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Refractory Non Hodgkin LymphomaPhase 2NCT01811368

Zevalin Before Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

A Phase 2 study testing rituximab, ibritumomab tiuxetan and anti-thymocyte globulin in people with Refractory Non Hodgkin Lymphoma and Relapsed Non Hodgkin Lymphoma, run by Joseph Tuscano at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase II trial studies how well ibritumomab tiuxetan before donor peripheral blood stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
rituximab, ibritumomab tiuxetan and anti-thymocyte globulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
12 Mar 2013to Dec 2023
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed relapsed cluster of differentiation (CD)20+ non-Hodgkin's lymphoma (NHL) (included in this category are follicular grade I, II, III, marginal zone, mantle cell, diffuse large B cell, small lymphocytic lymphoma) and CD20+ Hodgkin's disease for which standard curative therapy does not exist or is no longer effective
  • Patients must have had at least one prior chemotherapeutic regimen; steroids alone and local radiation do not count as regimens; radiotherapy must have been completed at least 4 weeks prior to entry into the study; Rituxan alone does not count as a regimen; however, Bexxar or Zevalin (ibritumomab tiuxetan) do and patients must have completed radioimmunotherapy (RIT) > 12 months prior to enrollment
  • Karnofsky performance status of ≥ 60%
  • Life expectancy of greater than 3 months
  • Total bilirubin within institutional normal limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times institutional upper limit of normal
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  • Creatinine within normal institutional limits OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Blood counts no restrictions
  • Patients who had anything less than a CR (PR, SD or progressive disease) to their last salvage regimen
  • Ability to understand and the willingness to sign a written informed consent document
  • Patients fit for non-myeloablative transplantation or best treatment that have an available matched (9/10 or better) related or unrelated donor
  • Patients who are considered rituximab refractory (defined as progression within 6 months of their last rituximab-containing regimen)

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, rituximab within three months (unless there is evidence of progression), or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded; this does not include the use of steroids which may continue until two days prior to enrollment
  • Patients may not be receiving any other investigational agents
  • Failure to obtain insurance/payment authorization for Zevalin, unless the subject agrees to cover the cost
  • Patients with known active brain metastases, other neurological disorders/dysfunction or a history of seizure disorder, or other neurological dysfunction should be excluded from this clinical trial because of their poor prognosis
  • Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
  • Patients with symptomatic coronary artery disease, uncontrolled congestive heart failure; left ventricular ejection fraction is not required to be measured, however if it is measured, patient is excluded if ejection fraction is < 30%
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  • Patients requiring supplementary continuous oxygen; diffusion capacity of the lung of carbon monoxide (DLCO) is not required to be measured, however if it is measured, patient is excluded if DLCO < 35%
  • Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function and histology, and for the degree of portal hypertension
  • Patients with any of the following liver function abnormalities will be excluded:
  • Fulminant liver failure
  • Cirrhosis with evidence of portal hypertension or bridging fibrosis
  • Alcoholic hepatitis
  • Esophageal varices
  • A history of bleeding esophageal varices
  • Hepatic encephalopathy
  • Uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time
  • Ascites related to portal hypertension
  • Chronic viral hepatitis with total serum bilirubin > 3 mg/dL
  • Symptomatic biliary disease
  • Pregnant women are excluded from this study
  • Human immunodeficiency virus (HIV)-positive patients

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Davis

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: Use of Zevalin to Enhance the Efficacy of Non-Myeloablative Allogeneic Transplantation in Patients With Relapsed or Refractory CD20+ Non-Hodgkin's Lymphoma

This phase II trial studies how well ibritumomab tiuxetan before donor peripheral blood stem cell transplant works in treating patients with relapsed or refractory non-Hodgkin lymphoma. Giving rituximab, antithymocyte globulin, and total-lymphoid irradiation (TLI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving rituximab, antithymocyte globulin, and TLI before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody before a donor peripheral blood stem cell transplant may be an effective treatment for non-Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To measure the response conversion (progressive disease [PD]/stable disease [SD] to partial response [PR] and complete response [CR]).

SECONDARY OBJECTIVES:

  1. To assess the time to engraftment/chimerism. II. To assess the rate of acute and chronic graft-versus-host disease (GVHD). III. To assess toxicity. IV. To determine the overall survival. V. To investigate immune functional and phenotypic analysis. VI. To measure two year event free survival (EFS).

OUTLINE:

CONDITIONING REGIMEN: Patients receive rituximab intravenously (IV) on days -21 and 14, ibritumomab tiuxetan IV on day -14, TLI on days -11 to -7 and -4 to -1, and antithymocyte globulin IV over 4-6 hours on days -11 to -7. Patients also undergo TLI on days -11 to -7 and -4 to -1.

TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0.

GVHD PROPHYLAXIS: Patients receive cyclosporine orally (PO) twice daily (BID) or IV on days -3 to 56 with taper to 6 months and mycophenolate mofetil PO BID or IV on days 0-28.

After completion of study treatment, patients are followed up periodically.

Being tested
rituximab, ibritumomab tiuxetan, anti-thymocyte globulin, total nodal irradiation, peripheral blood stem cell transplantation
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.

  • rituximabBiological

    Also called IDEC-C2B8, Mabthera, Rituxan

    Given IV

  • ibritumomab tiuxetanBiological

    Also called Zevalin

    Given IV

  • anti-thymocyte globulinBiological

    Also called ATG, ATGAM, lymphocyte immune globulin, Thymoglobulin

    Given IV

  • total nodal irradiationRadiation

    Also called TLI, total lymphoid irradiation

    Undergo TLI

  • peripheral blood stem cell transplantationProcedure or surgery

    Also called PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell

    Undergo allogeneic peripheral blood stem cell transplant

  • allogeneic hematopoietic stem cell transplantationProcedure or surgery

    Undergo allogeneic peripheral blood stem cell transplant

  • cyclosporineDrug

    Also called cyclosporin, cyclosporin A, CYSP, Sandimmune

    Given PO or IV

  • mycophenolate mofetilDrug

    Also called Cellcept, MMF

    Given PO or IV

Study groups in NCT01811368
Study groupRoleWhat they receive
Treatment (ibritumomab tiuxetan, allogeneic PBSCT)ExperimentalCONDITIONING REGIMEN: Patients receive rituximab IV on days -21 and 14, ibritumomab tiuxetan IV on day -14, TLI on days -11 to -7 and -4 to -1, and antithymocyte globulin IV over 4-6 hours on days -11 to -7. Patients also undergo TLI on days -11 to -7 and -4 to -1. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO BID or IV on days -3 to 56 with taper to 6 months and mycophenolate mofetil PO BID or IV on days 0-28.
Receives: Biological: rituximab; Biological: ibritumomab tiuxetan; Biological: anti-thymocyte globulin; Radiation: total nodal irradiation; Procedure: peripheral blood stem cell transplantation; Procedure: allogeneic hematopoietic stem cell transplantation; Drug: cyclosporine; Drug: mycophenolate mofetil

What is being measured

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

  1. Response conversion rate (PD/SD to PR and CR)

    Calculated along with 95% confidence intervals (CI). Logistic regression will be used to assess the impact of patient characteristics (e.g., low/high lactate dehydrogenase isoenzyme-3 [LDH] or immunologic correlates) on the response conversion rate.

    Measured: Up to 60 days post-transplant

Secondary outcomes (6)

  1. Time to engraftment/chimerism

    Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups of patients will be made using the logrank test. Cox (proportional hazards) regression will be used to evaluate multivariable predictive models of time-to-event outcomes when proper.

    Measured: Up to 3 years

  2. Rate of acute GVHD

    Measured: Up to day 730

  3. Rate of chronic GVHD

    Measured: Up to day 730

  4. Overall survival

    Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups of patients will be made using the logrank test. Cox (proportional hazards) regression will be used to evaluate multivariable predictive models of time-to-event outcomes when proper.

    Measured: Up to day 730

  5. EFS

    Comparison of time-to-event endpoints by important subgroups of patients will be made using the logrank test. Cox (proportional hazards) regression will be used to evaluate multivariable predictive models of time-to-event outcomes when proper.

    Measured: 2 years

  6. Toxicities

    Toxicities as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0

    Measured: Up to day 730

Timeline

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

  1. First posted14 Mar 2013 (estimated)
  2. Study start12 Mar 2013
  3. Primary completionApr 2023 (estimated)
  4. Study completionDec 2023 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01811368
Sponsor's protocol ID
367905
Other IDs
UCDCC#233, NCI-2012-02753
Status last verified
Nov 2022
First submitted
11 Mar 2013
Last updated
30 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab, ibritumomab tiuxetan and anti-thymocyte globulin in people with Refractory Non Hodgkin Lymphoma and Relapsed Non Hodgkin Lymphoma, run by Joseph Tuscano 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 12 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 30 Nov 2022. 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 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?

Results are not available in the source record.

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?

Response conversion rate (PD/SD to PR and CR) (time frame: Up to 60 days 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 NCT01811368.

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 30 Nov 2022.

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