Clinical trial · Interventional
Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
NCT00048737CI-TRIAL-00010706completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 low intensity chemotherapy given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells from a donor can increase the length of remission in patients with leukemia and lymphoma. The safety of this treatment will also be studied.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Zevalin Radioimmunotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 90Y Zevalin in ASCT
- description
- Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
- interventionNames
- Drug: Zevalin Radioimmunotherapy
- Drug: Rituximab
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Procedure: Allogeneic Stem Cell Transplantation
Primary outcomes (1)
- measure
- Number of Participants With Graft Failure
- timeFrame
- 100 days
- description
- Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients in relapse or considered at high risk for relapse or refractory CD-20-positive B-cell NHL or CLL. Patients considered for high risk of relapse are patients who do not achieve complete response (CR) with frontline chemotherapy, CLL is Richter's and CLL with high risk chromosomal abnormalities. 2. Measurable disease. 3. Age 18-70 years, expected survival \>/= 3 months, performance status 0 to 2. 4. Availability of a matched related donor. 5. \</+ 50% bone marrow involvement. 6. CLL with \</+ 10,000 circulating lymphocytes. 7. Availability of a matched related or unrelated donor. Exclusion Criteria: 1. Prior myeloablative therapies or radioimmunotherapy. 2. Prior external beam radiation therapy to \>25% of active bone marrow. 3. Prior therapy with 90Y Zevalin or Campath. 4. CNS lymphoma, HIV, HTLV-1 positivity, some creatinine \>1.6 mg/dl or serum bilirubin \>1.5 mg/dl. 5. Pregnancy or lactation. 6. Symptomatic pulmonary or cardiac disease.
References
Publications (1)
- DERIVEDKhouri IF, Saliba RM, Erwin WD, Samuels BI, Korbling M, Medeiros LJ, Valverde R, Alousi AM, Anderlini P, Bashir Q, Ciurea S, Gulbis AM, de Lima M, Hosing C, Kebriaei P, Popat UR, Fowler N, Neelapu SS, Samaniego F, Champlin RE, Macapinlac HA. Nonmyeloablative allogeneic transplantation with or without 90yttrium ibritumomab tiuxetan is potentially curative for relapsed follicular lymphoma: 12-year results. Blood. 2012 Jun 28;119(26):6373-8. doi: 10.1182/blood-2012-03-417808. Epub 2012 May 14. PMID 22586182