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

This study has been completed.
Sponsor:
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
  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:


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:
  • 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

  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:

  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
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

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:
Neoplasms
Leukemia
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine phosphate
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 August 26, 2014