MOR00208 for Stage IV Small Lymphocytic Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
The Ohio State University Comprehensive Cancer Center, Columbus, OH
Stage IV Small Lymphocytic Lymphoma+16 More
MOR00208 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether anti-CD19 monoclonal antibody MOR00208 and lenalidomide work in treating patients with relapsed, refractory, or previously untreated chronic lymphocytic leukemia, small lymphocytic lymphoma,

See full description

Eligible Conditions

  • Stage IV Small Lymphocytic Lymphoma
  • Stage I Small Lymphocytic Lymphoma
  • Stage III Chronic Lymphocytic Leukemia
  • Prolymphocytic Leukaemia (PLL)
  • Recurrent Small Lymphocytic Lymphoma
  • Stage I Chronic Lymphocytic Leukemia
  • Contiguous Stage II Small Lymphocytic Lymphoma
  • Noncontiguous Stage II Small Lymphocytic Lymphoma
  • Stage III Small Lymphocytic Lymphoma
  • Chronic Lymphocytic Leukemia (CLL) - Refractory
  • Stage II Chronic Lymphocytic Leukemia
  • Stage IV Chronic Lymphocytic Leukemia

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether MOR00208 will improve 1 primary outcome and 15 secondary outcomes in patients with Stage IV Small Lymphocytic Lymphoma. Measurement will happen over the course of Baseline.

At 12 months
ORR
Baseline
IgVH mutational status
Results of FISH
Results of stimulated karyotype
Zap-70 methylation
Month 12
Changes in IL-21R expression
Month 12
Changes in expression of select genes associated with B-cell activation
Month 12
OS
Month 12
Time to next treatment
Month 12
PFS
Up to 12 months
Effects of combined therapy with MOR00208 and lenalidomide on CD4+ T cells using flow cytometry during the course of protocol therapy
Effects of combined therapy with MOR00208 and lenalidomide on CD8+ T cells during the course of protocol therapy by flow cytometry
Effects of combined therapy with MOR00208 and lenalidomide on NK cells during the course of protocol therapy by flow cytometry
Incidence of adverse events as graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Tolerability assessed by the number of patients who require dose modifications and/or dose delays
up to 6 months
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

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Cohorts 1-3Treatment (MOR00208, lenalidomide)
1 of 2
Cohort 4 Treatment (MOR00208, ibrutinib)
1 of 2
Experimental Treatment

This trial requires 41 total participants across 2 different treatment groups

This trial involves 2 different treatments. MOR00208 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cohorts 1-3Treatment (MOR00208, lenalidomide)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.
Cohort 4 Treatment (MOR00208, ibrutinib)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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 12 months for reporting.

Who is running the study

Principal Investigator
J. W.
Jennifer Woyach, Principal Investigator
Ohio State University Comprehensive Cancer Center

Closest Location

The Ohio State University Comprehensive Cancer Center - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Stage IV Small Lymphocytic Lymphoma or one of the other 16 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
COHORT 1: never received any therapies for their disease COHORT 2 patients are those who have received at least one therapy for their disease, while COHORT 1 patients have never received any therapies for their disease. show original
not had chemotherapy should consider 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 not had chemotherapy should consider treatment with ibrutinib. show original
The first cohort consists of people who have a previously untreated disease and who refuse or are ineligible for approved chemo- and/or immunotherapy options for untreated CLL/SLL/PLL. show original
The development of anemia or thrombocytopenia that can't be explained by autoimmune hemolytic anemia or thrombocytopenia may be a sign of marrow failure. show original
Massive (>= 6 cm below the costal margin), progressive or symptomatic splenomegaly
Massive nodes (>= 10 cm) or progressive or symptomatic lymphadenopathy
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
The individual has night sweats that have been present for more than a month and there is no evidence of infection. show original

Patient Q&A Section

What are the signs of leukemia, prolymphocytic?

"The signs of prolymphocytic leukemia are similar to B-cell lymphoblastic lymphoma, but prolymphocytic leukemia can often progress to B-cell lymphosarcoma. Prolymphocytic leukemia should be distinguished from lymphoid malignancy." - Anonymous Online Contributor

Unverified Answer

Can leukemia, prolymphocytic be cured?

"Leukemia, prolymphocytic and B-CLL cannot be cured. However, some patients can have remission for decades; long-term remission is rarely obtained. Long-term survival varies because many patients have late disease recurrences that can be fatal." - Anonymous Online Contributor

Unverified Answer

What is leukemia, prolymphocytic?

"Leukemia and prolymphocytic illness, especially acute myelogenous leukemia, are diseases that can cause sudden bleeding and bruising as an indicator of high leukocyte count. These illnesses also affect one's body immunity." - Anonymous Online Contributor

Unverified Answer

What causes leukemia, prolymphocytic?

"Leukemia and prolymphocytic diseases occur when hematopoietic cells fail to mature and behave normally. These diseases are characterized by the accumulation of leukemic cells and prolymphocytic cells in the lymphatic system, bone marrow, and other sites. The underlying causes of leukemia and prolymphocytic diseases vary, but generally involve a combination of genetic, immunologic, environmental, and possibly occupational influences." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia, prolymphocytic a year in the United States?

"1.7 million people will develop leukemia in the U.S. over the next year. In the first instance, leukemia will be more common among African Americans, but by the end of the first year, they will comprise the majority of reported cases." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia, prolymphocytic?

"The therapeutic approach is basically that of chronic myelogenous leukemia (CML) and chronic lymphocytic leukemia (CLL). Both have been cured of myelosis or lymphocytosis by standard chemotherapy, particularly by chemotherapy regimens containing anthracycline, a purine analogue, or a nitrogen mustard drug. In addition, CLL and CML both respond well to newer targeted therapy. Prognosis in both CML and CLL is variable. In some patients, the disease progresses rapidly; in others, the disease is extremely long-lasting. The survival of patients with chronic myelogenous leukemia is estimated to be 7.0 to 10.0 years from diagnosis." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating leukemia, prolymphocytic?

"Our group has continued to study various aspects of leukemia such as [drug resistance, development of secondary tumors, and other factors involved in leukemia development and pathogenesis(https://clinicaltrials.gov/ct2/show/NCT00236939?term = leukemia&term2 = prolymphocytic). Furthermore, [power] offers easy ways to search recent trials for leukemias and their treatment by condition, treatment, or location." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia, prolymphocytic?

"There is good evidence that therapy with azacitidine in high-risk myelodysplastic syndrome and in chronic myelogenous leukemia has improved survival over last decade. There is low quality evidence that alemtuzumab, in combination with dasatinib, may improve the survival of newly diagnosed patients with myelodysplastic syndrome progressing from myelodysplastic syndromes, while there is no evidence it improves survival in chronic myelogenous leukemia patients with blast crisis." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for leukemia, prolymphocytic?

"Overall survival of prolymphocytic leukemia is about 60%. However, it is slightly higher than that of leukemia without prolymphocytic features. It is important to get a detailed understanding of the features of leukemia when diagnosing; because there are few known features which can increase the life expectancy of patients suffering from prolymphocytic leukemia." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving mor00208?

"(i) Data from a recent study here reported, although not directly compared to other agents, suggests the interest of such clinical evaluation of mor00208. (ii) Clinically insignificant side effects were noted in our study and were typical of other therapeutic trials. (iii) Mor00208 is a promising new agent, with potential clinical impact that deserves clinical evaluation." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for leukemia, prolymphocytic?

"In this review, the authors discuss the value of clinical trials for all subtypes of leukemia and all stages of prolymphocytic leukemia, and provide guidelines on which type of patients to consider clinical trial involvement and in which trials to consider for which patients. They illustrate these by discussing the benefit and risks of clinical trials using the FDA investigational new drug (IND) pathway in patients with chronic lymphocytic leukemia ( CLL ) who do not have a mutated IGHV, one of the genetic mutations that is found in most patients with CLL, are in the relapsing or the early stages of follicular lymphoma ( FL ), and are in the relapsing phase in chronic lymphocytic leukemia (CLL)." - Anonymous Online Contributor

Unverified Answer

How serious can leukemia, prolymphocytic be?

"Leukemias can have unpredictable and deadly effects on patients with or without treatment. Leukemia can be diagnosed either in children or adults. There is no doubt about leukemia being deadly and the way it reacts to treatment can be unpredictable. There are many factors, such as treatments chosen, the time of diagnosis, as well as the stage and progression of the disease that affect a patient’s survival. There are many types of Leukemia. You could be diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia or chronic myeloid leukemia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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