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LymphomaPhase 1NCT00574509

Hematopoietic Stem Cell Transplant for Recurrent Non-Hodgkin's Lymphoma

A Phase 1 study testing 131Iodine-Anti-B1 Radioimmunotherapy and BEAM in people with Lymphoma, run by University of Nebraska 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 purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell transplantation. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Lymphoma
What is being tested?
131Iodine-Anti-B1 Radioimmunotherapy and BEAM
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
4 Mar 1996to 10 Dec 2014
Phase
Phase 1
Are there results?
None posted in the registry

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 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pts with a diagnosis of indolent or aggressive B-cell non-Hodgkin's lymphoma who have failed > 3 prior therapies, or are chemo resistant or refractory. Patients must be otherwise eligible for high-dose therapy with the BEAM protocol and ABMT or PSCT.
  • Pts without evidence of severe organ dysfunction.
  • The pre-transplant bone marrow biopsy must show no evidence of marrow involvement if an autologous BMT is to be performed and adequate cellularity, alternatively autologous PSCT will be considered if the bone marrow involvement is <25%.
  • The pt must have no other major medical problems and specifically life expectancy must be at least 4 months post transplant, with a performance status Karnofsky score of >70.
  • Pts with evidence that their tumor tissue expresses the CD20 antigen. Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody or flow cytometry studies are acceptable evidence of CD20 positivity. Testing of tumor tissue from any time in the course of the patient's disease is acceptable.
  • Pts must have normal renal function (creatinine < 2.0 mg/dL) and hepatic function (bilirubin < 2.0 mg/dL) within seven days of study entry.
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  • Pts with DLCO >50% of predicted.
  • If pt is >60 years or has a significant cardiac history (MI or CHF) or has received >350 mg/m2 of Adriamycin and ejection fraction must be >40%.
  • Pts must give written informed consent and sign an approved informed consent form prior to study entry.
  • ts must have bidimensionally measurable disease.
  • Females of child-bearing potential must have a negative serum pregnancy test prior to enrollment to the study, followed by the use of an effective method of birth control.

Who cannot join

  • Pts with more than 25% of the intratrabecular marrow space involved by lymphoma in a unilateral bone marrow biopsy specimens as assessed microscopically prior to study entry.
  • Pts who have received cytotoxic chemotherapy, radiation therapy or immunosuppressants within THREE weeks prior to the radioimmunoconjugate dose or who exhibit persistent clinical evidence of toxicity. The use of steroids must have been discontinued (except maintenance-dose steroids).
  • Pts with obstructive hydronephrosis.
  • Pts with evidence of active infection requiring intravenous antibiotics at the time of study entry.
  • Pts with New York Heart Association class 3 or 4 heart disease or other serious illness that would preclude evaluation.
  • Pts with prior malignancy other than lymphoma, except for adequately treated skin ca, in situ cervical ca, or other ca for which patient has been disease-free for 5 years.
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  • Pts with known HIV infection.
  • Pts with known brain or leptomeningeal metastases.
  • Pts who are pregnant. Patients of child-bearing potential must undergo a pregnancy test. Males and females must agree to use effective contraception during the study and females must continue effective contraception for one year following the radioimmunotherapy dose.
  • Pts with previous allergic reactions to iodine. This does not include IV contrast materials.
  • Pts who previously received radioimmunotherapy.
  • Pts with progressive disease in a field that has been previously irradiated with more than 3500 cGy within the past year.
  • Pts who are on another protocol involving non-FDA approved drugs or biologics.
  • No vulnerable subjects will be entered into this study.
  • Pts with a positive HAMA test at baseline will not be entered. Patients with a positive HAMA test at the end of the week following dosimetric dose administration may not continue on to receive the radioimmunotherapy dose without first contacting the FDA.
  • Pts who have not harvested a minimum CD34+ count of 1.5 X 10 6/kg body weight or CFU-GM count of >2.5 X 10 4/kg may not continue onto receive the study treatment.
  • Pts with prior HSCT following high-dose chemo or chemo/radiotherapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

Other trials in United States

About this study

Official title: BEAM + 131Iodine-Anti-B1 Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Recurrent Non-Hodgkin's Lymphoma

The purpose of this study is to assess the safety of 131I-anti-B1 Radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy and hematopoietic stem cell transplantation. The study will also compare the difference in response rates and time to treatment failure between historical control patients receiving high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant and patients receiving radioimmunotherapy and high-dose BEAM or BEAC chemotherapy with autologous hematopoietic stem cell transplant. Patients will receive escalating doses of radioimmunotherapy with anti-B1 radiolabeled with 131Iodine, high-dose carmustine, etoposide, cytarabine and Melphalan (BEAM) chemotherapy, and autologous hematopoietic stem cell transplant.

Read the detailed description

Thirty patients will be enrolled in this study. There will be two administrations of 131I-anti-B1 given to patients, the "dosimetric dose" and the "radioimmunotherapy dose". The dosimetric dose will consist of an infusion of unlabeled Anti-B1 (450 mg) immediately followed by an infusion of Anti-B1 (35 mg) which has been trace labeled with 5mCi of 131I-anti-B1. The total whole body dosimetry dose is then calculated over an approximated one-week time interval from the radioactive clearance data obtained by the Whole Body anterior and posterior gamma camera scans. Based upon dosimetric data calculations specific for each individual patient, a radioimmunotherapy dose will be given consisting of an infusion of unlabeled Anti-B1 (450 mg)immediately followed by an infusion of 35 mg Anti-B1 including a patient specific dose of 131Iodine-Anti-B1. Calculations will be made such that in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result from the administration of the therapeutic activity of 131I-anti-B1. The amount of the unlabeled Anti-B1 administered is not calculated on a body surface area basis, but is given to provide an excess of Anti-B1 independent of tumor burden, splenic uptake, or other causes.

Conditions
Lymphoma
Being tested
131Iodine-Anti-B1 Radioimmunotherapy, BEAM
Keywords
NHL, Non Hodgkins Lymphoma, 131Iodine-Anti-B1 Radioimmunotherapy, Autologous Hematopoietic Stem Cell Transplant, AHSCT
Medical subject headings
Lymphoma, Lymphoma, Non-Hodgkin

What participants receive

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

  • 131Iodine-Anti-B1 RadioimmunotherapyRadiation

    Dosimetric dose of 450 mg unlabeled Anti-B1 followed by 35 mg Anti-B1 which has been trace labeled with 5mCi of 131I-Anti-B1.

  • BEAMDrug

    Also called Carmustine, Etoposide, Cytarabine, and Melphalan

    Carmustine (B) also known as BCNU Etoposide (E) Cytarabine (A) also known as Ara-C and cytosine arabinoside Melphalan (M) also known as alkeran

Study groups in NCT00574509
Study groupRoleWhat they receive
131I-Anti-B1ExperimentalBEAM + 131Iodine-Anti-B1 radioimmunotherapy and autologous HSCT
Receives: Radiation: 131Iodine-Anti-B1 Radioimmunotherapy; Drug: BEAM

What is being measured

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

  1. Safety of 131I-anti-B1 radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy & HSCT

    Safety of 131I-anti-B1 radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy \& HSCT. Calculations will be made such that in a dose escation study, whole body radiation doses of 30, 45, 60, and 75cGy will result from the administration of the therapeutic activity of 131I-anti-B1.

    Measured: During treatment

Secondary outcomes (1)

  1. Comparing high-dose BEAM or BEAC chemo. with autologous HSCT and radioimmunotherapy and high-dose BEAM or BEAC chemo. with autologous HSCT

    Difference in response rates/time to treatment failure between historical control patients receiving high-dose BEAM or BEAC chemo. with autologous HSCT and pateints receiving radioimmunotherapy and high-dose BEAM or BEAC chemo. with autologous HSCT

    Measured: time of registration to time of treatment discontinuation

Timeline

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

  1. First posted17 Dec 2007 (estimated)
  2. Study start4 Mar 1996
  3. Primary completion1 Nov 2014
  4. Study completion10 Dec 2014

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00574509
Sponsor's protocol ID
0165-96-FB
Status last verified
Oct 2023
First submitted
12 Dec 2007
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 131Iodine-Anti-B1 Radioimmunotherapy and BEAM in people with Lymphoma, run by University of Nebraska 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 17 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 10 Oct 2023. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety of 131I-anti-B1 radioimmunotherapy when combined with high-dose BEAM or BEAC chemotherapy & HSCT (time frame: During treatment). 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 NCT00574509.

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 10 Oct 2023.

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