Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical research study is to see if high-dose chemotherapy (BEAM) and rituximab, given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells is safe. Another goal is to learn if this treatment can help decrease the chances of the cancer coming back.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab in Autologous Stem Cell Transplantation

NCT00591630

Diffuse Large Cell Lymphoma Lymphoma

COMPLETED PHASE2

Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma

NCT00438581

Non-Hodgkin's Lymphoma

UNKNOWN PHASE2

Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma

NCT00689169

Lymphoma, Large Cell, Diffuse

COMPLETED PHASE2

Zevalin With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Non Hodgkin Lymphoma

NCT00807196

Non-Hodgkins Lymphoma

UNKNOWN PHASE1/PHASE2

Yttrium-90 Ibritumomab Tiuxetan (Zevalin) With BEAM in Relapsed Low Grade B-Cell Lymphoma

NCT00138086

B-Cell Lymphoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

BEAM chemotherapy is the standard treatment for lymphoma. BEAM is a combination of chemotherapy drugs (carmustine, cytarabine, etoposide, and melphalan). Rituximab is an antibody made from human and mouse proteins. It reacts with a certain molecule on the surface of lymphoma cells and helps the body's immune system destroy the lymphoma cells. 90Y Zevalin is also an antibody made from mouse proteins. However, it has a particle of radiation attached to it. 90Y Zevalin works by attaching to lymphoma cells, and the radiation particle destroys the lymphoma cell.

For this study, you will receive rituximab by vein followed by a dose of 111In Zevalin by vein (over 15 minutes). 111In Zevalin is different from the study drug (90Y Zevalin). 111In Zevalin has a different type of radioactive particle attached to it. This particle does not kill lymphoma cells, but it can be "seen" inside the body using a special camera (like an x-ray). 111In Zevalin is being used to predict how fast the study drug will travel in the body and how long the drug stays in the body. Doctors need to be able to see how much of the drug goes to the tumor and how much goes to normal organs to determine if it is safe to give 90Y Zevalin on an outpatient basis. A scan will be done as soon as 111In Zevalin is given and about 2-24 hours later. Scans will also be done 2-3 days later. If the radiation in the 111In Zevalin is not a threat to normal organs and bone marrow, you may receive 90Y Zevalin. Seven (7) days after the 111In Zevalin injection, you will receive a second dose of rituximab followed by a dose of 90Y Zevalin by vein (over 15 minutes).

Seven (7) days after the 90Y Zevalin injection, you will receive the BEAM combination of chemotherapy. You will receive carmustine (over 2 hours) on Day 1 of chemotherapy. You will receive cytarabine (over 2 hours) followed by etoposide (over 4 hours) twice a day on Days 2 through 5. On Day 6, you will receive melphalan (over 20 minutes). A catheter (small flexible tube) will be placed in a large vein in your chest so that the chemotherapy drugs can be given to you more easily. This is called a central venous catheter. All of the chemotherapy drugs will be given through the central venous catheter.

One day after finishing the chemotherapy, the stem cells that were collected earlier will be given back to you by vein over about 30 minutes. Starting on the same day, you will receive treatments with G-CSF by injection under the skin once a day. Treatment with G-CSF will continue until your blood counts reach a certain level.

You will receive rituximab by vein (over 6 to 8 hours) on the day after the transplant and again 1-week later.

Blood tests (about 1-2 tablespoons), urine tests, bone marrow collections, and x-rays will be done as needed to track the effects of the transplant. You will have transfusions of blood and platelets as needed. Blood tests (about 1 tablespoon) will be done once a day while you are in the hospital.

Blood tests (about 1-2 tablespoons), urine tests, bone marrow collections, x-rays, CT scans, and PET scans will be done every 3 months for 1 year and then every 6 months for 5 years to check on the status of the disease.

You will be asked to give some extra blood samples (around 1 tablespoon each) at study entry and upon return visits to M. D. Anderson. These samples will be used to test for certain molecules in the blood (HAMA and soluble CD20) and to check on the level of rituximab in the blood.

Treatment will be given in the hospital at the University of Texas (UT) MD Anderson. You will need to stay in the hospital for about 3 to 4 weeks. You should stay in the Houston area for about 2 to 4 weeks after the transplant. After that, you will need to return to Houston from time to time for blood tests, urine tests, and other exams.

This is an investigational study. This is an investigational study. 90Y-Zevalin is approved by the FDA for relapsed and refractory lymphoma. Its use in this trial, however, is investigational. All other drugs used in this study are FDA approved and are commercially available. Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Y Zevalin + BEAM

Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.

G-CSF 5 mg/kg given daily starting Day 0 till recovery of granulocytes of 4.0 \* 109/L.

Group Type EXPERIMENTAL

Y Zevalin

Intervention Type DRUG

Starting dose: 0.4 mCi/kg by vein after Rituxan infusion on Day -14.

In Zevalin

Intervention Type DRUG

Imaging dose: 5 mCi by vein following Rituxan infusion on Day -21.

Rituxan

Intervention Type DRUG

250 mg/m2 by vein on Day -21 and on Day -14.

1000 mg/m2 by vein on Days +1 and +8.

BCNU

Intervention Type DRUG

300 mg/m2 by vein on Day -6.

VP -16

Intervention Type DRUG

200 mg/m2 by vein every 12 hours on Days -5, -4, -3, and -2.

Ara-C

Intervention Type DRUG

200 mg/m2 by vein every 12 hours on Days -5, -4, -3,and -2.

Melphalan

Intervention Type DRUG

140 mg/m2 by vein on Day -1.

Stem Cell Infusion

Intervention Type PROCEDURE

Autologous stem cell infusion on Day 0.

G-CSF

Intervention Type DRUG

5 mg/kg by vein daily starting Day 0 till recovery of granulocytes of 4.0 x 109/L.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Y Zevalin

Starting dose: 0.4 mCi/kg by vein after Rituxan infusion on Day -14.

Intervention Type DRUG

In Zevalin

Imaging dose: 5 mCi by vein following Rituxan infusion on Day -21.

Intervention Type DRUG

Rituxan

250 mg/m2 by vein on Day -21 and on Day -14.

1000 mg/m2 by vein on Days +1 and +8.

Intervention Type DRUG

BCNU

300 mg/m2 by vein on Day -6.

Intervention Type DRUG

VP -16

200 mg/m2 by vein every 12 hours on Days -5, -4, -3, and -2.

Intervention Type DRUG

Ara-C

200 mg/m2 by vein every 12 hours on Days -5, -4, -3,and -2.

Intervention Type DRUG

Melphalan

140 mg/m2 by vein on Day -1.

Intervention Type DRUG

Stem Cell Infusion

Autologous stem cell infusion on Day 0.

Intervention Type PROCEDURE

G-CSF

5 mg/kg by vein daily starting Day 0 till recovery of granulocytes of 4.0 x 109/L.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rituximab Carmustine BiCNU 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea Cytarabine Cytosar DepoCyt Cytosine Arabinosine Hydrochloride Alkeran Filgrastim Neupogen

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Relapsed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) (demonstrated in lymph nodes or bone marrow), chemosensitive (at least Partial Remission (PR)).
2. No anti-cancer therapy started within three weeks, prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy. No prior Rituximab within three weeks of starting therapy.
3. No prior radioimmunoconjugate therapy.
4. If patients had prior radiation, this should have not involved more than 25% of the bone marrow.
5. An IRB-approved signed informed consent.
6. Age: 18 to 65 years of age.
7. Acceptable hematologic status within two weeks prior to patient registration, including: Absolute neutrophil count (\[segmented neutrophils + bands\] \* total white blood count (WBC)) \> 1,500/mm3. Platelet counts \> 100,000/mm3.
8. Patients determined to have \<10% bone marrow involvement with lymphoma within four weeks before stem cell collection as defined by bilateral aspirates and biopsies.
9. Prestudy performance status of 0, 1, or 2 according to the World Health Organization (WHO).
10. Female patients included must not be pregnant or lactating.
11. Men and women or reproductive potential who are following acceptable birth control methods (as determined by the treating physician, however abstinence is not an acceptable method).
12. Patients who have previously been treated on Phase II drugs can be included if no long-term toxicity is expected, and the patient has been off the drug for four or more weeks with no significant post treatment toxicities observed
13. Patients should have at least 4 \* 106 CD34+/kg peripheral stem cells collected. Whenever possible, 1 to 2 \* 106 CD34+/kg, for the first 10 patients and held for 1 year in case of graft failure. If graft failure does not occur in the first 10 patients, backup cells will not be required for subsequent patients.

Exclusion Criteria

1. Patients with impaired bone marrow reserve, as indicated by one or more of the following: Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue Platelet count \< 100,000 cells/mm3 Hypocellular bone marrow Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid) History of failed stem cell collection of \> 4\*106 CD34+/kg
2. Prior radioimmunotherapy.
3. Presence of central nervous system (CNS) lymphoma.
4. Patients with chronic lymphocytic lymphoma.
5. Patients with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related lymphoma.
6. Patients with abnormal liver function: total bilirubin \> 1.5 mg/dl
7. Patients with abnormal renal function: serum creatinine \> 1.6 mg/dl
8. Patients who have received prior external beam radiation therapy to \>25% of active bone marrow (involved field or regional).
9. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
10. Corrected carbon monoxide diffusion in the lung (DLCO) \<50% and forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) \< 50% predicted.
11. Cardiac ejection fraction (EF) \< 50% by 2-D Echogram.
12. Pleural effusions.
13. Prior radiation to lungs.
14. Abnormal cytogenetics, filter in situ hybridization (FISH) (-5, -7, 11q23)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No