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Mature T-Cell and NK-Cell Non-Hodgkin LymphomaPhase 1NCT02342782

Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T-cell Non-Hodgkin Lymphoma

A Phase 1 study testing Yttrium Y 90 Basiliximab, Carmustine and Etoposide in people with Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma and Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma, run by City of Hope Medical Center 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

This phase I trial studies the side effects and best dose of yttrium Y 90 basiliximab when given together with standard combination chemotherapy before a stem cell transplant in treating patients with mature T-cell non-Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Yttrium Y 90 Basiliximab, Carmustine and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
8 Jun 2020to 18 Nov 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a pathologically confirmed diagnosis of systemic mature T-cell non-Hodgkin lymphoma (NHL) with City of Hope pathology review as per World Health Organization (WHO) classification of lymphomas 2008, who are deemed eligible for high dose therapy and AHCT including patients in:
  • T-NHL histologies including peripheral T-cell lymphomas (PTCLs), cutaneous T-cell lymphomas (CTCLs) and natural killer (NK)/T cell lymphomas
  • First remission after initial first-line therapy (CR1) in PTCL patients, except for anaplastic lymphoma receptor tyrosine kinase (ALK)+ anaplastic large cell lymphoma (ALCL) and CTCL; patients with minimal residual disease after induction therapy may also be eligible at the discretion of the principal investigator (PI)
  • Relapsed/refractory disease, stable disease, partial remission (PR) or complete remission (CR), who have received at least 2 lines of therapy, and do not have an adequate allogenetic stem cell transplant option
  • Life expectancy >= 6 months
  • Karnofsky status >= 70%
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  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
  • Cardiac ejection fraction of >= 50% by echocardiogram or multi gated acquisition scan (MUGA)
  • Forced expiratory volume in one second (FEV1) > 65% of predicted measured, or diffusing capacity of the lung for carbon monoxide (DLCO) > 50% of predicted measured
  • Bilirubin < 1.5 x normal except in cases where abnormal liver function tests (LFTS) are due to involvement with T-NHL
  • Serum glutamic oxaloacetic transaminase (SGOT) AND serum glutamate pyruvate transaminase (SGPT) < 2 x normal except in cases where abnormal LFTS are due to involvement with T-NHL
  • Serum creatinine of < 1.5 mg/dL, and a measured creatinine clearance of > 60 mL/min
  • Patients will be enrolled at collection of at least 3.0 x 10^6 CD34 cells/kg of autologous hematopoietic progenitor cells (HPC-A) by apheresis; a minimum of 2 collection procedures is required, unless collection on day # 1 > 5.0 x 10^6, CD34 cells/kg; a maximum of 10 collections is allowed; bone marrow harvest to supplement apheresis is not allowed
  • Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to =< grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 4 [v4])
  • Body mass index (BMI) > 35% will be considered on a case-by-case basis by the Radiation Oncology principal investigator (P.I.)
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • Systemic chemotherapy or radiation cannot have been given within 4 weeks prior to the Y-90 dose of radioimmunotherapy (RIT), with the exception of single agent cyclophosphamide priming chemotherapy administered for mobilization

Who cannot join

  • Progressive disease
  • Patients should not have any uncontrolled illness including ongoing or active infection requiring therapy
  • Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy; may have received an experimental agent prior to enrolling in the trial
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to basiliximab
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with indium In 111 (111In-) and 90Y-basiliximab-DOTA
  • Prior high dose chemotherapy for autologous hematopoietic cell transplantation or prior allogeneic transplantation
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  • Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records by the Radiation Oncology PI; patients who have had prior external beam radiation > 2000 cGy (at 180 to 200 cGy per day) to the lung will be ineligible; patients with ANY prior radiation to the heart are ineligible; patients with > 500 cGy to the kidney will be excluded from the study; Note: patients who have had electron beam therapy are still eligible and will be evaluated on a case by case basis by the Radiation Oncology PI
  • Presence of antibody against basiliximab in serum (only required for patients who have received prior antibody)
  • Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible; any history of myelodysplasia is excluded
  • Active hepatitis B or C viral infection or hepatitis B surface antigen positive
  • Patients with a detectable human immunodeficiency virus (HIV) viral load or who are HIV-positive AND have a resistant genotype
  • Patients with psychosocial circumstances or illnesses that preclude protocol participation (to be determined by P.I.)
  • Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia is excluded; this includes, but is not limited to, del(5), del(7), del(11)
  • Evidence of marrow disease by flow and morphology after upfront or salvage cytoreductive therapy and before stem cell mobilization
  • Bone marrow (BM) harvest required to reach adequate cell dose for transplant
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Phase I Study of Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Plus Standard BEAM Conditioning for Autologous Hematopoietic Cell Transplantation in Patients With Mature T-Cell Non-Hodgkin Lymphoma: the aTAC BEAM Regimen

This phase I trial studies the side effects and best dose of yttrium Y 90 basiliximab when given together with standard combination chemotherapy before a stem cell transplant in treating patients with mature T-cell non-Hodgkin lymphoma. Radioactive substances linked to monoclonal antibodies, such as yttrium Y 90 basiliximab, can bind to cancer cells and give off radiation which may help kill cancer cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving yttrium Y 90 basiliximab and chemotherapy before a stem cell transplant may help kill any cancer cells that are in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells that were collected from the patient's blood and stored before treatment are later returned to the patient to replace the blood-forming cells that were destroyed.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine if administration of 90Y-basiliximab/DOTA (yttrium Y 90 basiliximab), when given in combination with standard dose BEAM, as conditioning for autologous hematopoietic cell transplant (AHCT), is safe, by evaluation of toxicities, including type, frequency, severity, attribution, time course and duration.

II. To determine the maximum tolerated dose (MTD) of 90Y-basiliximab/DOTA when given in combination with standard dose BEAM, in patients with T-cell non-Hodgkin lymphoma (T-NHL) as part of conditioning for AHCT.

SECONDARY OBJECTIVES:

  1. To characterize and evaluate hematologic recovery in terms of neutrophil and platelet engraftment time.

II. To estimate radiation doses to the whole body and normal organs through serial imaging studies.

III. To estimate overall survival, progression-free survival, non-relapse mortality and cumulative incidence of relapse/progression at 100-days (non-relapse mortality [NRM] only), 1-year and 2-years.

OUTLINE: This is a dose-escalation study of yttrium Y 90 basiliximab.

Patients receive yttrium Y 90 basiliximab intravenously (IV) on days -21 and -14, carmustine IV over 1-2 hours on days -7 and -6, cytarabine IV twice daily (BID) on days -5 to -2, etoposide IV BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplant on day 0.

After completion of study treatment, patients are followed up at 30, 100, and 180 days and 1, 1.5, and 2 years.

Being tested
Yttrium Y 90 Basiliximab, Carmustine, Etoposide, Cytarabine, Melphalan
Medical subject headings
Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous

What participants receive

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

  • Yttrium Y 90 BasiliximabBiological

    Also called 90Y Basiliximab

    Given IV

  • CarmustineDrug

    Also called FDA 0345, BCNU, BiCNU

    Given IV

  • EtoposideDrug

    Also called Lastet, VP-16

    Given IV

  • CytarabineDrug

    Also called CHX-3311, U-19920, Ara-C, Cytosar

    Given IV

  • MelphalanDrug

    Also called Alkeran, L-PAM

    Given IV

  • Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called Autologous Stem Cell Transplantation

    Undergo AHCT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT02342782
Study groupRoleWhat they receive
Treatment (yttrium Y 90 basiliximab, BEAM, AHCT)ExperimentalPatients receive yttrium Y 90 basiliximab IV on days -21 and -14, carmustine IV over 1-2 hours on days -7 and -6, cytarabine IV BID on days -5 to -2, etoposide IV BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplant on day 0.
Receives: Biological: Yttrium Y 90 Basiliximab; Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine; Drug: Melphalan; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

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

  1. MTD of yttrium Y 90 basiliximab defined as the highest dose in which fewer than 33% of patients experience dose limiting toxicity attributable to study treatment, among those evaluable for toxicity

    Dose limiting toxicities will be graded by the Modified Bearman scale.

    Measured: 30 days post-transplant

  2. Incidence of toxicities assessed using National Cancer Institute (NCI) CTCAE version 4.03

    Observed toxicities will be summarized by type (organ affected or laboratory determination such as absolute neutrophil count), severity (by NCI CTCAE version 4.03 and nadir or maximum values for lab measures), date of onset, duration, reversibility, and attribution.

    Measured: Up to 100 days post-transplant

Secondary outcomes (7)

  1. Disease response by Cheson 2007 criteria

    Measured: Up to 2 years post-transplant

  2. Engraftment: neutrophil and platelet recovery

    Measured: Up to 2 years post-transplant

  3. Overall survival

    Survival estimates will be calculated using the Kaplan-Meier method.

    Measured: From start of therapy (stem cell infusion) to death from any cause, assessed up to 2 years post-transplant

  4. Progression-free survival

    Survival estimates will be calculated using the Kaplan-Meier method.

    Measured: From start of therapy (stem cell infusion) to the first observation of disease relapse/progression or death from any cause, assessed up to 2 years post-transplant

  5. Non-relapse mortality

    The cumulative incidence of relapse/progression and non-relapse mortality will be calculated as competing risks using the Gray method.

    Measured: From start of therapy until non-disease related death, or last follow-up, whichever comes first, assessed up to 2 years post-transplant

  6. Cumulative incidence of relapse/progression

    The cumulative incidence of relapse/progression and non-relapse mortality will be calculated as competing risks using the Gray method.

    Measured: From start of therapy (stem cell infusion) to the first observation of disease relapse/progression, assessed up to 2 years post-transplant

  7. Absorbed radiation dose to organs assessed by nuclear scan images

    Measured: Up to day -14

Timeline

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

  1. First posted21 Jan 2015 (estimated)
  2. Study start8 Jun 2020
  3. Primary completion18 Sep 2020
  4. Study completion18 Nov 2024

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02342782
Sponsor's protocol ID
14349
Other IDs
NCI-2015-00019, 14349
Status last verified
Mar 2025
First submitted
15 Jan 2015
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Zain J, Tsai NC, Palmer J, Simpson J, Adhikarla V, Bading JR, Yazaki P, Smith EP, Dandapani S, Song JY, Karras NA, Herrera AF, Salhotra A, Nademanee AP, Nakamura R, Smith DL, Yamauchi D, Poku EK, Biglang-Awa VE, Colcher D, Shively JE, Wu AM, Forman SJ, Wong J, Thomas S. Yttrium-90 anti-CD25 BEAM conditioning for autologous hematopoietic cell transplantation in Peripheral T-cell lymphoma. Blood Adv. 2024 Sep 24;8(18):4812-4822. doi: 10.1182/bloodadvances.2023012497.

    PubMed 38838232

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Yttrium Y 90 Basiliximab, Carmustine and Etoposide in people with Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma and Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma, run by City of Hope Medical Center 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 17 inclusion and 16 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 20 Mar 2025. 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?

MTD of yttrium Y 90 basiliximab defined as the highest dose in which fewer than 33% of patients experience dose limiting toxicity attributable to study treatment, among those evaluable for toxicity (time frame: 30 days post-transplant). The study lists 2 primary outcomes in all. 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 NCT02342782, which also lists 1 linked publication.

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 20 Mar 2025.

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