Burkitt LymphomaPhase 1NCT02483000
Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies
A Phase 1 study testing Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein, Autologous Hematopoietic Stem Cell Transplantation and Carmustine in people with Burkitt Lymphoma and CD20-Positive Neoplastic Cells Present, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating patients with B-cell malignancies that have not responded to treatment or have come back… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burkitt Lymphoma, CD20-Positive Neoplastic Cells Present, Diffuse Large B-Cell Lymphoma
- What is being tested?
- Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein, Autologous Hematopoietic Stem Cell Transplantation and Carmustine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 2 Sep 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must have a histologically confirmed diagnosis of lymphoma expressing the CD20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) as well as other select high-risk lymphomas (e.g., Burkitt?s, double hit diffuse large B-cell lymphoma [DLBCL], transformed indolent B-cell non-Hodgkin lymphoma [B-NHL], etc.) in accordance with current transplant standard of care for these patients
- Creatinine (Cr) < 2.0
- Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert?s syndrome, who may have a total bilirubin above 1.5 mg/dL
- All patients eligible for therapeutic study must have (>= 2 x 10^6 CD34/kg) autologous hematopoietic stem cells harvested and cryopreserved
- Patients must have an expected survival of > 60 days and must be free of major infection
- Patients of childbearing potential must agree to abstinence or the use of effective contraception
- DONOR SELECTION: Not applicable; this protocol employs autologous transplantation, utilizing the patient?s own hematopoietic stem cells obtained from either the peripheral blood or bone marrow
Who cannot join
- Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled 90Y therapy dose
- Inability to understand or give an informed consent
- Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, both kidneys) within 1 year of the treatment date
- Active central nervous system lymphoma
- Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide [DLCO] < 50% predicted, patient on supplemental oxygen, acquired immune deficiency syndrome [AIDS], etc.)
- Pregnancy or breast feeding
Show all 9Show fewer
- Prior bone marrow or stem cell transplant
- Southwest Oncology Group (SWOG) performance status >= 2.0
- Known sensitivity to kanamycin and other aminoglycosides; patients with known hypersensitivity to kanamycin or any other aminoglycoside antibiotic will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Evaluation of Pretargeted Anti-CD20 Radioimmunotherapy Combined With BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk B-Cell Malignancies
This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating patients with B-cell malignancies that have not responded to treatment or have come back after responding to treatment. CD20 is a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches radioactive material to a drug that is designed to target CD20, which brings radioactive material to the cancer cells to kill the cells. This may kill more tumor cells while causing fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell transplant may be more effective in treating patients with B-cell malignancies.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the maximum tolerated dose (MTD) of 90Y activity that can be delivered via pretargeted radioimmunotherapy (PRIT) using B9E9-fusion protein (B9E9-FP), clearing agent (CA), and radiolabeled tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA)-biotin when followed by carmustine, etoposide, cytarabine, and melphalan (BEAM) chemotherapy and autologous stem cell transplantation.
SECONDARY OBJECTIVES:
- To assess the overall and progression-free survival of the above regimen in such patients.
II. To evaluate the response rates of the above therapy.
III. To evaluate the toxicity and tolerability of the above therapy.
IV. To evaluate the feasibility of delivering sequential high-dose PRIT and chemotherapy.
TERTIARY OBJECTIVES:
- Assess biodistribution and pharmacokinetics of B9E9-FP and radiolabeled DOTA-Biotin.
II. Assess ability of the clearing agent (CA) to remove excess B9E9-FP from the serum.
III. Evaluate the impact, if any, of circulating rituximab on biodistributions.
OUTLINE: This is a phase I, dose-escalation study of yttrium Y 90 DOTA-biotin followed by a phase II study.
B9E9-FP INFUSION: Patients receive B9E9-fusion protein intravenously (IV) over a minimum of 2 hours on day -17.
CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.
RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.
BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours twice daily (BID) and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.
STEM CELL INFUSION: Patients undergo autologous peripheral blood stem cell transplant (PBSCT) on day 0 per standard of care.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then annually thereafter.
- Conditions
- Burkitt Lymphoma, CD20-Positive Neoplastic Cells Present, Diffuse Large B-Cell Lymphoma, Indolent Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma
- Being tested
- Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein, Autologous Hematopoietic Stem Cell Transplantation, Carmustine, Clearing Agent, Cytarabine
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD20 B9E9 scFv-Streptavidin Fusion ProteinBiological
Also called Anti-CD20 B9E9 scFv-SA Fusion Protein, Anti-CD20 B9E9-SA Fusion Protein, B9E9 scFvSA Fusion Protein, Recombinant Anti-CD20 B9E9 scFvSA Fusion Protein
Given IV
Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called Autologous Stem Cell Transplantation
Undergo autologous PBSCT
CarmustineDrug
Also called BCNU, Becenum, Becenun, BiCNU
Given IV
Clearing AgentDrug
Given IV
CytarabineDrug
Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
Given IV
EtoposideDrug
Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar
Given IV
Indium In 111-DOTA-BiotinRadiation
Also called In 111-DOTA-Biotin
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
MelphalanDrug
Also called Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard
Given IV
Peripheral Blood Stem Cell TransplantationProcedure or surgery
Also called PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support
Undergo autologous PBSCT
Correlative studies
Yttrium Y 90-DOTA-BiotinRadiation
Also called 90Y-DOTA-Biotin, yttrium Y 90 DOTA-biotin
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (PRIT) | Experimental | B9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17.
CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.
RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.
BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.
STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care. Receives: Biological: Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Drug: Carmustine; Drug: Clearing Agent; Drug: Cytarabine; Drug: Etoposide; Radiation: Indium In 111-DOTA-Biotin; Other: Laboratory Biomarker Analysis; Drug: Melphalan; Procedure: Peripheral Blood Stem Cell Transplantation; Other: Pharmacological Study; Radiation: Yttrium Y 90-DOTA-Biotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Yttrium Y 90 DOTA-biotin Defined as the Dose That is Associated With a True Dose Limiting Toxicity (DLT) Rate of 25%, Where a DLT is Defined as a Therapy-related Grade III or IV Bearman (Transplant) Toxicity
Following the completed observation of the final patient, a two-parameter logistic model will be fit to the data, thereby generating a dose-toxicity curve based on the observed DLT rate at the various dose levels visited. Based on this fitted model, the MTD is estimated to be the dose that is associated with a DLT rate of 25%.
Measured: Up to 30 days after transplant
Secondary outcomes (5)
Dosimetry of Yttrium Y 90 DOTA-biotin
Assessed using OLINDA dosimetry software. The estimated dose to normal organs and tumor sites will be described based on the tumor to normal organ ratios derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of yttrium Y 90 DOTA-biotin.
Measured: Up to 7 days after infusion
Incidence of Toxicity, Defined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Descriptive statistics on the number and percent toxicities will be calculated.
Measured: Up to 30 days after transplant
Overall Response Rate
Descriptive statistics on the responses will be calculated.
Measured: Up to 4 years
Overall Survival
Overall survival will be estimated.
Measured: Up to 4 years
Progression Free Survival (PFS)
If the true 1-year PFS rate using the proposed approach is 54%, then 24 patients will provide 80% power to detect a statistically significant increased rate of PFS from the fixed rate of 30%, based on a one-sample chi-square test with one-sided significance level of 5%.
Measured: 1 year from autologous stem cell transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start1 Feb 2017
- Primary completion17 Nov 2019
- Study completion2 Sep 2020
Why it stopped: Closed early due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Burkitt LymphomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ajay Gopal, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483000
- Sponsor's protocol ID
- 9189
- Other IDs
- NCI-2015-00299, 9189, P01CA044991, P30CA015704
- Status last verified
- Sep 2020
- First submitted
- 23 Jun 2015
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pretargeted Anti-CD20 Radioimmunotherapy Combined With BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT02483000
- Acronym / sponsor ID
- 9189
- Conditions
- Burkitt Lymphoma, CD20-Positive Neoplastic Cells Present, Diffuse Large B-Cell Lymphoma, Indolent Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed early due to lack of funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 17 Nov 2019 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Posted 23 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating patients with B-cell malignancies that have not responded to treatment or have come back after responding to treatment. CD20 is a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches radioactive material to a drug that is designed to target CD20, which brings radioactive material to the cancer cells to kill the cells. This may kill more tumor cells while causing fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell transplant may be more effective in treating patients with B-cell malignancies.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the maximum tolerated dose (MTD) of 90Y activity that can be delivered via pretargeted radioimmunotherapy (PRIT) using B9E9-fusion protein (B9E9-FP), clearing agent (CA), and radiolabeled tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA)-biotin when followed by carmustine, etoposide, cytarabine, and melphalan (BEAM) chemotherapy and autologous stem cell transplantation.
SECONDARY OBJECTIVES:
- To assess the overall and progression-free survival of the above regimen in such patients.
II. To evaluate the response rates of the above therapy.
III. To evaluate the toxicity and tolerability of the above therapy.
IV. To evaluate the feasibility of delivering sequential high-dose PRIT and chemotherapy.
TERTIARY OBJECTIVES:
- Assess biodistribution and pharmacokinetics of B9E9-FP and radiolabeled DOTA-Biotin.
II. Assess ability of the clearing agent (CA) to remove excess B9E9-FP from the serum.
III. Evaluate the impact, if any, of circulating rituximab on biodistributions.
OUTLINE: This is a phase I, dose-escalation study of yttrium Y 90 DOTA-biotin followed by a phase II study.
B9E9-FP INFUSION: Patients receive B9E9-fusion protein intravenously (IV) over a minimum of 2 hours on day -17.
CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15.
RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14.
BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours twice daily (BID) and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2.
STEM CELL INFUSION: Patients undergo autologous peripheral blood stem cell transplant (PBSCT) on day 0 per standard of care.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (PRIT) | Experimental | Biological: Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein, Procedure: Autologous Hematopoietic Stem Cell Transplantation, Drug: Carmustine, Drug: Clearing Agent, Drug: Cytarabine, Drug: Etoposide, Radiation: Indium In 111-DOTA-Biotin, Other: Laboratory Biomarker Analysis, Drug: Melphalan, Procedure: Peripheral Blood Stem Cell Transplantation, Other: Pharmacological Study, Radiation: Yttrium Y 90-DOTA-BiotinB9E9-FP INFUSION: Patients receive B9E9-fusion protein IV over a minimum of 2 hours on day -17. CLEARING AGENT INFUSION: Patients receive clearing agent IV over a minimum of 30 minutes on day -15. RADIOBIOTIN INFUSION: Patients receive indium In 111-DOTA-biotin IV and yttrium Y 90 DOTA-biotin IV over 2-5 minutes on day -14. BEAM CHEMOTHERAPY: Patients receive BEAM chemotherapy comprising carmustine IV over 3 hours on day -7; etoposide IV over 2 hours BID and cytarabine IV over 4 hours BID on days -6 to -3; and melphalan IV over 30 minutes on day -2. STEM CELL INFUSION: Patients undergo autologous PBSCT on day 0 per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have a histologically confirmed diagnosis of lymphoma expressing the CD20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) as well as other select high-risk lymphomas (e.g., Burkitt?s, double hit diffuse large B-cell lymphoma [DLBCL], transformed indolent B-cell non-Hodgkin lymphoma [B-NHL], etc.) in accordance with current transplant standard of care for these patients
- Creatinine (Cr) < 2.0
- Bilirubin < 1.5 mg/dL, with the exception of patients thought to have Gilbert?s syndrome, who may have a total bilirubin above 1.5 mg/dL
- All patients eligible for therapeutic study must have (>= 2 x 10^6 CD34/kg) autologous hematopoietic stem cells harvested and cryopreserved
- Patients must have an expected survival of > 60 days and must be free of major infection
Key exclusion criteria (9 listed)
- Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled 90Y therapy dose
- Inability to understand or give an informed consent
- Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, both kidneys) within 1 year of the treatment date
- Active central nervous system lymphoma
- Other serious medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of the lung for carbon monoxide [DLCO] < 50% predicted, patient on supplemental oxygen, acquired immune deficiency syndrome [AIDS], etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-CD20 B9E9 scFv-Streptavidin Fusion ProteinAlso: Anti-CD20 B9E9 scFv-SA Fusion Protein, Anti-CD20 B9E9-SA Fusion Protein, B9E9 scFvSA Fusion Protein, Recombinant Anti-CD20 B9E9 scFvSA Fusion ProteinGiven IV | Biological | Treatment (PRIT) |
| Autologous Hematopoietic Stem Cell TransplantationAlso: Autologous Stem Cell TransplantationUndergo autologous PBSCT | Procedure or surgery | Treatment (PRIT) |
| CarmustineAlso: BCNU, Becenum, Becenun, BiCNUGiven IV | Drug | Treatment (PRIT) |
| Clearing AgentGiven IV | Drug | Treatment (PRIT) |
| CytarabineAlso: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinoneGiven IV | Drug | Treatment (PRIT) |
| EtoposideAlso: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, ToposarGiven IV | Drug | Treatment (PRIT) |
| Indium In 111-DOTA-BiotinAlso: In 111-DOTA-BiotinGiven IV | Radiation | Treatment (PRIT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (PRIT) |
| MelphalanAlso: Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine MustardGiven IV | Drug | Treatment (PRIT) |
| Peripheral Blood Stem Cell TransplantationAlso: PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell SupportUndergo autologous PBSCT | Procedure or surgery | Treatment (PRIT) |
| Pharmacological StudyCorrelative studies | Other | Treatment (PRIT) |
| Yttrium Y 90-DOTA-BiotinAlso: 90Y-DOTA-Biotin, yttrium Y 90 DOTA-biotinGiven IV | Radiation | Treatment (PRIT) |
Primary outcome
Maximum Tolerated Dose (MTD) of Yttrium Y 90 DOTA-biotin Defined as the Dose That is Associated With a True Dose Limiting Toxicity (DLT) Rate of 25%, Where a DLT is Defined as a Therapy-related Grade III or IV Bearman (Transplant) Toxicity
Time frame: Up to 30 days after transplant
Following the completed observation of the final patient, a two-parameter logistic model will be fit to the data, thereby generating a dose-toxicity curve based on the observed DLT rate at the various dose levels visited. Based on this fitted model, the MTD is estimated to be the dose that is associated with a DLT rate of 25%.
5 secondary outcomes
Dosimetry of Yttrium Y 90 DOTA-biotin
Time frame: Up to 7 days after infusion
Incidence of Toxicity, Defined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Time frame: Up to 30 days after transplant
Overall Response Rate
Time frame: Up to 4 years
Overall Survival
Time frame: Up to 4 years
Progression Free Survival (PFS)
Time frame: 1 year from autologous stem cell transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Gopal principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein, Autologous Hematopoietic Stem Cell Transplantation and Carmustine in people with Burkitt Lymphoma and CD20-Positive Neoplastic Cells Present, run by Fred Hutchinson Cancer 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 23 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 23 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (MTD) of Yttrium Y 90 DOTA-biotin Defined as the Dose That is Associated With a True Dose Limiting Toxicity (DLT) Rate of 25%, Where a DLT is Defined as a Therapy-related Grade III or IV Bearman (Transplant) Toxicity (time frame: Up to 30 days after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2020.