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Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation

This study has been terminated.
(Interim analysis indicated study should be terminated)
Information provided by (Responsible Party):
Baxalta US Inc. Identifier:
First received: November 1, 1999
Last updated: June 26, 2015
Last verified: May 2013

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues.

PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine plus methotrexate with cyclosporine plus T cell depletion for prevention of graft-versus-host disease during peripheral stem cell transplantation in patients who have advanced leukemia or lymphoma who are eligible for transplanted peripheral stem cells from a donor.

Condition Intervention Phase
Graft Versus Host Disease
Drug: cyclosporine
Drug: cyclosporine and methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Official Title: Peripheral Blood Stem Cell Transplantation in Patients With Advanced Malignancies Eligible for Allogeneic Transplantation From Matched Related Donors: A Randomized Study of Cyclosporine/Methotrexate or Cyclosporine/T-Cell Depletion (CD34 Cell Selection) for GVHD Prophylaxis

Resource links provided by NLM:

Further study details as provided by Baxalta US Inc.:

Enrollment: 105
Study Start Date: April 1997
Estimated Study Completion Date: June 2003
Estimated Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Unselected peripheral blood haemopoietic stem cells (PBSC)
Unselected PBSC together with control graft versus host disease (GVHD) prophylaxis - Control
Drug: cyclosporine and methotrexate
Experimental: CD34+ cells isolated from PBSC
CD34+ cells isolated from PBSC using the Isolex 300i system together with cyclosporine
Drug: cyclosporine

Detailed Description:

OBJECTIVES: I. Demonstrate that the graft versus host disease (GVHD) prophylactic regimen consisting of T-cell depletion and cyclosporine results in less toxicity than the control regimen of methotrexate and cyclosporine in recipients of peripheral blood stem cell transplants. II. Monitor safety of the two regimens in order to assure that the treatment regimen dose not result in any increase in serious or unexpected toxicities, does not compromise the efficacy of GVHD prophylaxis, and does not compromise the efficacy of the disease therapy.

OUTLINE: This is a multicenter, controlled, randomized trial. Patients are assigned to high or low risk groups and randomized to the control or treatment arms. Patients are stratified by risk group and by site. Mobilization, apheresis, and successful cryopreservation of the minimum number of CD34 cells for transplant has to be achieved prior to initiating cytoreductive therapy. Following intensive cytoreductive therapy, patients receive either unselected peripheral blood stem cells (PBSC) together with the control graft versus host disease (GVHD) prophylaxis regimen or CD34+ cells isolated from PBSC with cyclosporine. In the control group, GVHD prophylaxis consists of two drug therapies, cyclosporine and methotrexate. The cyclosporine is administered first by IV continuous infusion and then later orally, twice a day, in decreasing increments for 180 days. Methotrexate is administered by IV on days 1, 3, 6, and 11. Cyclosporine is discontinued after day +180 if there is no evidence of GVHD. In the treatment group, GVHD prophylaxis consists of T cell depletion of the transplant product using the Isolex positive selection procedure (Isolex selected CD34+ cells) and cyclosporine. The cyclosporine is administered at the same doses and increments as in the control group. In cases where there still is acute or chronic GVHD, the patient is given the appropriate salvage regimens. Patients are followed monthly for 6 months after transplant, and then for 2 years to monitor relapses.

PROJECTED ACCRUAL: There will be 200 patients accrued (100 in each arm) in this study.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: - Acute lymphocytic leukemia (ALL) with documented chemosensitivity (complete response [CR], partial response [PR], or minor response [MR]) in first or second remission, first or second relapse, or high risk ALL with Ph positive 9/22 translocation; OR - Acute myelogenous leukemia (AML) with documented chemosensitivity (CR, PR, or MR) in first or second remission, or first or second relapse; OR - Chronic myelogenous leukemia (CML), chronic or accelerated, that is not in blast crisis; OR - Hodgkin's disease or non-Hodgkin's lymphoma with documented chemosensitivity in first or second relapse Consenting human lymphocyte antigen (HLA)-identical related donor required No active central nervous system (CNS) or skin leukemia involvement No disease that requires additional mediastinal radiation

PATIENT CHARACTERISTICS: Age: 18-55 Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 times normal serum glutamate oxalo-acetate transaminase (SGOT) less than 2 times normal Renal: Creatinine less than 1.5 times normal Cardiovascular: Left ventricular ejection fraction at rest at least 40% or within normal range Pulmonary: diffusing capacity of the lung for carbon monoxide (DLCO) greater than 45% of predicted or within normal range Other: HIV negative At least 2 weeks since any active infection requiring intravenous treatment with antifungal, antibacterial or antiviral agents with the exception of coagulase negative staphylococcal line infection No coexisting medical problems that would significantly increase the risk of the transplant procedure Not pregnant or nursing

PRIOR CONCURRENT THERAPY: No more that 2 prior therapy regimens Biologic therapy: No prior autologous or allogeneic bone marrow or peripheral blood stem cell transplant Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy subject to dose requirements Surgery: Not specified Other: At least 2 weeks since intravenous treatment with antifungal, antibacterial or antiviral agents, except for treatment of coagulase negative staphylococcal infection of an IV or central line

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Please refer to this study by its identifier: NCT00003056

United States, California
Los Angeles, California, United States
United States, Florida
Jacksonville, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Lawrence, Kansas, United States
United States, Minnesota
St. Paul, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
St. Louis, Missouri, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Texas
San Antonio, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Australia, South Australia
Adelaide, South Australia, Australia
Sponsors and Collaborators
Baxalta US Inc.
Study Chair: John M. McCarty, MD Massey Cancer Center
  More Information

Responsible Party: Baxalta US Inc. Identifier: NCT00003056     History of Changes
Other Study ID Numbers: BAXTER-302302
CDR0000065709 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: November 1, 1999
Last Updated: June 26, 2015

Keywords provided by Baxalta US Inc.:
recurrent adult Hodgkin lymphoma
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
graft versus host disease
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Graft vs Host Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents
Calcineurin Inhibitors processed this record on April 28, 2017