Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies
Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lymphoma
Started Jun 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 17, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
August 9, 2011
CompletedAugust 7, 2012
August 1, 2012
2.9 years
May 17, 2007
July 13, 2011
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Success Rate
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.
Baseline to Day 100, assessment at Day 100
Study Arms (1)
Radiation + Chemotherapy + BSCT
EXPERIMENTALTotal 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)
Interventions
1.5 mg/kg by vein on Days -11 to -7.
80 cGy daily on days -11 to -7 and -4 to 0.
PBSC infusion administered on day 0.
375 mg/m\^2 by vein on days -13, -6, 1, \& 8. Only those patients whose tumors express CD20 will receive Rituximab.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Genzyme, a Sanofi Companycollaborator
Study Sites (1)
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination due to financial support.
Results Point of Contact
- Title
- Chitra M. Hosing, MD/Associate Professor
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Chitra M. Hosing, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2007
First Posted
May 21, 2007
Study Start
June 1, 2006
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
August 7, 2012
Results First Posted
August 9, 2011
Record last verified: 2012-08