Clinical trial · Interventional
Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma
Y Zevalin, BEAM and Rituximab In Autologous Stem Cell Transplantation (ASCT) For Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to see if high-dose chemotherapy (BEAM) and rituximab, given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells is safe. Another goal is to learn if this treatment can help decrease the chances of the cancer coming back.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-C | Drug | Cytarabine | ALIAS |
| BCNU | Drug | Carmustine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| In Zevalin | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Rituxan | Drug | Rituximab | ALIAS |
| Stem Cell Infusion | Procedure | — | UNRESOLVED |
| VP -16 | Drug | Etoposide | ALIAS |
| Y Zevalin | Drug | — |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Y Zevalin + BEAM
- description
- Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation. G-CSF 5 mg/kg given daily starting Day 0 till recovery of granulocytes of 4.0 \* 109/L.
- interventionNames
- Drug: Y Zevalin
- Drug: In Zevalin
- Drug: Rituxan
- Drug: BCNU
- Drug: VP -16
- Drug: Ara-C
- Drug: Melphalan
- Procedure: Stem Cell Infusion
- Drug: G-CSF
Primary outcomes (2)
- measure
- Overall Survival Median
- timeFrame
- Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Relapsed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) (demonstrated in lymph nodes or bone marrow), chemosensitive (at least Partial Remission (PR)). 2. No anti-cancer therapy started within three weeks, prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy. No prior Rituximab within three weeks of starting therapy. 3. No prior radioimmunoconjugate therapy. 4. If patients had prior radiation, this should have not involved more than 25% of the bone marrow. 5. An IRB-approved signed informed consent. 6. Age: 18 to 65 years of age. 7. Acceptable hematologic status within two weeks prior to patient registration, including: Absolute neutrophil count (\[segmented neutrophils + bands\] \* total white blood count (WBC)) \> 1,500/mm3. Platelet counts \> 100,000/mm3. 8. Patients determined to have \<10% bone marrow involvement with lymphoma within four weeks before stem cell collection as defined by bilateral aspirates and biopsies. 9. Prestudy performance status of 0, 1, or 2 according to the World Health Organization (WHO). 10. Female patients included must not be pregnant or lactating. 11. Men and women or reproductive potential who are following acceptable birth control methods (as determined by the treating physician, however abstinence is not an acceptable method). 12. Patients who have previously been treated on Phase II drugs can be included if no long-term toxicity is expected, and the patient has been off the drug for four or more weeks with no significant post treatment toxicities observed 13. Patients should have at least 4 \* 106 CD34+/kg peripheral stem cells collected. Whenever possible, 1 to 2 \* 106 CD34+/kg, for the first 10 patients and held for 1 year in case of graft failure. If graft failure does not occur in the first 10 patients, backup cells will not be required for subsequent patients. Exclusion Criteria: 1. Patients with impaired bone marrow reserve, as indicated by one or more of the following: Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue Platelet count \< 100,000 cells/mm3 Hypocellular bone marrow Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid) History of failed stem cell collection of \> 4\*106 CD34+/kg 2. Prior radioimmunotherapy. 3. Presence of central nervous system (CNS) lymphoma. 4. Patients with chronic lymphocytic lymphoma. 5. Patients with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related lymphoma. 6. Patients with abnormal liver function: total bilirubin \> 1.5 mg/dl 7. Patients with abnormal renal function: serum creatinine \> 1.6 mg/dl 8. Patients who have received prior external beam radiation therapy to \>25% of active bone marrow (involved field or regional). 9. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives. 10. Corrected carbon monoxide diffusion in the lung (DLCO) \<50% and forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) \< 50% predicted. 11. Cardiac ejection fraction (EF) \< 50% by 2-D Echogram. 12. Pleural effusions. 13. Prior radiation to lungs. 14. Abnormal cytogenetics, filter in situ hybridization (FISH) (-5, -7, 11q23)
References
Publications (2)
- DERIVEDChamoun K, Milton DR, Ledesma C, Young KH, Jabbour EJ, Alatrash G, Anderlini P, Bashir Q, Ciurea SO, Marin D, Molldrem JJ, Olson AL, Oran B, Popat UR, Rondon G, Champlin RE, Gulbis AM, Khouri IF. Allogeneic Transplantation after Myeloablative Rituximab/BEAM +/- Bortezomib for Patients with Relapsed/Refractory Lymphoid Malignancies: 5-Year Follow-Up Results. Biol Blood Marrow Transplant. 2019 Jul;25(7):1347-1354. doi: 10.1016/j.bbmt.2019.02.022. Epub 2019 Mar 1. PMID 30826465
- DERIVEDChahoud J, Sui D, Erwin WD, Gulbis AM, Korbling M, Zhang M, Ahmed S, Alatrash G, Anderlini P, Ciurea SO, Oran B, Fayad LE, Bassett RL Jr, Jabbour EJ, Medeiros LJ, Macapinlac HA, Young KH, Khouri IF. Updated Results of Rituximab Pre- and Post-BEAM with or without 90Yttrium Ibritumomab Tiuxetan during Autologous Transplant for Diffuse Large B-cell Lymphoma. Clin Cancer Res. 2018 May 15;24(10):2304-2311. doi: 10.1158/1078-0432.CCR-17-3561. Epub 2018 Feb 23. PMID 29476021