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LymphomaRituxan+BEAMNCT01702961

Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease

A study testing Melphalan, Ara-C and VP-16 in people with Lymphoma and Hodgkin's Disease, run by Baylor College of Medicine at 2 sites 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

High-dose chemotherapy followed by autologous (the patient's own) peripheral blood (circulating blood) stem cell (cells that divide to form white cells, red cells and cells that help clot) transplantation is a conventional treatment for patients with lymphoma (cancer of lymph glands) and Hodgkin's disease (cancer of… Read more about this study

Who is it for?
Any age
Conditions the study is for
Lymphoma, Hodgkin's Disease
What is being tested?
Melphalan, Ara-C and VP-16
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesUnited States
Study dates
Jun 2002to Jan 2017
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with biopsy-proven, relapsed, or refractory CD20+ lymphoma, or HD.
  • At least 2e6 CD34+/kg autologous PBSC stored. If patients are non-mobilizers, then at least 2e8 TNC/kg autologous marrow should be stored.
  • Patient is not pregnant.
  • Zubrod performance status less than or equal to 2.
  • Life expectancy is not severely limited by concomitant illness.
  • Left ventricular ejection fraction greater than or equal to 50%.
Show all 16Show fewer
  • No uncontrolled arrhythmias or symptomatic cardiac disease.
  • FEV1, FVC and DLCO greater than or equal to 50%.
  • No symptomatic pulmonary disease.
  • Serum creatinine less than or equal to 1.5 mg/dL.
  • Serum bilirubin less than or equal to 2X upper limit of normal, SGPT less than or equal to 3X upper limit of normal.
  • No evidence of chronic active hepatitis or cirrhosis.
  • No effusion or ascites greater than or equal to 1L prior to drainage.
  • HIV negative.
  • Patient or guardian able to sign informed consent.
  • Patients of any age may be enrolled on this protocol.

Who cannot join

  • Anyone not meeting the above criteria.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Texas Children's Hospital

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Current Practice Study of Rituxan in Patient Receiving BEAM Chemotherapy and Autologous Blood Stem Cell Transplantation for High Risk Lymphoma or Hodgkin's Disease

High-dose chemotherapy followed by autologous (the patient's own) peripheral blood (circulating blood) stem cell (cells that divide to form white cells, red cells and cells that help clot) transplantation is a conventional treatment for patients with lymphoma (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse (recurrence of disease). For patients who did not have a complete response after traditional chemotherapy, the chance is high that the tumor will return even after high-dose chemotherapy. To improve the response and decrease the chance of relapse, doctors have used rituximab, an antibody that kills lymphoma cells, both before and after transplantation. These doctors have reported that more patients had control of the tumor for an extended period of time using rituximab with high-dose chemotherapy with autologous stem cell transplantation. How widely this is applicable is not known.

The purpose of this clinical research trial is to confirm that there is a good control of tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional stem cell transplantation.

Read the detailed description

Subjects will receive the chemotherapy through a plastic tube (catheter) placed into a vein under the collarbone. The antibody rituximab is given on the day of admission. The subject will also start a six-day course of chemotherapy at that time. The chemotherapy will consist of the following drugs: BCNU, etoposide also called VP-16, Ara-C also called cytosine arabinoside, and melphalan. BCNU is given on the first day, Ara-C and VP-16 on the second, third, fourth and fifth days, and melphalan on the sixth day. The infusion of blood stem cells is given through the catheter the day after the last dose of chemotherapy. This is called Day 0. A week later the subject will receive shots under the skin of Neupogen to help the stem cells grow quickly. Three additional doses of rituximab are given weekly starting 2 weeks later. If the subject recovers and is discharged from the hospital before getting all the doses of rituximab, they can receive the remainder in clinic.

Patients will remain in the hospital for approximately 3-4 weeks, and in the Houston area for about 30 days from the infusion of the donor cells. The patient will have blood, urine, bone marrow, and x-ray examinations performed as necessary to monitor the results of treatment. They will have blood tests daily while hospitalized.

As an outpatient, the patient will be monitored to make sure their immune system (system in the body that helps protect the body and fights bacterial, viral and fungal infections) is recovering, and the patient may require additional infusions of immunoglobulins (infection-fighting blood proteins) until the blood protein levels are safe. The patient will also be taking antibiotic pills for about 6 months to prevent infections. They will have x-rays and other diagnostic tests (PET scans) every 6-12 months during the next 5 years to make sure the tumor stays under control.

Being tested
Melphalan, Ara-C, VP-16, BCNU, Rituxan
Keywords
Lymphoma, Hodgkin's Disease
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

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

  • MelphalanDrug

    Also called Alkeran

    Given on Day -1

    Melphalan is administered according to the current SOP.

  • Ara-CDrug

    Also called Cytarabine, Cytosar-u

    200 mg/m2 IB BID given on Days -5, -4, -3, -2

  • VP-16Drug

    Also called Etoposide

    200 mg/m2 IV BID given on Days -5, -4, -3, -2

  • BCNUDrug

    Also called Carmustine

    BCNU 300 mg/m2 IV given on Day -6

  • RituxanDrug

    Also called Rituxamib

    375 mg/m2 IB given on Days -6, +14, +21, +28

  • Stem CellsDrug

    Also called Autologous Blood Stem Cells

    Stem cells given on Day 0

Study groups in NCT01702961
Study groupRoleWhat they receive
BEAM+R: Autologous Stem Cell TransplantOtherAra-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells
Receives: Drug: Melphalan; Drug: Ara-C; Drug: VP-16; Drug: BCNU; Drug: Rituxan; Drug: Stem Cells

What is being measured

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

  1. Disease-free Survival

    Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas

    Measured: 12 months post-transplant

Secondary outcomes (2)

  1. Median Days to Neutrophil Engraftment

    Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.

    Measured: 30 days post-transplant

  2. Number of Participants With Overall Best Response Achieved After Transplantation

    Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.

    Measured: 3 months post-transplant

Timeline

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

  1. First posted10 Oct 2012 (estimated)
  2. Study startJun 2002
  3. Primary completionAug 2014
  4. Study completionJan 2017

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01702961
Sponsor's protocol ID
H-11892
Other IDs
Rituxan+BEAM
Acronym
Rituxan+BEAM
Status last verified
Nov 2018
First submitted
5 Oct 2012
Last updated
19 Dec 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Melphalan, Ara-C and VP-16 in people with Lymphoma and Hodgkin's Disease, run by Baylor College of Medicine at 2 sites 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 16 inclusion and 1 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2015). 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?

Disease-free Survival (time frame: 12 months post-transplant). 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 NCT01702961.

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 19 Dec 2018.

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