CLINICAL TRIAL

Obinutuzumab for Leukemia

1 Prior Treatment
Refractory
Relapsed
Waitlist Available · 18+ · All Sexes · Rochester, NY

This study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL).

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About the trial for Leukemia

Eligible Conditions
Leukemia, Lymphocytic, Chronic, B-Cell · Leukemia · Chronic Lymphocytic Leukemia (CLL) · Leukemia, Lymphoid

Treatment Groups

This trial involves 3 different treatments. Obinutuzumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Obinutuzumab
DRUG
+
Ibrutinib
DRUG
Experimental Group 2
Obinutuzumab
DRUG
+
Ibrutinib
DRUG
Experimental Group 3
Obinutuzumab
DRUG
+
Ibrutinib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
FDA approved
Ibrutinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Evidence of progressive marrow failure with anemia (hemoglobin <11.0 g/L) and/or thrombocytopenia (platelets <100 x 10^9/L)
Massive (≥6 cm below the left costal margin), progressive, or symptomatic splenomegaly
Massive nodes (at least 10 cm longest diameter), progressive, or symptomatic lymphadenopathy
Progressive lymphocytosis with an increase of more than 50% over a 2-month period or LDT of <6 months.
Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids
unintentional weight loss >10% within 6 months prior to screening
significant fatigue (inability to work or perform usual activities) fevers >100.5° F or 38.0° C for 2 or more weeks prior to screening without evidence of infection
night sweats for more than 1 month prior to screening without evidence of infection
Relapsed after or refractory to at least one prior Chronic Lymphomcytic Leukemia-directed therapy
Age greater than or equal to 18 years
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 Years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 Years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 Years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Obinutuzumab will improve 1 primary outcome and 6 secondary outcomes in patients with Leukemia. Measurement will happen over the course of Baseline to 6 Months.

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
BASELINE TO 6 MONTHS
BASELINE TO 6 MONTHS
Complete Response Rate
6 MONTHS
6 MONTHS
Partial Response Rate
6 MONTHS
6 MONTHS
Minimal residual disease (MRD) status in the bone marrow and blood
6 MONTHS
6 MONTHS
Progression Free Survival
2 YEARS
2 YEARS
Overall Response Rate
2 YEARS
2 YEARS
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Who is running the study

Principal Investigator
M. S. D.
Matthew S. Davids, MD
Dana-Farber Cancer Institute

Patient Q & A Section

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

What are the signs of leukemia?

The signs and symptoms of leukemia include: fever, weight loss or loss of appetite, fatigue, blood in the urine, unexplained tiredness ("leukocytopenia"), shortness of breath ("dyspnea"), vomiting, easy bruising or bleeding and feeling that the bone marrow isn't working ("anemia") or is under the effect of chemotherapy ("leukopenia"). Symptoms usually manifest in a few weeks in the early disease stage, but most often occur later in the disease progression. Symptoms of leukemia may also differ over time, from patient to patient.

Anonymous Patient Answer

What is leukemia?

Leukemia is a disease in which white blood cells do not divide quickly enough to satisfy the body's demands. In leukemias, the white cells do not mature correctly into the cells and immune components that are needed to fight infection. Most leukemias are chronic. Typically, they cause feeling tired, frequent fever, swollen lymph glands and the breakdown of one or more parts of the bone marrow. Leukopenia is a term meaning a decrease in the number of white blood cells while neutropenia is a term meaning low neutrophil counts. Leukemias can also result in a low platelet count or thrombocytopenia.

Anonymous Patient Answer

Can leukemia be cured?

There is no evidence for a cure for leukemia, which has proven hard to treat. Nevertheless, it is a curable disease even if it is rare. The prognosis for a cured/recurrent or relapsed cancer without treatment is very poor.

Anonymous Patient Answer

What causes leukemia?

Leukemia can be caused by chromosomal abnormalities at different stages in the patient's life. Some mutations occur spontaneously, for example by acquiring a new mutation that alters cell proliferation and apoptosis rather than directly affecting the DNA, like the most common type of leukemia, AML. Some people develop leukemia as a side-effect of treatments they receive, and a mutation is the cause in about 5% of all cases. The underlying causes of ALL and HL are slightly different. Genetic disorders are an important cause of leukemias and other cancers in children. Leukemia is not a rare disease in childhood, a year of age to 14 years is when it occurs in children.

Anonymous Patient Answer

What are common treatments for leukemia?

For all types of leukemias, treatment generally consists of chemotherapy or targeted therapies. For chronic myeloid leukemia (CML) and acute myeloid leukemia, chemotherapy is used as the first-line therapy, and targeted therapies are used as alternative treatments. For acute lymphocytic leukemia (ALL), chemotherapy is generally the first line therapy.\n

Anonymous Patient Answer

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

Around 16,000 cases of leukemias are diagnosed each year in the United States, making it the most common cancer in US children and adults. The incidence of AML is 3 times larger in people with Down syndrome compared with the general US population.

Anonymous Patient Answer

Is obinutuzumab safe for people?

Obinutuzumab is well tolerated for people with relapsed/refractory MM. There was a moderate increase in grade 3 febrile events; however it is not clear whether they are the result of obinutuzumab therapy.

Anonymous Patient Answer

What are the latest developments in obinutuzumab for therapeutic use?

A phase II clinical trial published in 2017 showed that obinutuzumab with rituximab induces a complete or almost complete cytotoxicity in all patients with relapsed and refractory myeloid and B-cell malignancies. The authors recommend obinutuzumab with rituximab in the treatment of patients with relapsed and refractory myeloid and B-cell malignancies. The European Medicines Agency granted CE approval for obinutuzumab with rituximab for the treatment of relapsed and refractory multiple myeloma in 2018.

Anonymous Patient Answer

What is the survival rate for leukemia?

Survival has significantly improved in the United States and much of the population over time. This is because new treatment options have become available. The survival rate for AML is still around 25% and the survival for ALL around 60%.

Anonymous Patient Answer

How quickly does leukemia spread?

In a recent study, findings indicates that leukemia progresses through four clinical phases: the first phase, the second phase, the third phase, and the transition phase (Fig. 2). The second phase, in some cases, can be a prolonged phase, and it is conceivable that there is a window of opportunity for treatment. These observations may lead to the development of a more rational, personalized approach that uses chemotherapy to treat CML in the first phase, that may involve TKIs in the second phase, and targeted treatments in the third/transition phase of CML. In a recent study, findings provides a framework for clinicians and a new avenue for researchers alike to evaluate the timing and merits of targeted therapies that are being tested in clinical trials.

Anonymous Patient Answer

Have there been any new discoveries for treating leukemia?

“I was interested in learning about new methods of treatment because there are not many drugs on the market today that can treat cancer. If we could find something new, then that would be of benefit.” “If they can find something new for leukemia, what benefits it brings, if it can be used on a mass scale, that's something that we could benefit from. [...] We would love to see what kind of treatments are available for leukemia, because we think that's something that people could benefit from". “I think that's possible… but I think we (WWE) would be quite a tough team to find new ways to treat” “There are drugs in development for cancer...

Anonymous Patient Answer

What is obinutuzumab?

Obinutuzumab was well-tolerated. It was well tolerated, but it does seem to accumulate in cells after a long period of time, and also seems to accumulate in blood samples, but it may not be a biomarker of therapy response.

Anonymous Patient Answer
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