Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin s Lymphoma
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|ClinicalTrials.gov Identifier: NCT01468311|
Recruitment Status : Active, not recruiting
First Posted : November 9, 2011
Results First Posted : May 25, 2017
Last Update Posted : May 25, 2018
|First Submitted Date ICMJE||November 5, 2011|
|First Posted Date ICMJE||November 9, 2011|
|Results First Submitted Date||April 17, 2017|
|Results First Posted Date||May 25, 2017|
|Last Update Posted Date||May 25, 2018|
|Actual Study Start Date ICMJE||October 11, 2011|
|Actual Primary Completion Date||November 16, 2014 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT01468311 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin s Lymphoma|
|Official Title ICMJE||Phase I/II Trial of Yttrium-90-labeled Daclizumab (Anti-CD25) Radioimmunotherapy With High-dose BEAM Chemotherapy and Autologous Hematopoietic Stem Cell Rescue in Recurrent and Refractory Hodgkin s Lymphoma|
- To see if yttrium-90 daclizumab, high-dose chemotherapy, and stem cell transplants can treat HL that has not responded to earlier treatments.
- Individuals at least 18 years of age who have Hodgkins lymphoma that has not responded to chemotherapy.
Phase I Primary Objectives:
Phase II Primary Objectives:
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Study Arms||Experimental: Yttrium-90-labeled Daclizumab + Chemotherapy
Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Estimated Study Completion Date||September 1, 2021|
|Actual Primary Completion Date||November 16, 2014 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
220.127.116.11 All patients must have a pathologically confirmed diagnosis of classical Hodgkin's lymphoma (HL) as outlined in the World Health Organization (WHO) Classification System of Lymphoid Tumours. Patients with nodular lymphocyte-predominant Hodgkin's lymphoma (HL) (NLPHL) are not eligible.
18.104.22.168 Refractory or relapsed HL patients that are also candidates for auto stem cell transplant (ASCT).
22.214.171.124 At least one adverse prognostic factor: (1) initial relapse less than or equal to 12 months after primary chemotherapy, (2) staged as Ann Arbor Classification initial stage III or IV disease, (3) chemotherapy resistant disease, (4) Failure to achieve a complete response (CR) with cytoreductive chemotherapy or persistent positive (18) fluorodeoxyglucose positron emission tomography (FDGPET) imaging.
126.96.36.199 At least 10% of the cells obtained from lymph node, or extranodal sites must react with anti-cluster of differentiation 25 (CD25) (anti-Tac) on immunofluorescent or immunoperoxidase staining. Because of the high frequency of CD25 positivity of the infiltrating Tcells in HL tumors, patients with CD25-positive infiltrating T cells will be eligible even if their Hodgkin's (Reed-Sternberg) cells are CD25-negative.
188.8.131.52 Measurable disease as defined by the Cheson Response Criteria for Malignant Lymphoma detailed in section 6.2 with at least one lesion greater than or equal to 1.0 cm in longest diameter by computed tomography (CT) scan.
184.108.40.206 Omission of cytotoxic chemotherapy or other systemic therapy of the malignancy for greater than or equal to 4 weeks prior to entry into the trial. Patients must be greater than or equal to 4 weeks since major surgery, radiotherapy, or biotherapy/targeted therapies and recovered from the toxicity of prior treatment to less than or equal to CTC grade 1, exclusive of grade 2 alopecia, fatigue, lymphopenia, cluster of differentiation 4 (CD4)+ circulating T cells, white blood cell (WBC) or bilirubin.
220.127.116.11 Patients must be greater than or equal to 18-years old.
18.104.22.168 Patients must have a life expectancy of greater than 3 months.
22.214.171.124 Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.
126.96.36.199 The patient must have a granulocyte count of at least 1,500/microL and a platelet count of greater than 100,000/microL.
188.8.131.52 Patients must have a creatinine of less than 2.0 mg/dL, or if the patient has a serum creatinine greater than or equal to 2.0, a measured creatinine clearance (Ccr) must be greater than 60 mL/min/1.73m(2).
184.108.40.206 Patients must have a serum alkaline phosphatase, alanine aminotransferase (ALT) serum glutamic oxaloacetic transaminase (SGOT), and aspartate aminotransferase (AST) serum glutamic pyruvic transaminase (SGPT) less than 3 times the upper limit of normal (ULN), unless due to liver or bone involvement by HL. Under these circumstances, serum alkaline phosphatase, SGPT and SGOT must be less than 5 times ULN.
220.127.116.11 Patients must have a total serum bilirubin less than 2.5 times ULN.
18.104.22.168 Patients must have a cardiac ejection fraction greater than 45% on 2D echocardiography or multi-gated acquisition scan (MUGA) obtained within 28 days of study enrollment.
22.214.171.124 Lung diffusion capacity for carbon monoxide (DLCO) greater than 50%, or forced expiratory volume at 1.0 seconds (FEV1.0) greater than 65% of predicted on pulmonary function testing (PFT) obtained within 28 days of study enrollment.
126.96.36.199 Women of childbearing potential must have a negative serum Beta-human chorionic gonadotropin (HCG) pregnancy test at initial screening and within 3 days prior to registration.
188.8.131.52 The effects of (90)Y-daclizumab on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, while receiving treatment and for 4 months after undergoing ASCT. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
184.108.40.206 Patients receiving a stable dose (greater than 4 weeks) of corticosteroid therapy equivalent to 20 mg of prednisone per day or less are eligible.
220.127.116.11 Patients must be able to understand and sign informed consent.
18.104.22.168 Patients who have relapsed from their initial Adriamycin, bleomycin, vinblastine, dacarbazine) ABVD or similar standard treatment regimen and have not received any other chemotherapy or salvage systemic treatment.
22.214.171.124 Patients that have received prior radioimmunotherapy.
126.96.36.199. Patients enrolled on another therapeutic study.
188.8.131.52 Patients that have received prior radioimmunotherapy.
184.108.40.206 Patients that have received a prior autologous or allogeneic stem cell transplant
220.127.116.11.Patients that have received prior radiation to the lung, excluding prior mediastinal
18.104.22.168 Patients with greater than 25% involvement of the bone marrow with HL.
22.214.171.124 Patients with evidence of myelodysplasia, leukemia by morphology, immunostains flow cytometry or abnormal cytogenetics on a bone- marrow aspirate or biopsy. The diagnosis of myelodysplasia will be made by an independent investigator of the Laboratory of Pathology, National Cancer Institute (NCI) taking into consideration the totality of the clinical, pathological, flow cytometric and cytogenetic information described in Appendix E and present in a particular individual s evaluation.
126.96.36.199 Patients with history of central nervous system (CNS) involvement or active CNS involvement by malignancy.
188.8.131.52 Patients with an active second primary cancer will not be eligible. Patients curatively treated for a second cancer greater than 5 years prior to enrollment without a recurrence are eligible. Patients curatively treated for a second primary cancer within the last 5 years with a less than or equal to 5% risk of recurrence are eligible. Patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine cervix will be allowed on study.
184.108.40.206 Patients with serum human anti-human antibody (HAHA) against daclizumab.
220.127.116.11 Patients with human immunodeficiency virus (HIV) infection (antibody positive with positive confirmatory molecular test).
18.104.22.168 Patients who have chronic hepatitis B or hepatitis C.
22.214.171.124 Patients with an uncontrolled serious infection.
126.96.36.199 Pregnant or breastfeeding women.
188.8.131.52 Patients with significant medical comorbidities, including uncontrolled hypertension (diastolic blood pressure (BP) greater than 115 mmHg), unstable angina, congestive heart failure (greater than New York Heart Association (NYHA) class II), poorly controlled diabetes, severe chronic pulmonary disease, coronary angioplasty or myocardial infarction within the last 6 months, or uncontrolled atrial or ventricular cardiac arrhythmias.
184.108.40.206 Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol and the required follow up.
220.127.116.11 Exclusion at the discretion of the principal investigator (PI) or delegate if participation to the study is deemed too risky (e.g. clinically significant pleural or pericardial effusion or ascites with possibly increased radio-toxicity).
|Ages||18 Years to 99 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01468311|
|Other Study ID Numbers ICMJE||120003
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||
|Responsible Party||Thomas Waldmann, M.D., National Institutes of Health Clinical Center (CC)|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2018|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP