ClinicalTrials.gg
CompletedNCT00574509Updated Oct 10, 2023

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

A Phase 1 interventional study of 131Iodine-Anti-B1 Radioimmunotherapy and BEAM in Lymphoma, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by University of Nebraska · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2014, 11 years 11 months ago, and no results have been posted to the registry.
  • Registered 11 years 9 months after the study started (first participant enrolled Mar 1996, registered Dec 2007).
Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
19 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Lymphoma

Keywords

  • NHL
  • Non Hodgkins Lymphoma
  • 131Iodine-Anti-B1 Radioimmunotherapy
  • Autologous Hematopoietic Stem Cell Transplant
  • AHSCT
03

In context

Lymphoma

5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.

This study's enrollment of 34 is below the median of 40 across 4,534 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    131I-Anti-B1

    BEAM + 131Iodine-Anti-B1 radioimmunotherapy and autologous HSCT

    Radiation: 131Iodine-Anti-B1 Radioimmunotherapy · Drug: BEAM

Interventions

  • Radiation131Iodine-Anti-B1 Radioimmunotherapy

    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.

  • DrugBEAM

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

    Also known as: Carmustine, Etoposide, Cytarabine, and Melphalan

06

What researchers measure

Primary outcomes

  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.

    Time frame: During treatment

Secondary outcomes

  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

    Time frame: time of registration to time of treatment discontinuation

07

Study locations

1 site
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198-7680, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 1996 to primary completion in Nov 2014, 223 months.

Of 276 non-industry phase 1 interventional studies under Lymphoma, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 76. This study's 223 months is above that.

Counting every sponsor, half of 537 studies reached it within 47 months; a quarter within 30 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2007
First posted
Dec 17, 2007
StartActual
Mar 4, 1996
Primary completionActual
Nov 1, 2014
CompletionActual
Dec 10, 2014
Last update
Oct 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00574509
Responsible party
Sponsor
First posted
Dec 17, 2007
Start date
Mar 4, 1996
Primary completion
Nov 1, 2014
Completion
Dec 10, 2014
Last update
Oct 10, 2023

Study contacts

Julie M Vose, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: BEAM regimen

Start the discussion