 monoclonal antibody MOR00208 IV over 2 hours on day 1 (days 1, 2, 8, 15, and 22 of course 1 only) and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Correlative studies will be collected for this trial and will focus on the effects of MOR00208 alone and in combination with ibrutinib on immune effector cell number and function.

Biological: MOR00208; Other: Correlative Studies

Interventions

MOR00208 BIOLOGICAL

Given by IV infusion

Also known as: anti-CD19 MAb XmAb5574, anti-CD19 MoAb XmAb5574, XmAb5574

Cohort 4 Treatment (MOR00208, ibrutinib); Cohorts 1-3Treatment (MOR00208, lenalidomide)

lenalidomide DRUG

Given PO

Also known as: CC-5013, IMiD-1, Revlimid

Cohorts 1-3Treatment (MOR00208, lenalidomide)

Correlative Studies OTHER

Correlative studies associated with this trial will focus on the effects of MOR00208 alone and in combination with lenalidomide on immune effector cell number and function.

Also known as: laboratory biomarker analysis

Cohort 4 Treatment (MOR00208, ibrutinib); Cohorts 1-3Treatment (MOR00208, lenalidomide)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of intermediate or high risk CLL, SLL, or B cell (B)-PLL by Biennial International Workshop on CLL (IWCLL) 2008 criteria who have
• COHORT 1: previously untreated disease AND refuse or are ineligible for approved chemo- and/or -immunotherapy options for untreated CLL/SLL/PLL
• COHORT 2: previously received at least one therapy for their disease
• All patients must satisfy one of the following criteria for active disease requiring therapy:
• Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia)
• Massive (\>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
• Massive nodes (\>= 10 cm) or progressive or symptomatic lymphadenopathy
• Constitutional symptoms, which include any of the following:
• Unintentional weight loss of 10% or more within 6 months
• Significant fatigue limiting activity
• Fevers \>= 100.5 degrees Fahrenheit (F) for 2 weeks or more without evidence of infection
• Night sweats \> 1 month without evidence of infection
• Patients with a history of Richter's transformation are eligible if they now have evidence of CLL only, with \< 10% large cells in the bone marrow
• Creatinine =\< 2
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x upper limit of normal

You may not qualify if:

• Previous treatment with a CD19 antibody; prior lenalidomide is acceptable for patients on cohort 2
• Patients who have received alemtuzumab within the previous 6 months
• Patients with active Richter's transformation
• Patients with active graft versus host disease or active autoimmune condition related to CLL
• Female subject that is pregnant or breastfeeding; women of childbearing potential and men must agree to use adequate contraception prior to study entry, duration of study participation, and 30 days following study completion; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
• Patients with congestive heart failure in whom pre-treatment hydration would be prohibitive; New York Heart Association (NYHA) class III/IV congestive heart failure (CHF) is excluded
• Patients who have had treatment for CLL within 4 weeks, although palliative steroids are acceptable at doses =\< 20 mg prednisone daily
• Failure to recover from toxicity of previous radiotherapy or chemotherapy to grade 1
• Patients with active infections requiring IV antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection; patients on prophylactic antibiotics or antivirals are acceptable
• Patients with a known hypersensitivity to lenalidomide
• Patients who are known to be human immunodeficiency virus (HIV) or hepatitis C positive
• Patients who are known to have hepatitis B infection or who are hepatitis B core antibody or surface antigen positive; patients receiving prophylactic intravenous immunoglobulin (IVIG) may have false positive hepatitis serologies; patients who are on IVIG who have positive hepatitis serologies must have a negative hepatitis B deoxyribonucleic acid (DNA) to be eligible
• Patients with a history of prior malignancy other than CLL that requires active systemic therapy that will interfere with interpretation of efficacy or toxicity, or limit survival to 2 years; patients with basal or squamous skin carcinoma, cervical carcinoma in situ on biopsy, localized breast cancer requiring hormonal therapy or localized prostate cancer (Gleason score \< 5) are eligible
• Patients with substance abuse or other medical or psychiatric conditions that, in the opinion of the investigator, would confound study interpretation or affect the patient's ability to tolerate or complete the study

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• MorphoSys AG: collaborator

Study Sites (1)

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Leukemia, Prolymphocytic; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

tafasitamab; Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Jennifer Woyach, MD

  The Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: January 17, 2014
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)