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Recurrent Adult Hodgkin LymphomaPhase 1NCT01476839

Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma

A Phase 1 study testing basiliximab, carmustine and etoposide in people with Recurrent Adult 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 clinical trial studies the side effects and best dose of radiolabeled monoclonal antibody therapy when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with primary refractory (did not respond to treatment) or relapsed (returned… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Recurrent Adult Hodgkin Lymphoma
What is being tested?
basiliximab, carmustine and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
13 Feb 2013to 31 May 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathology confirmation of HL with City of Hope (COH) pathology review
  • Hodgkin lymphoma that is:
  • PIF (primary induction failure): did not enter complete remission with first line of therapy; Note: a patient with PIF who responds to salvage therapy with a PR or CR is also eligible (and would be considered PIF-sensitive)
  • Early 1st relapse: initial CR of > 3 months and < 12 months after 1st line chemotherapy
  • 1st relapsed HL in a patient who is not in CR after 2 cycles of salvage therapy
  • In 2nd or subsequent relapse (RL) whether in CR or not after salvage therapy
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  • Relapse/persistent disease evidenced by a computed tomography and fluorodeoxyglucose (FDG)-positron emission tomography (PET), or bone marrow biopsy
  • 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 diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted measured
  • Bilirubin =< 1.5 x normal
  • Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =< 2 x normal except in cases where abnormal liver function tests (LFTS) are due to involvement with HL
  • Serum creatinine of =< 1.5 mg/dL, and a measured creatinine clearance of >= 60 mL/min
  • Karnofsky status >= 70%
  • Life expectancy >= 6 months
  • Females must not be pregnant or breast feeding, and must use accepted birth control methods; males must use accepted birth control methods
  • Capability of providing informed consent
  • Patients will be enrolled after receiving at least two cycles of salvage cytoreductive chemotherapy and 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
  • Co-enrollment on Institutional Review Board (IRB) #98117, entitled Molecular Pathogenesis of Therapy-Related Leukemia
  • All pre-study and follow-up imaging studies preferably performed at City of Hope
  • Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to =< grade 2 (Common Terminology Criteria for Adverse Events version 4 [CTCAE v4])
  • Body mass index (BMI) > 30% will be considered on a case-by-case basis by the radiation oncology principal investigator (PI)
  • While on this study, patients may not be treated with any other investigational agent for any purpose until relapse or progression

Who cannot join

  • Lymphocyte-predominant Hodgkin lymphoma
  • Prior high dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation
  • 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 any portion of the lung will be ineligible; patients with ANY prior radiation to the heart are ineligible; patients with > 500 cGy to any portion of the kidney will be excluded from the study
  • Presence of antibody against basiliximab (only required for patients who have received prior antibody)
  • Myelodysplasia or any active malignancy other than HL, or < 5 years remission from any other prior malignancy, except adequately treated basal cell or squamous cell carcinoma
  • Active hepatitis B or C viral infection or hepatitis B surface antigen positive
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  • Positive human immunodeficiency virus antibody
  • Patients with psychosocial circumstances or illnesses that preclude protocol participation (to be determined by PI)
  • Co-morbid illnesses that preclude protocol participation (to be determined by PI)
  • 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)
  • Persistent marrow involvement (> 10%) with HL after salvage cytoreductive therapy and before stem cell mobilization
  • Systemic chemotherapy or radiation within 4 weeks prior to the Y-90 dose of radioimmunotherapy (RIT), with the exception of single agent Cytoxan priming chemotherapy administered for mobilization
  • Bone marrow (BM) harvest required to reach adequate cell dose for transplant

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 (a-Tac) Monoclonal Antibody Plus BEAM for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients With Primary Refractory or Relapsed Hodgkin Lymphoma, the "a-Tac BEAM Regimen"

This phase I clinical trial studies the side effects and best dose of radiolabeled monoclonal antibody therapy when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with primary refractory (did not respond to treatment) or relapsed (returned after treatment) Hodgkin lymphoma. Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, 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 stopping them from spreading. Giving radiolabeled monoclonal antibody therapy together with combination chemotherapy may kill more cancer cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety and feasibility of the autologous hematopoietic cell transplantation (AHCT) regimen of yttrium Y-90 basiliximab/DOTA, given in combination with standard dose(s) of BEAM in patients with primary progressive or relapsed Hodgkin lymphoma (HL).

II. To determine the recommended phase II dose (RP2D) and characterize toxicities at each dose level - including time course.

III. To evaluate hematological recovery in terms of neutrophil and platelet engraftment time.

IV. To estimate overall response rate (ORR: complete remission [CR] + partial remission [PR]), response duration, overall survival, progression-free survival, and the cumulative incidence of non-relapse mortality and relapse/progression.

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

VI. To define biodistribution/extended pharmacokinetics of 111indium (In)-basiliximab/DOTA and 90Y- basiliximab/DOTA including terminal elimination, serum half-life (t1/2), and area under the curve (AUC).

OUTLINE: DOSIMETRY STUDY: Patients receive basiliximab intravenously (IV) and indium In 111 basiliximab IV on day -21. Patients undergo indium In 111 imaging scans daily. Patients with appropriate biodistribution continue on to treatment.

TREATMENT: Patients receive basiliximab IV and yttrium Y 90 basiliximab IV on day -14. Patients also receive BEAM chemotherapy comprising carmustine IV over 2 hours on days -7 and -6, etoposide IV over 4 hours twice daily (BID) and cytarabine IV over 2 hours BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic progenitor cell infusion on day 0.

After completion of study treatment, patients are followed up at day 90-100, 180, 1 year, 1.5 years, and 2-5 years.

Being tested
basiliximab, carmustine, etoposide, cytarabine, melphalan
Medical subject headings
Hodgkin Disease

What participants receive

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

  • basiliximabBiological

    Also called SDZ-CHI-621, Simulect

    Given IV

  • carmustineDrug

    Also called BCNU, BiCNU, bis-chloronitrosourea

    Given IV

  • etoposideDrug

    Also called EPEG, VP-16, VP-16-213

    Given IV

  • cytarabineDrug

    Also called ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U

    Given IV

  • melphalanDrug

    Also called Alkeran, CB-3025, L-PAM, L-phenylalanine mustard

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

  • autologous hematopoietic stem cell transplantationProcedure or surgery

    Undergo autologous hematopoietic progenitor cell infusion

  • yttrium Y 90-labeled basiliximabBiological

    Also called 90Y basiliximab

    Given IV

Study groups in NCT01476839
Study groupRoleWhat they receive
Treatment (radiolabeled monoclonal antibody, chemotherapy)ExperimentalDOSIMETRY STUDY: Patients receive basiliximab IV and indium In 111 basiliximab IV on day -21. Patients undergo indium In 111 imaging scans daily. Patients with appropriate biodistribution continue on to treatment. TREATMENT: Patients receive basiliximab IV and yttrium Y 90 basiliximab IV on day -14. Patients also receive BEAM chemotherapy comprising carmustine IV over 2 hours on days -7 and -6, etoposide IV BID over 4 hours and cytarabine IV over 2 hours BID on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic progenitor cell infusion on day 0.
Receives: Biological: basiliximab; Drug: carmustine; Drug: etoposide; Drug: cytarabine; Drug: melphalan; Other: pharmacological study; Other: laboratory biomarker analysis; Procedure: autologous hematopoietic stem cell transplantation; Biological: yttrium Y 90-labeled basiliximab

What is being measured

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

  1. RP2D of Yttrium-90 labeled basiliximab

    RP2D will generally be the highest maximum tolerated dose (MTD), but it may be less than the MTD based on a review of available data/cumulative toxicities. Additional pulmonary toxicity monitoring will be performed among enrolled/treated patients with prior brentuximab vedotin exposure for both portions of the study.

    Measured: Up to 18 months

  2. DLT

    Toxicities will be recorded using two distinct grading systems: the modified Bearman Scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.0 scale. Observed toxicities will be summarized by type, severity, date of onset, duration (for neutropenia only), and attribution.

    Measured: For 30 days post-transplant

Secondary outcomes (8)

  1. Best ORR

    Response will be evaluated using the revised Cheson criteria. Objective tumor response for all patients will be summarized for each dose level, and the number and percent responding combined across dose levels.

    Measured: Up to 5 years

  2. Biodistribution of basiliximab

    Serum basiliximab levels will be evaluated. T1/2 and alpha- and beta- phase will be estimated for each patient using compartmental and non-compartmental methods, with summary statistics tabulated. Exploratory models to predict tumor response, survival, and toxicities from serum data and patient characteristics will be performed to better understand the effect of treatment on patients.

    Measured: Pre-basiliximab infusion; pre radiolabeled basiliximab infusion; 2 and 4-6 hours post radiolabeled basiliximab infusion; and then 1, 2, 3-4, 5, and 6 days post radiolabeled basiliximab infusion

  3. Cumulative incidence of non-relapsed mortality (NRM)

    Cumulative relapse incidence will be estimated treating non-relapse related death events as competing risks and conversely, NRM will be calculated controlling for relapse as a competing risk. Cumulative incidence of NRM and relapse-related mortality will be calculated using the method of Gooley et al. Cumulative incidence differences will be assessed by Gray's test.

    Measured: From stem cell infusion to death from any cause other than disease relapse or progression, assessed up to 5 years

  4. Cumulative incidence of relapse/progression incidence

    Cumulative relapse incidence will be estimated treating non-relapse related death events as competing risks and conversely, NRM will be calculated controlling for relapse as a competing risk. Cumulative incidence of NRM and relapse-related mortality will be calculated using the method of Gooley et al. Cumulative incidence differences will be assessed by Gray's test.

    Measured: Up to 5 years

  5. Incidence of toxicity

    Observed toxicities will be summarized by type (organ affected or laboratory determination such as absolute neutrophil count), severity (by NCI CTCAE v4.0 and nadir or maximum values for lab measures), dates of onset, duration, reversibility, and attribution.

    Measured: Up to 100 days post-infusion

  6. Overall survival (OS)

    OS will be estimated using the KM product-limit method; 95% CIs will be calculated using the logit transformation and the Greenwood variance estimate. OS will be estimated using two different start times (from radio-labeled therapeutic infusion and from stem cell infusion) to death from any cause.

    Measured: Time from transplant to death from any cause, assessed up to 5 years

  7. Progression free survival (PFS)

    PFS will be estimated using the Kaplan-Meier (KM) product-limit method. 95% confidence intervals (CIs) will be calculated using the logit transformation and the Greenwood variance estimate. PFS will be estimated using two different start times (from radio-labeled therapeutic infusion and from stem cell infusion) to recurrence, progression, or death from any cause.

    Measured: Time from transplant to the first observation of disease progression or death from any cause, whichever occurs first, assessed at 5 years

  8. Response duration

    Measured: Time from when criteria for response (CR or PR) are met to the first documentation of relapse or progression, assessed up to 5 years

Timeline

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

  1. First posted22 Nov 2011 (estimated)
  2. Study start13 Feb 2013
  3. Primary completion24 Jul 2021
  4. Study completion31 May 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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01476839
Sponsor's protocol ID
08179
Other IDs
NCI-2011-03334, P01CA030206, R21CA185875-01
Status last verified
Oct 2026
First submitted
18 Nov 2011
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Herrera AF, Palmer J, Adhikarla V, Yamauchi D, Poku EK, Bading J, Yazaki P, Dandapani S, Mei M, Chen R, Cao T, Karras N, McTague P, Nademanee A, Popplewell L, Sahebi F, Shively JE, Simpson J, Smith DL, Song J, Spielberger R, Tsai NC, Thomas SH, Forman SJ, Colcher D, Wu AM, Wong J, Smith E. Anti-CD25 radioimmunotherapy with BEAM autologous hematopoietic cell transplantation conditioning in Hodgkin lymphoma. Blood Adv. 2021 Dec 14;5(23):5300-5311. doi: 10.1182/bloodadvances.2021004981.

    PubMed 34638132

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing basiliximab, carmustine and etoposide in people with Recurrent Adult 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 22 inclusion and 13 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 15 Oct 2026. 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?

RP2D of Yttrium-90 labeled basiliximab (time frame: Up to 18 months). 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 NCT01476839, 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 15 Oct 2026.

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