Clinical Trials Logo

Clinical Trial Summary

The goal of this clinical research study is to learn if lirilumab in combination with rituximab can help to control either CLL or Small lymphocytic lymphoma (SLL). The safety of the drug combination will also be studied.


Clinical Trial Description

Study Treatment:

Each study cycle is 28 days.

You will receive rituximab by vein over about 4-6 hours on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, you will receive rituximab on Day 1 of Cycles 2-12.

You will also receive lirilumab by vein over about 1 hour on Day 1 of each cycle.

Study Visits:

On Days 1, 8, 15, and 22 of Cycles 1 and 2 and then about every 2 weeks during Cycles 3-6:

- You will have a physical exam. You will not have this exam on Days 8 and 22 of Cycle 2.

- Blood (about 2 tablespoons) will be drawn for routine tests. If the doctor thinks it is needed, more blood may need to be drawn and you may need to have these tests performed more often. The study doctor will tell you if more blood will be drawn or if you will have this blood draw repeated.

On Day 1 of each cycle, if you can become pregnant, blood (about 1 tablespoon) or urine will be collected for a pregnancy test.

On Day 28 of Cycles 3 and 6:

- You will have physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests. This routine blood draw may include a pregnancy test if you can become pregnant. Urine may also be collected for this pregnancy test.

- You will have a bone marrow aspiration/biopsy to check the status of the disease.

- You will have a computerized tomography (CT) or positron emission tomography (PET) scan.

At least 1 time each month after Cycle 7:

- You will have physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

At least 1 time every 3 months after Cycle 7:

- Urine will be collected for routine tests. This routine urine collection will include a pregnancy test, if you can become pregnant. Blood (about 1 tablespoon) may also be drawn for this pregnancy test.

- You will have a bone marrow aspiration/biopsy to check the status of the disease.

- You will have a CT or PET scan.

Any time that the doctor thinks it is needed while you are on study, you will have blood draws, CT or PET scans, and/or bone marrow aspirations/biopsies to check the status of the disease and/or to monitor your health.

If the doctor thinks it is acceptable, you may be able to have some of these tests, such as routine blood and urine collections, performed at a local lab or clinic closer to your home. The results will be sent to the study doctor for review. Ask the study staff or study doctor about this possibility.

Length of Study:

You may receive up to 12 cycles of rituximab and up to 24 cycles of lirilumab. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after about 1 year of follow-up visits.

End-of-Study Visit:

Within 30 days after your last dose of study drug:

- You will have a physical exam.

- Blood (about 2-3 tablespoons) will be drawn for routine tests.

- If the doctor thinks it is needed, you will have a bone marrow aspirate to check the status of the disease.

- If the doctor thinks it is needed, you will have a CT or PET scan.

Follow-Up Visits:

After your end-of-study visit, you will have the following tests and procedures performed.

One (1) time each month for up to 1 year:

- You will have a physical exam.

- Blood (about 2-3 tablespoons) will be drawn for routine tests.

One (1) time every 3-6 months for up to 1 year, if the doctor thinks it is needed:

- You will have a bone marrow aspirate to check the status of the disease.

- You will have a CT scan or a PET scan.

If you start a new type of anticancer treatment during the year after your last dose of study drugs, you will stop having these follow-up visits.

This is an investigational study. Lirilumab is not FDA approved or commercially available. Rituximab is FDA approved and commercially available for the treatment of CLL. The use of these drugs in combination to treat CLL/SLL is considered investigational. The study doctor can explain how the drugs are designed to work.

Up to 48 participants will be enrolled in this study. All will take part at MD Anderson. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02481297
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date June 23, 2015
Completion date August 15, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05691608 - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 N/A
Recruiting NCT04092803 - Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu N/A
Active, not recruiting NCT02530463 - Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome Phase 2
Completed NCT00948064 - Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Phase 2
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Recruiting NCT03948529 - RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation Phase 2
Completed NCT01682226 - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies Phase 2
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Active, not recruiting NCT02723994 - A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia Phase 2
Terminated NCT02469415 - Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS) Phase 2
Recruiting NCT04856215 - 90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia Phase 2
Recruiting NCT06155188 - Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia N/A
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Completed NCT02910583 - Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL) Phase 2
Completed NCT01212926 - Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain N/A
Terminated NCT00014560 - Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Phase 1
Recruiting NCT04977024 - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer Phase 2
Recruiting NCT05866887 - Insomnia Prevention in Children With Acute Lymphoblastic Leukemia N/A