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Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048737
Recruitment Status : Completed
First Posted : November 8, 2002
Results First Posted : June 13, 2013
Last Update Posted : June 13, 2013
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
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.
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:
  • Fludarabine phosphate
  • Fludara

Drug: Cyclophosphamide
750 mg/m^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals
Other Names:
  • Cytoxan
  • Neosar

Procedure: Allogeneic Stem Cell Transplantation
Allogeneic stem cell transplantation 2 days after chemotherapy
Other Name: ASCT

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. 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.
  2. Measurable disease.
  3. Age 18-70 years, expected survival >/= 3 months, performance status 0 to 2.
  4. Availability of a matched related donor.
  5. </+ 50% bone marrow involvement.
  6. CLL with </+ 10,000 circulating lymphocytes.
  7. Availability of a matched related or unrelated donor.

Exclusion Criteria:

  1. Prior myeloablative therapies or radioimmunotherapy.
  2. Prior external beam radiation therapy to >25% of active bone marrow.
  3. Prior therapy with 90Y Zevalin or Campath.
  4. CNS lymphoma, HIV, HTLV-1 positivity, some creatinine >1.6 mg/dl or serum bilirubin >1.5 mg/dl.
  5. Pregnancy or lactation.
  6. Symptomatic pulmonary or cardiac disease.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00048737

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United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Issa F. Khouri, MD M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00048737    
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:
Lymphoid Malignancy
Fludarabine Phosphate
Indium Zevalin
90Y Zevalin
B-cell Lymphoma
CD-20-positive B-cell Lymphoma
Chronic Lymphocytic Leukemia
Allogeneic Stem Cell Transplantation
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents