Clinical trial · Interventional
Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies
Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies
NCT00476229CI-TRIAL-00007773completedN/AResults 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)
Primary Objective: 1\. To determine whether the primary endpoint: the composite success rate, defined as the proportion of patients who are alive at day 100; and are without grade 3-4 Graft versus Host Disease (GVHD); and are without grade 4 toxicity (unrelated to infection); and have engrafted, is likely to be at least 40%. Secondary Objectives: 1. To determine the cumulative incidence of chronic graft versus host disease. 2. To determine the overall and disease free survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral Blood Stem Cell Infusion | Procedure | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Thymoglobulin | Drug | — | UNRESOLVED |
| Total Lymphoid Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation + Chemotherapy + BSCT
- description
- Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
- interventionNames
- Drug: Thymoglobulin
- Radiation: Total Lymphoid Irradiation
- Procedure: Peripheral Blood Stem Cell Infusion
- Drug: Rituximab
Primary outcomes (1)
- measure
- Composite Success Rate
- timeFrame
- Baseline to Day 100, assessment at Day 100
- description
- Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age up to 70 years. * Patients with lymphoid malignancies (primary refractory or recurrent) beyond first remission or unresponsive to therapy and not eligible for protocols of higher priority. Patients should have had at least a partial remission or have stable disease with prior chemotherapy. Patients with bulky disease (greatest dimension \> 5 cm by radiographic or clinical examination are not eligible). * Adequate renal function, as defined by serum creatinine \<1.8 mg/dL. * Adequate hepatic function, as defined by SGPT \<3 times upper limit of normal; serum bilirubin and alkaline phosphatase \<3 times upper limit of normal. * Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) \>35% of expected corrected for hemoglobin. Exceptions may be allowed for patients with pulmonary involvement after discussing with Principal Investigator. * Adequate cardiac function with left ventricular ejection fraction \>35%. No uncontrolled arrhythmias or symptomatic cardiac disease. * Zubrod performance status \<2 * Patients must have an human leukocyte antigens (HLA) matched, or one A, B, C, DR, or DQ mismatched related or unrelated donor (by high resolution typing). Donor must be willing to donate peripheral blood progenitor cells. * Patient should be willing to participate in the study by providing written consent. * Negative beta human chorionic gonadotrophin (hCG) test in a woman of child bearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization). Exclusion Criteria: * Patients with active central nervous system (CNS) disease. * Evidence of acute or chronic active hepatitis or cirrhosis. * Uncontrolled infection, including Hepatitis B, C, Human immunodeficiency virus (HIV) or human T-cell lymphotropic virus type 1 (HTLV-1) infection.
References
Publications (0)
Data not yet available
No reference posted for this study.