Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00019 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 14349 | Other Identifier | City of Hope Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (yttrium Y 90 basiliximab, BEAM, AHCT) | Experimental | Patients 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yttrium Y 90 Basiliximab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days post-transplant |
| 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. | Up to 100 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Disease response by Cheson 2007 criteria | Up to 2 years post-transplant | |
| Engraftment: neutrophil and platelet recovery | Up to 2 years post-transplant | |
| Overall survival |
Not provided
Inclusion Criteria:
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
Life expectancy >= 6 months
Karnofsky status >= 70%
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jasmine Zain, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38838232 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Carmustine | Drug | Given IV |
|
|
| Etoposide | Drug | Given IV |
|
|
| Cytarabine | Drug | Given IV |
|
|
| Melphalan | Drug | Given IV |
|
|
| Autologous Hematopoietic Stem Cell Transplantation | Procedure | Undergo AHCT |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Pharmacological Study | Other | Correlative studies |
|
|
Survival estimates will be calculated using the Kaplan-Meier method. |
| From start of therapy (stem cell infusion) to death from any cause, assessed up to 2 years post-transplant |
| Progression-free survival | Survival estimates will be calculated using the Kaplan-Meier method. | 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 |
| Non-relapse mortality | The cumulative incidence of relapse/progression and non-relapse mortality will be calculated as competing risks using the Gray method. | From start of therapy until non-disease related death, or last follow-up, whichever comes first, assessed up to 2 years post-transplant |
| 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. | From start of therapy (stem cell infusion) to the first observation of disease relapse/progression, assessed up to 2 years post-transplant |
| Absorbed radiation dose to organs assessed by nuclear scan images | Up to day -14 |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002330 | Carmustine |
| D005047 | Etoposide |
| D003561 | Cytarabine |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided