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Lymphoma, Non-HodgkinPhase 1NCT00186589

90Y-IBRITUMOMAB Tiuxetan and AHCI With HD Chemotherapy and Autologous Transplantation for Relapsed or Resistant NHL

A Phase 1 study testing 90Y Ibritumomab tiuxetan in people with Lymphoma, Non-Hodgkin and Blood and Marrow Transplant (BMT), run by Stanford University 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

To test a new way to approach hematopoietic stem cell transplantation for Relapsed or Resistant Non-Hodgkin's Lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
90Y Ibritumomab tiuxetan
How many people
30 participants
Where
1 siteUnited States
Study dates
May 2004to Jul 2007
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 4.1 Histologically proven, recurrent or refractory, CD20+ B-cell NHL reviewed at SUMC.
  • 4.11 The definition of recurrent disease is: previous partial response (PR) or complete response (CR) to treatment followed by disease progression.
  • 4.12 The definition of refractory disease is: failure to achieve a PR or CR with or progression during primary induction therapy or subsequent salvage therapy. Patients who respond to treatment but progress within 60 days will also be considered refractory.
  • 4.13 CD20 expression may be determined by immunohistochemistry or flow cytometry. Whenever possible, confirmation of CD20+ status should be made on current, active disease.
  • 4.14 The definition of NHL will be made by SUMC pathologists using the World Health Organization Classification of Hematopoietic and Lymphoid Tissues (Appendix A).
  • 4.15 The diagnosis should be made by excisional biopsy whenever possible. Biopsy of refractory or recurrent disease is preferred but fine needle aspirate with supportive morphology and immunohistochemistry is acceptable. Paraffin tissue for tissue array studies will be sought for every patient.
Show all 41Show fewer
  • 4.2 Age 18-70 years
  • 4.21 Age will be based on actual date of birth.
  • 4.22 Pediatric patients are not eligible for this study because they are transplanted in a separate dedicated unit with their own protocols.
  • 4.3 ECOG performance status 0-2 (Appendix B)
  • 4.4 Computerized tomography scans of the chest, abdomen and pelvis within 4 weeks of registration. Assessment of response to last chemotherapy prior to registration is mandatory.
  • 4.41 Response will be assessed according to the international consensus criteria (Cheson et al. J Clin Oncol 17:1244, 1999)
  • 4.42 Standard definitions of the chest, abdomen and pelvis will be used for radiographic studies.
  • 4.5 Gallium scan or PET scan determination of disease within 4 weeks of registration is highly recommended.
  • 4.51 Gallium or PET scans will be whole body scans
  • 4.6 Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration. Patients must have no or <25% involvement of the intratrabecular bone marrow cellularity by NHL.
  • 4.7 Adequate (> 4 x 10^6/kg CD34+) peripheral blood progenitor cells collected by apheresis.
  • 4.8 Women of child-bearing potential and sexually active males are strongly advised to use an accepted and effective method of birth control.
  • 4.9 No chemotherapy other than corticosteroids should be administered within 4 weeks of the initiation of protocol therapy.
  • 4.10 Pretreatment absolute neutrophil count > 1000/mm^3 and platelet count > 150,000/ mm^3.
  • 4.11 Patients must have a pretreatment serum bilirubin < 2 x the institutional ULN, transaminases < 2 x the institutional ULN, a serum creatinine < 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula (all tests must be performed within 28 days prior to registration):
  • Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female X creatinine (mg/dl)
  • 4.12 Patients must have an EKG within 42 days prior to registration that shows no significant abnormalities that are suggestive of active cardiac disease.
  • 4.13 Patients must have a radionuclide ejection fraction >45% within 42 days of registration.
  • 4.14 Patients must have a corrected diffusion capacity 70% or greater.
  • 4.15 Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • 4.30 Absolute neutrophil count recovery to > 1000/mm^3 and platelet recovery count to > 100,000/ mm^3.
  • 4.31 Corrected diffusing capacity > 60%.
  • 4.32 Resting ejection fraction of > 45%.
  • 4.33 Serum bilirubin < 2, SGOT (AST) < 2 x ULN, SGPT (ALT) < 2 x ULN. Creatinine < 2 x the ULN and measured or estimated creatinine clearance > 60 cc/min. Exclusion Criteria:Exclusion Criteria - Step 1
  • 4.16 Patients with known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide are not eligible.
  • 4.17 No prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.
  • 4.18 Patients known to be human immunodeficiency virus (HIV)-positive are ineligible because the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population. The antibody test for HIV must be performed within 42 days of registration.
  • 4.19 Patients requiring therapy for coronary artery disease, cardiomyopathy, dysrhythmia, or congestive heart failure are not eligible.
  • 4.20 Pregnant or breast-feeding women are ineligible due to the known birth defects associated with the treatments used in this study.
  • 4.21 Patients with prior radiotherapy to >25% of the active marrow are excluded.
  • 4.22 Patients treated previously with radioimmunotherapy are excluded.
  • 4.23 Patients with pleural effusion or ascites are excluded.
  • 4.24 Patients may have received prior rituximab but not within the past 4 weeks.
  • 4.25 Patients with prior autologous transplantation are ineligible.
  • 4.26 Patients with CNS disease are ineligible.

Who cannot join

  • 4.33 Drop in diffusing capacity of >25% from study entry.
  • 4.34 Drop in resting ejection fraction > 20%.
  • 4.35 Failure to recover peripheral blood counts (ANC > 1000/mm^3 and platelet recovery count to > 100,000/mm^3 within 4 weeks after radioimmunotherapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: 90Y-Ibritumomab Tiuxetan and Autologous Hematopoietic Cell Infusion Followed by High Dose Chemotherapy and Autologous Transplantation for Relapsed or Resistant Non-Hodgkin's Lymphoma

To test a new way to approach hematopoietic stem cell transplantation for Relapsed or Resistant Non-Hodgkin's Lymphoma.

Read the detailed description

This is a single center phase I dose escalation trial of a single course of IDEC-Y2B8 (90Y-ibritumomab tiuxetan, Zevalin) with autologous peripheral blood progenitor cell infusion followed by high dose chemotherapy and AHCT for patients with relapsed or refractory B-cell NHL. In step one, an imaging dose of IDEC-In2B8 (111In- ibritumomab tiuxetan, Zevalin) will be followed one week later by IDEC-Y2B; both will be preceded by an infusion of 250 mg/m2 rituximab. Imaging will be done immediately (within 1 hr), at 4 - 6 hours and at 1, 3, and 6 days after 90Y-ibritumomab tiuxetan.

Being tested
90Y Ibritumomab tiuxetan
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • 90Y Ibritumomab tiuxetanDrug

What is being measured

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

  1. Complete Response

    Measured: completed

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startMay 2004
  3. Primary completionJul 2007
  4. Study completionJul 2007

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00186589
Sponsor's protocol ID
BMT134
Other IDs
80109, BMT134, NCT00186589
Status last verified
Oct 2010
First submitted
14 Sep 2005
Last updated
6 Jun 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 90Y Ibritumomab tiuxetan in people with Lymphoma, Non-Hodgkin and Blood and Marrow Transplant (BMT), run by Stanford University 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 41 inclusion and 3 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 6 Jun 2012. 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?

Complete Response (time frame: completed). 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 NCT00186589.

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 6 Jun 2012.

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