NCT01476839CompletedPhase 1
Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma
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"
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 18 Nov 2011
- Start date
- 13 Feb 2013
- Primary completion date
- 24 Jul 2021
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Hodgkin lymphoma
- NCT number
- NCT01476839
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 25
- From 13 Feb 2013 to the primary completion date, 24 Jul 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Positive human immunodeficiency virus antibody
- 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
Other illness
- Active hepatitis B or C viral infection or hepatitis B surface antigen positive
- 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)
Lab values
- Lymphocyte-predominant Hodgkin lymphoma
Age
- 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
Other
- 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)
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.