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

Study Description

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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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Biogen

Investigators

Principal Investigator:	Issa F. Khouri, MD	M.D. Anderson Cancer Center

More Information

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Additional Information:

The University of Texas M.D.Anderson Cancer Center official website 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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