Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
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ClinicalTrials.gov Identifier: NCT00048737 |
Recruitment Status
:
Completed
First Posted
: November 8, 2002
Results First Posted
: June 13, 2013
Last Update Posted
: June 13, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma Leukemia | Drug: Zevalin Radioimmunotherapy Drug: Rituximab Drug: Fludarabine Drug: Cyclophosphamide Procedure: Allogeneic Stem Cell Transplantation | Phase 1 Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies |
Study Start Date : | October 2002 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 90Y Zevalin in ASCT
Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
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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
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- Number of Participants With Graft Failure [ Time Frame: 100 days ]Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048737
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Issa F. Khouri, MD | M.D. Anderson Cancer Center |
Additional Information:
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 |
First Posted: | November 8, 2002 Key Record Dates |
Results First Posted: | June 13, 2013 |
Last Update Posted: | June 13, 2013 |
Last Verified: | June 2013 |
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:
Lymphoma Leukemia Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Fludarabine phosphate Rituximab Fludarabine Antibodies, Monoclonal Vidarabine |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents |