Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Biogen Idec
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00048737

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 I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Cancer Leukemia Lymphoma

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Rituximab Ibritumomab tiuxetan

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Patients with Graft Failure [ Time Frame: At 30 days and 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
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 x 3 Other Names: Fludarabine phosphate Fludara Drug: Cyclophosphamide 750 mg/m^2/day x 3, 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

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 x 3

Other Names:

Fludarabine phosphate
Fludara

Drug: Cyclophosphamide

750 mg/m^2/day x 3, 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

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 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

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:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

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
Last Updated:	January 5, 2012
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:

Neoplasms
Leukemia
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine monophosphate
Rituximab
Fludarabine
Vidarabine
Immunosuppressive Agents

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012