LeukemiaPhase 2NCT01490723
Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)
A Phase 2 study testing Rituximab, 111In Ibritumomab and Planar Scintigraphy Imaging in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan) to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine), followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of this combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Rituximab, 111In Ibritumomab and Planar Scintigraphy Imaging
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 24 Apr 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age.
- Patients with the following CD20+ lymphoid malignancies who are eligible for allogeneic transplantation: a. Relapsed or refractory follicular lymphoma; b. Relapsed or refractory or high risk mantle cell lymphoma (hi ki67; blastic); c. Recurrent or refractory marginal zone; d. Recurrent or refractory CLL/small lymphocytic lymphoma; e. Double-hit lymphoma; f. Diffuse large B cell lymphoma; g. Richter's patients; or h. Refractory or recurrent Burkitts.
- Patients who meet criterion #2 or have any of the following are eligible: a. Less than PR to salvage chemotherapy; b. Kinetic failure; c. Having received more than 3 lines of therapy; d. Failure to mobilize autologous stem cell; e. 10% or more marrow involvement; f. 6 months post autologous stem cell transplant.
- Patients must have a fully-matched related donor or a matched unrelated donor identified. Double cord (at least 4/6 matched) can be used if no adult matched donor is available.
- Performance score of at least 80% by Karnofsky or 0 to 2 ECOG.
- Left ventricular EF >/= 45% with no uncontrolled arrythmias or symptomatic heart disease.
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- FEV1, FVC >/= 60% and corrected DLCO >/= 60%.
- Serum creatinine </=1.6 mg/dL. Serum bilirubin < 2 mg/dL (unless due to Gilbert's Syndrome).
- SGPT < 2 X upper limit of normal.
- Men and women of reproductive potential must agree to follow accepted birth control methods (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Negative Beta HCG test within 30 days in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization). Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Who cannot join
- Patient with active CNS involvement with lymphoid malignancy.
- Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.
- Patients with other malignancies diagnosed within 2 years prior to study registration. Skin squamous or basal cell carcinoma are exceptions.
- Active bacterial, viral or fungal infections.
- History of stroke within 6 months prior to study registration.
- A prior allogeneic stem cell transplant.
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- Patient has received other investigational drugs within 3 weeks before study registration.
- Presence of circulating malignant lymphoid cells or bone marrow with lymphoma that constituted more than 25% of the cellular elements.
- Serious nonmalignant or malignant disease or psychiatric illness, which, in the opinion of the investigator would compromise protocol objectives or interfere with participation.
- Patients who are breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Dose-Intense Yttrium-90 Ibritumomab Tiuxetan (Zevalin)-Containing Non-Myeloablative Conditioning for Allogeneic Stem Cell Transplantation in B-cell Malignancies
The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan) to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine), followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of this combination will also be studied.
Two (2) forms of ibritumomab tiuxetan will be used in this study. 90Y-ibritumomab tiuxetan is designed to attach to lymphoma cells and destroy the cells using a radioactive particle that is attached to it. 111In-ibritumomab tiuxetan is like 90Y- ibritumomab tiuxetan, but the radioactive particle that is attached to it does not kill lymphoma cells. The radioactive particle makes the drug able to be seen inside your body. It is being used in this study to predict how fast the study drug will travel in the body and how long the drug stays in the body.
Read more
Rituximab is designed to attach to lymphoma cells, which may cause them to die.
Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.
Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Read the detailed description
Study Drug Administration and Procedures:
The chemotherapy, some of the other drugs in this study, and the stem cell transplant will be given by vein through your central venous catheter (CVC). A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia and will remain in your body during treatment. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form. Blood samples will also be drawn through the CVC.
On Days -22 (22 days before you receive the stem cell transplant), you will receive rituximab by vein over 3-4 hours. You will then receive 111In-ibritumomab tiuxetan by vein over 30 minutes.
From Day -22 through Day -16, you will have scans called whole-body planar scintigraphy imaging. In these scans, a special camera will capture 2-dimensional images of the whole body to see where the radioactive 111In- ibritumomab tiuxetan that was injected on Day -22 has spread. No additional radiation will be used in this scan. Scintigraphy will be performed right after the injection, then 3-6 hours after the injection, then 24, 72, and 144 hours (+/- 2 hours) after the injection.
After the last scintigraphy imaging scan, the scans will be reviewed to learn how much radiation has traveled to different organs and to decide how much 90Y- ibritumomab should be used.
On Day-14, you will receive rituximab by vein over 3-4 hours. You will then receive the calculated dose of 90Y-ibritumomab tiuxetan by vein over 30 minutes.
On Days -5, -4, and -3, you will receive fludarabine and bendamustine by vein over 1 hour each day.
On Days -3 through Day 100, if your stem cells are from cord blood, you will receive mycophenolate mofetil (MMF) by vein or by mouth. MMF is designed to block the donor cells from growing and spreading in a way that could cause graft versus host disease (GVHD -- a condition in which transplanted tissue attacks the recipient's body).
Starting on Day -2, if your stem cells are from a related or matched unrelated donor, you will receive tacrolimus by vein as a continuous (nonstop) infusion until you are able to take it by mouth to help prevent GVHD. You will then take tacrolimus by mouth 2 times a day for about 3 months. After that, your tacrolimus dose may be lowered if you do not have GVHD. Your doctor will discuss this with you.
On Days -2 and -1, if your stems cells are from a matched unrelated donor or from cord blood, you will receive thymoglobulin (ATG) by vein over about 4 hours. ATG is designed to weaken your immune system to reduce the risk of rejecting of the transplant.
On Day 0, you will receive the blood stem cells by vein over about 30-45 minutes. Blood (less than 1 teaspoon) will also be drawn to measure how much (if any) radiation from the 90Y- ibritumomab tiuxetan is left in the blood.
Starting on Day 0, if your stem cells are from cord blood, you will receive filgrastim (G-CSF) through a needle under the skin 1 time a day every day until your white blood count begins to recover. G-CSF is designed to help cells in the bone marrow to divide, which helps raise white blood cells counts more quickly, lower fever, and decrease the risk of infection.
On Days 1, 3, and 6, if your stem cells are from a related or matched unrelated donor, you will receive methotrexate over 30 minutes each day by vein to help prevent GVHD. Patients receiving a matched unrelated donor will also be given methotrexate on Day 11 after the transplant.
Starting on Day 7, if your stem cells are from a related or matched unrelated donor, you will receive G-CSF through a needle under the skin 1 time a day every day until your white blood count begins to recover.
When your doctor thinks they are needed, you will also receive antibiotics and antifungal drugs to help prevent and/or treat infections. Your doctor will tell you more about how these drugs are given and possible side effects.
You will be in the hospital for about 3-4 weeks after you receive the stem cell transplant. During this time, the following tests and procedures will be performed at any point that your doctor thinks they are needed:
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 4-6 teaspoons) will be collected for routine tests, to check your kidney and liver function, and to learn if and how well the transplant is working.
The following may also be performed if at any point the doctor thinks they are needed:
- You may have imaging scans to check the status of the disease and/or to check for possible infections.
- You may have a bone marrow biopsy to check the status of the disease. To collect a bone marrow biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a needle.
- You may have transfusions of blood and/or platelets.
You must stay in the Houston area for about 100 days after the stem cell transplant.
Long-Term Follow-Up:
About 3, 6, and 12 months after the stem cell transplant:
- Blood (about 6 teaspoons) will be collected for routine tests, to check kidney and liver function, and to see how well the transplant has taken.
- You will have CT and PET scans to check the status of the disease.
- You will have a bone marrow biopsy/aspirate to check the status of the disease.
About 2 and 3 years after the stem cell transplant, you will receive a phone call that will take less than 10 minutes to learn how you are doing.
Length of Study:
You will be on study for up to about 3 years. You may be taken off study early if the disease gets worse, if you have any intolerable side effects, of if you are unable to follow study directions.
You should talk to the study doctor if you want to leave the study early. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant doctor decides it is needed. It may be life-threatening to leave the study after you have begun to receive the study drugs but before you receive the stem cells.
This is an investigational study. Ibritumomab tiuxetan, rituximab, bendamustine, and fludarabine are FDA approved and commercially available for the treatment of lymphoma. The dose of ibritumomab tiuxetan in this study is designed to be higher than the FDA approved dose. The use of ibritumomab tiuxetan and bendamustine in combination with the other study drugs and a stem cell transplant for the treatment of lymphoma is investigational.
Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.
- Being tested
- Rituximab, 111In Ibritumomab, Planar Scintigraphy Imaging, 90Y IbritumomabTiuxetan, Fludarabine
- Keywords
- Leukemia, Chronic lymphocytic leukemia, Lymphoma, CD20+ lymphoid malignancies, Diffuse large B-cell lymphoma, Allogeneic transplantation, Rituximab, Rituxan, In ibritumomab, Y ibritumomab, Zevalin, Fludarabine Phosphate, Fludara, Bendamustine Hydrochloride, Bendamustine HCL, CEP-18083, SDX-105, Treanda, Stem Cell Transplantation, Planar Scintigraphy
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
250 mg/m2 by vein preceding 111In Ibritumomab and (90Y) ibritumomab tiuxetan administration, respectively on Days -22 and -14.
111In IbritumomabDrug
Also called Zevalin
(5.0 mCi +/- 10% of 111In) by vein immediately following the infusion of rituximab on Day -22.
Planar Scintigraphy ImagingProcedure or surgery
Day -22, -21 to -16: Planar scintigraphy whole-body imaging started on Day -22 post 111In Ibritumomab infusion prior to voiding, and repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Whole-body planar scintigraphy imaging will be repeated between 22-26 hours, then between 70-74 hours, and later between 142-146 hours post 111In Ibritumomab injection.
90Y IbritumomabTiuxetanDrug
Also called Zevalin
Calculated to deliver not below 10 Gy to normal organs (liver, lungs, kidneys) by vein post rituximab on Day -14.
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
30 mg/m2 intravenously on Days -5, -4, and -3.
BendamustineDrug
Also called Bendamustine Hydrochoride, Bendamustine HCL, CEP-18083, SDX-105
130 mg/m2 intravenously on D-5, -4 and -3.
ThymoglobulinDrug
Also called ATG, Antithymocyte Globulin
1 mg/kg (based on actual body weight) on Days -2 and -1 will be administrated to patients receiving a cord blood (CB) and a matched unrelated donor (MUD).
TacrolimusDrug
Also called Prograf
Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus is changed to oral dosing when tolerated and can be tapered off after day +90 if no Graft versus Host Disease (GVHD) is present.
For patients receiving cord blood (CB) graft, the Graft versus Host Disease (GvHD) prophylaxis will be with Tacrolimus. Tacrolimus will start on D-2 administrated at starting dose 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on D -2 and will be tapered around Day +180 if no GvHD is present.
MethotrexateDrug
5 mg/m2 by vein on Day +1, +3 and +6. Patients receiving an unrelated graft will also be given methotrexate on Day +11 after the transplant.
MycophenolateDrug
Also called MMF, Mycophenolate Mofetil, CellCept
15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth administered from Days -3 to +45 and then tapered to end by day 100 if there is no Graft versus Host Disease (GVHD).
G-CSFDrug
Also called Filgrastim, Neupogen
5 mcg/kg/day subcutaneously beginning Day +7 for patients receiving related and matched unrelated donor (MUD) grafts and on Day 0 for patients receiving a cord blood (CB). G-CSF will continue until the absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days.
Stem Cell TransplantationProcedure or surgery
Also called Allogeneic transplantation
Stem Cell Transplantation on Day 0
| Study group | Role | What they receive |
|---|---|---|
| Yttrium-90 Ibritumomab + Chemo | Experimental | Day -22 and -14, Rituximab 250 mg/m2 preceding 111In Ibritumomab and (90Y) ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14, (90Y) ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment. Receives: Drug: Rituximab; Drug: 111In Ibritumomab; Procedure: Planar Scintigraphy Imaging; Drug: 90Y IbritumomabTiuxetan; Drug: Fludarabine; Drug: Bendamustine; Drug: Thymoglobulin; Drug: Tacrolimus; Drug: Methotrexate; Drug: Mycophenolate; Drug: G-CSF; Procedure: Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Mortality (TRM)
Number of participants without treatment related mortality at day 100.
Measured: 100 days
Secondary outcomes (1)
Overall Survival (OS)
Percentage of participants alive at 3 years.
Measured: From date of treatment to date of relapse or death, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJan 2013
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Spectrum Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Issa F. Khouri, MD,BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490723
- Sponsor's protocol ID
- 2011-0393
- Other IDs
- NCI-2016-00250
- Status last verified
- Apr 2020
- First submitted
- 9 Dec 2011
- Last updated
- 5 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Intense Yttrium-90 Ibritumomab Tiuxetan (Zevalin)-Containing Non-Myeloablative Conditioning for Allogeneic Stem Cell Transplantation in B-cell Malignancies
- ClinicalTrials.gov ID
- NCT01490723
- Acronym / sponsor ID
- 2011-0393
- Keywords
- Leukemia, Chronic lymphocytic leukemia, Lymphoma, CD20+ lymphoid malignancies, Diffuse large B-cell lymphoma, Allogeneic transplantation, Rituximab, Rituxan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Spectrum Pharmaceuticals, Inc
- Study start
- Jan 2013 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Posted 5 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan) to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine), followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of this combination will also be studied.
Two (2) forms of ibritumomab tiuxetan will be used in this study. 90Y-ibritumomab tiuxetan is designed to attach to lymphoma cells and destroy the cells using a radioactive particle that is attached to it. 111In-ibritumomab tiuxetan is like 90Y- ibritumomab tiuxetan, but the radioactive particle that is attached to it does not kill lymphoma cells. The radioactive particle makes the drug able to be seen inside your body. It is being used in this study to predict how fast the study drug will travel in the body and how long the drug stays in the body.
Rituximab is designed to attach to lymphoma cells, which may cause them to die.
Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.
Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.
Detailed description
Study Drug Administration and Procedures:
The chemotherapy, some of the other drugs in this study, and the stem cell transplant will be given by vein through your central venous catheter (CVC). A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia and will remain in your body during treatment. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form. Blood samples will also be drawn through the CVC.
On Days -22 (22 days before you receive the stem cell transplant), you will receive rituximab by vein over 3-4 hours. You will then receive 111In-ibritumomab tiuxetan by vein over 30 minutes.
From Day -22 through Day -16, you will have scans called whole-body planar scintigraphy imaging. In these scans, a special camera will capture 2-dimensional images of the whole body to see where the radioactive 111In- ibritumomab tiuxetan that was injected on Day -22 has spread. No additional radiation will be used in this scan. Scintigraphy will be performed right after the injection, then 3-6 hours after the injection, then 24, 72, and 144 hours (+/- 2 hours) after the injection.
After the last scintigraphy imaging scan, the scans will be reviewed to learn how much radiation has traveled to different organs and to decide how much 90Y- ibritumomab should be used.
On Day-14, you will receive rituximab by vein over 3-4 hours. You will then receive the calculated dose of 90Y-ibritumomab tiuxetan by vein over 30 minutes.
On Days -5, -4, and -3, you will receive fludarabine and bendamustine by vein over 1 hour each day.
On Days -3 through Day 100, if your stem cells are from cord blood, you will receive mycophenolate mofetil (MMF) by vein or by mouth. MMF is designed to block the donor cells from growing and spreading in a way that could cause graft versus host disease (GVHD -- a condition in which transplanted tissue attacks the recipient's body).
Starting on Day -2, if your stem cells are from a related or matched unrelated donor, you will receive tacrolimus by vein as a continuous (nonstop) infusion until you are able to take it by mouth to help prevent GVHD. You will then take tacrolimus by mouth 2 times a day for about 3 months. After that, your tacrolimus dose may be lowered if you do not have GVHD. Your doctor will discuss this with you.
On Days -2 and -1, if your stems cells are from a matched unrelated donor or from cord blood, you will receive thymoglobulin (ATG) by vein over about 4 hours. ATG is designed to weaken your immune system to reduce the risk of rejecting of the transplant.
On Day 0, you will receive the blood stem cells by vein over about 30-45 minutes. Blood (less than 1 teaspoon) will also be drawn to measure how much (if any) radiation from the 90Y- ibritumomab tiuxetan is left in the blood.
Starting on Day 0, if your stem cells are from cord blood, you will receive filgrastim (G-CSF) through a needle under the skin 1 time a day every day until your white blood count begins to recover. G-CSF is designed to help cells in the bone marrow to divide, which helps raise white blood cells counts more quickly, lower fever, and decrease the risk of infection.
On Days 1, 3, and 6, if your stem cells are from a related or matched unrelated donor, you will receive methotrexate over 30 minutes each day by vein to help prevent GVHD. Patients receiving a matched unrelated donor will also be given methotrexate on Day 11 after the transplant.
Starting on Day 7, if your stem cells are from a related or matched unrelated donor, you will receive G-CSF through a needle under the skin 1 time a day every day until your white blood count begins to recover.
When your doctor thinks they are needed, you will also receive antibiotics and antifungal drugs to help prevent and/or treat infections. Your doctor will tell you more about how these drugs are given and possible side effects.
You will be in the hospital for about 3-4 weeks after you receive the stem cell transplant. During this time, the following tests and procedures will be performed at any point that your doctor thinks they are needed:
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will be asked about how you are feeling and about any side effects you may be having.
- Blood (about 4-6 teaspoons) will be collected for routine tests, to check your kidney and liver function, and to learn if and how well the transplant is working.
The following may also be performed if at any point the doctor thinks they are needed:
- You may have imaging scans to check the status of the disease and/or to check for possible infections.
- You may have a bone marrow biopsy to check the status of the disease. To collect a bone marrow biopsy, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a needle.
- You may have transfusions of blood and/or platelets.
You must stay in the Houston area for about 100 days after the stem cell transplant.
Long-Term Follow-Up:
About 3, 6, and 12 months after the stem cell transplant:
- Blood (about 6 teaspoons) will be collected for routine tests, to check kidney and liver function, and to see how well the transplant has taken.
- You will have CT and PET scans to check the status of the disease.
- You will have a bone marrow biopsy/aspirate to check the status of the disease.
About 2 and 3 years after the stem cell transplant, you will receive a phone call that will take less than 10 minutes to learn how you are doing.
Length of Study:
You will be on study for up to about 3 years. You may be taken off study early if the disease gets worse, if you have any intolerable side effects, of if you are unable to follow study directions.
You should talk to the study doctor if you want to leave the study early. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant doctor decides it is needed. It may be life-threatening to leave the study after you have begun to receive the study drugs but before you receive the stem cells.
This is an investigational study. Ibritumomab tiuxetan, rituximab, bendamustine, and fludarabine are FDA approved and commercially available for the treatment of lymphoma. The dose of ibritumomab tiuxetan in this study is designed to be higher than the FDA approved dose. The use of ibritumomab tiuxetan and bendamustine in combination with the other study drugs and a stem cell transplant for the treatment of lymphoma is investigational.
Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yttrium-90 Ibritumomab + Chemo | Experimental | Drug: Rituximab, Drug: 111In Ibritumomab, Procedure: Planar Scintigraphy Imaging, Drug: 90Y IbritumomabTiuxetan, Drug: Fludarabine, Drug: Bendamustine, Drug: Thymoglobulin, Drug: Tacrolimus, Drug: Methotrexate, Drug: Mycophenolate, Drug: G-CSF, Procedure: Stem Cell TransplantationDay -22 and -14, Rituximab 250 mg/m2 preceding 111In Ibritumomab and (90Y) ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14, (90Y) ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 to 70 years of age.
- Patients with the following CD20+ lymphoid malignancies who are eligible for allogeneic transplantation: a. Relapsed or refractory follicular lymphoma; b. Relapsed or refractory or high risk mantle cell lymphoma (hi ki67; blastic); c. Recurrent or refractory marginal zone; d. Recurrent or refractory CLL/small lymphocytic lymphoma; e. Double-hit lymphoma; f. Diffuse large B cell lymphoma; g. Richter's patients; or h. Refractory or recurrent Burkitts.
- Patients who meet criterion #2 or have any of the following are eligible: a. Less than PR to salvage chemotherapy; b. Kinetic failure; c. Having received more than 3 lines of therapy; d. Failure to mobilize autologous stem cell; e. 10% or more marrow involvement; f. 6 months post autologous stem cell transplant.
- Patients must have a fully-matched related donor or a matched unrelated donor identified. Double cord (at least 4/6 matched) can be used if no adult matched donor is available.
- Performance score of at least 80% by Karnofsky or 0 to 2 ECOG.
Key exclusion criteria (10 listed)
- Patient with active CNS involvement with lymphoid malignancy.
- Known infection with HIV, HTLV-I, Hepatitis B, or Hepatitis C.
- Patients with other malignancies diagnosed within 2 years prior to study registration. Skin squamous or basal cell carcinoma are exceptions.
- Active bacterial, viral or fungal infections.
- History of stroke within 6 months prior to study registration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: Rituxan250 mg/m2 by vein preceding 111In Ibritumomab and (90Y) ibritumomab tiuxetan administration, respectively on Days -22 and -14. | Drug | Yttrium-90 Ibritumomab + Chemo |
| 111In IbritumomabAlso: Zevalin(5.0 mCi +/- 10% of 111In) by vein immediately following the infusion of rituximab on Day -22. | Drug | Yttrium-90 Ibritumomab + Chemo |
| Planar Scintigraphy ImagingDay -22, -21 to -16: Planar scintigraphy whole-body imaging started on Day -22 post 111In Ibritumomab infusion prior to voiding, and repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Whole-body planar scintigraphy imaging will be repeated between 22-26 hours, then between 70-74 hours, and later between 142-146 hours post 111In Ibritumomab injection. | Procedure or surgery | Yttrium-90 Ibritumomab + Chemo |
| 90Y IbritumomabTiuxetanAlso: ZevalinCalculated to deliver not below 10 Gy to normal organs (liver, lungs, kidneys) by vein post rituximab on Day -14. | Drug | Yttrium-90 Ibritumomab + Chemo |
| FludarabineAlso: Fludarabine Phosphate, Fludara30 mg/m2 intravenously on Days -5, -4, and -3. | Drug | Yttrium-90 Ibritumomab + Chemo |
| BendamustineAlso: Bendamustine Hydrochoride, Bendamustine HCL, CEP-18083, SDX-105130 mg/m2 intravenously on D-5, -4 and -3. | Drug | Yttrium-90 Ibritumomab + Chemo |
| ThymoglobulinAlso: ATG, Antithymocyte Globulin1 mg/kg (based on actual body weight) on Days -2 and -1 will be administrated to patients receiving a cord blood (CB) and a matched unrelated donor (MUD). | Drug | Yttrium-90 Ibritumomab + Chemo |
| TacrolimusAlso: PrografStarting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus is changed to oral dosing when tolerated and can be tapered off after day +90 if no Graft versus Host Disease (GVHD) is present. For patients receiving cord blood (CB) graft, the Graft versus Host Disease (GvHD) prophylaxis will be with Tacrolimus. Tacrolimus will start on D-2 administrated at starting dose 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on D -2 and will be tapered around Day +180 if no GvHD is present. | Drug | Yttrium-90 Ibritumomab + Chemo |
| Methotrexate5 mg/m2 by vein on Day +1, +3 and +6. Patients receiving an unrelated graft will also be given methotrexate on Day +11 after the transplant. | Drug | Yttrium-90 Ibritumomab + Chemo |
| MycophenolateAlso: MMF, Mycophenolate Mofetil, CellCept15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth administered from Days -3 to +45 and then tapered to end by day 100 if there is no Graft versus Host Disease (GVHD). | Drug | Yttrium-90 Ibritumomab + Chemo |
| G-CSFAlso: Filgrastim, Neupogen5 mcg/kg/day subcutaneously beginning Day +7 for patients receiving related and matched unrelated donor (MUD) grafts and on Day 0 for patients receiving a cord blood (CB). G-CSF will continue until the absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days. | Drug | Yttrium-90 Ibritumomab + Chemo |
| Stem Cell TransplantationAlso: Allogeneic transplantationStem Cell Transplantation on Day 0 | Procedure or surgery | Yttrium-90 Ibritumomab + Chemo |
Primary outcome
Treatment-Related Mortality (TRM)
Time frame: 100 days
Number of participants without treatment related mortality at day 100.
1 secondary outcome
Overall Survival (OS)
Time frame: From date of treatment to date of relapse or death, up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Issa F. Khouri, MD,BS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, 111In Ibritumomab and Planar Scintigraphy Imaging in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Related Mortality (TRM) (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.