Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00048737
First received: November 6, 2002
Last updated: June 11, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Leukemia |
Drug: Zevalin Radioimmunotherapy Drug: Rituximab Drug: Fludarabine Drug: Cyclophosphamide Procedure: Allogeneic Stem Cell Transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Ibritumomab tiuxetan
Genetic and Rare Diseases Information Center resources:
B-cell Lymphomas
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
Lymphosarcoma
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Number of Participants With Graft Failure [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.
| Enrollment: | 70 |
| Study Start Date: | October 2002 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 90Y Zevalin in ASCT
Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
|
Drug: Zevalin Radioimmunotherapy
Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Other Name: 90Y Zevalin
Drug: Rituximab
250 mg/m^2 on day 1 and day 8
Other Name: Rituxan
Drug: Fludarabine
30 mg/m^2/day for 3 days
Other Names:
Drug: Cyclophosphamide
750 mg/m^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals
Other Names:
Procedure: Allogeneic Stem Cell Transplantation
Allogeneic stem cell transplantation 2 days after chemotherapy
Other Name: ASCT
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048737
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048737
Locations
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Biogen Idec
Investigators
| Principal Investigator: | Issa F. Khouri, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided by M.D. Anderson Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00048737 History of Changes |
| Other Study ID Numbers: | ID01-233 |
| Study First Received: | November 6, 2002 |
| Results First Received: | April 22, 2013 |
| Last Updated: | June 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Leukemia Lymphoma Lymphoid Malignancy Cyclophosphamide Cytoxan Neosar Fludarabine Fludarabine Phosphate Fludara Rituximab Rituxan |
Zevalin Indium Zevalin 90Y Zevalin CD-20-positive B-cell Lymphoma CD-20-positive B-cell Lymphoma NHL CLL Chronic Lymphocytic Leukemia Allogeneic Stem Cell Transplantation ASCT |
Additional relevant MeSH terms:
|
Cyclophosphamide Fludarabine Fludarabine phosphate Alkylating Agents Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antineoplastic Agents, Alkylating |
Antirheumatic Agents Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015