Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 lymphoma
Started Oct 2002
Longer than P75 for phase_1 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 6, 2002
CompletedFirst Posted
Study publicly available on registry
November 8, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
June 13, 2013
CompletedJune 13, 2013
June 1, 2013
9.2 years
November 6, 2002
April 22, 2013
June 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Graft Failure
Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.
100 days
Study Arms (1)
90Y Zevalin in ASCT
EXPERIMENTALAllogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Interventions
Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
30 mg/m\^2/day for 3 days
750 mg/m\^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals
Allogeneic stem cell transplantation 2 days after chemotherapy
Eligibility Criteria
You may qualify if:
- 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.
- Measurable disease.
- Age 18-70 years, expected survival \>/= 3 months, performance status 0 to 2.
- Availability of a matched related donor.
- \</+ 50% bone marrow involvement.
- CLL with \</+ 10,000 circulating lymphocytes.
- Availability of a matched related or unrelated donor.
You may not qualify if:
- Prior myeloablative therapies or radioimmunotherapy.
- Prior external beam radiation therapy to \>25% of active bone marrow.
- Prior therapy with 90Y Zevalin or Campath.
- CNS lymphoma, HIV, HTLV-1 positivity, some creatinine \>1.6 mg/dl or serum bilirubin \>1.5 mg/dl.
- Pregnancy or lactation.
- Symptomatic pulmonary or cardiac disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Biogencollaborator
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Khouri 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: 22586182DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Issa Khouri, MD / Professor
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Issa F. Khouri, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2002
First Posted
November 8, 2002
Study Start
October 1, 2002
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
June 13, 2013
Results First Posted
June 13, 2013
Record last verified: 2013-06