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LymphomaPhase 1/2NCT01538472

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

A Phase 1/2 study testing Y Zevalin, In Zevalin and Rituxan in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lymphoma
What is being tested?
Y Zevalin, In Zevalin and Rituxan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Sep 2003to Nov 2011
Phase
Phase 1/2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) (demonstrated in lymph nodes or bone marrow), chemosensitive (at least Partial Remission (PR)).
  • 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.
  • No prior radioimmunoconjugate therapy.
  • If patients had prior radiation, this should have not involved more than 25% of the bone marrow.
  • An IRB-approved signed informed consent.
  • Age: 18 to 65 years of age.
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  • 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.
  • Patients determined to have <10% bone marrow involvement with lymphoma within four weeks before stem cell collection as defined by bilateral aspirates and biopsies.
  • Prestudy performance status of 0, 1, or 2 according to the World Health Organization (WHO).
  • Female patients included must not be pregnant or lactating.
  • 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).
  • 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
  • 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.

Who cannot join

  • 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
  • Prior radioimmunotherapy.
  • Presence of central nervous system (CNS) lymphoma.
  • Patients with chronic lymphocytic lymphoma.
  • Patients with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related lymphoma.
  • Patients with abnormal liver function: total bilirubin > 1.5 mg/dl
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  • Patients with abnormal renal function: serum creatinine > 1.6 mg/dl
  • Patients who have received prior external beam radiation therapy to >25% of active bone marrow (involved field or regional).
  • Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
  • Corrected carbon monoxide diffusion in the lung (DLCO) <50% and forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 50% predicted.
  • Cardiac ejection fraction (EF) < 50% by 2-D Echogram.
  • Pleural effusions.
  • Prior radiation to lungs.
  • Abnormal cytogenetics, filter in situ hybridization (FISH) (-5, -7, 11q23)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Y Zevalin, BEAM and Rituximab In Autologous Stem Cell Transplantation (ASCT) For Lymphoma

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.

Read the detailed description

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
Lymphoma
Being tested
Y Zevalin, In Zevalin, Rituxan, BCNU, VP -16
Keywords
Lymphoma, Relapse B-cell CD20+ non-Hodgkin's lymphoma, High-dose BEAM chemotherapy, Y Zevalin, In Zevalin, Rituxan, Rituximab, BCNU, 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea, Carmustine, BiCNU, VP-16, Ara-C, Cytarabine, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride, Melphalan, Alkeran, G-CSF
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Y ZevalinDrug

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

  • In ZevalinDrug

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

  • RituxanDrug

    Also called Rituximab

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

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

  • BCNUDrug

    Also called Carmustine, BiCNU, 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea

    300 mg/m2 by vein on Day -6.

  • VP -16Drug

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

  • Ara-CDrug

    Also called Cytarabine, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride

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

  • MelphalanDrug

    Also called Alkeran

    140 mg/m2 by vein on Day -1.

  • Stem Cell InfusionProcedure or surgery

    Autologous stem cell infusion on Day 0.

  • G-CSFDrug

    Also called Filgrastim, Neupogen

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

Study groups in NCT01538472
Study groupRoleWhat they receive
Y Zevalin + BEAMExperimentalRituxan 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.
Receives: Drug: Y Zevalin; Drug: In Zevalin; Drug: Rituxan; Drug: BCNU; Drug: VP -16; Drug: Ara-C; Drug: Melphalan; Procedure: Stem Cell Infusion; Drug: G-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival Median

    Overall survival reported as number of days participants alive following treatment up to 5 years with annual follow up till disease progression. Evaluations done every 3 months for 1 year and then every 6 months for 5 years to check on the status of the disease, with long-term follow up as needed.

    Measured: Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration)

  2. 3-Year Overall Survival

    Number of participants alive 3 years following treatment. Evaluations done every 3 months for 1 year and then every 6 months to check on the status of the disease.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2012 (estimated)
  2. Study startSep 2003
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01538472
Sponsor's protocol ID
ID03-0123
Status last verified
Sep 2014
First submitted
20 Feb 2012
Last updated
11 Sep 2014
Data monitoring committee
No

Publications

  • Chamoun K, Milton DR, Ledesma C, Young KH, Jabbour EJ, Alatrash G, Anderlini P, Bashir Q, Ciurea SO, Marin D, Molldrem JJ, Olson AL, Oran B, Popat UR, Rondon G, Champlin RE, Gulbis AM, Khouri IF. Allogeneic Transplantation after Myeloablative Rituximab/BEAM +/- Bortezomib for Patients with Relapsed/Refractory Lymphoid Malignancies: 5-Year Follow-Up Results. Biol Blood Marrow Transplant. 2019 Jul;25(7):1347-1354. doi: 10.1016/j.bbmt.2019.02.022. Epub 2019 Mar 1.

    PubMed 30826465

  • Chahoud J, Sui D, Erwin WD, Gulbis AM, Korbling M, Zhang M, Ahmed S, Alatrash G, Anderlini P, Ciurea SO, Oran B, Fayad LE, Bassett RL Jr, Jabbour EJ, Medeiros LJ, Macapinlac HA, Young KH, Khouri IF. Updated Results of Rituximab Pre- and Post-BEAM with or without 90Yttrium Ibritumomab Tiuxetan during Autologous Transplant for Diffuse Large B-cell Lymphoma. Clin Cancer Res. 2018 May 15;24(10):2304-2311. doi: 10.1158/1078-0432.CCR-17-3561. Epub 2018 Feb 23.

    PubMed 29476021

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Y Zevalin, In Zevalin and Rituxan in people with 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 13 inclusion and 14 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 11 Sep 2014. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 11 Sep 2014). 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?

Overall Survival Median (time frame: Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01538472, which also lists 2 linked publications.

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 11 Sep 2014.

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