Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation
|
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. |
| ClinicalTrials.gov Identifier: NCT00003056 |
|
Recruitment Status :
Terminated
(Interim analysis indicated study should be terminated)
First Posted : May 24, 2004
Last Update Posted : May 6, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia Lymphoma Graft Versus Host Disease | Drug: cyclosporine Drug: cyclosporine and methotrexate | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 105 participants |
| 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 |
| Actual Study Start Date : | April 1, 1997 |
| Actual Primary Completion Date : | June 1, 2003 |
| Actual Study Completion Date : | June 1, 2003 |
| Arm | Intervention/treatment |
|---|---|
|
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 |
- Time to neutrophil engraftment [ Time Frame: Month 1, post-transplant ]
- Time to neutrophil engraftment [ Time Frame: Month 2, post-transplant ]
- Time to neutrophil engraftment [ Time Frame: Month 3, post-transplant ]
- Time to neutrophil engraftment [ Time Frame: Month 4, post-transplant ]
- Time to neutrophil engraftment [ Time Frame: Month 5, post-transplant ]
- Time to neutrophil engraftment [ Time Frame: Month 6, post-transplant ]
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.
| 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
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 ClinicalTrials.gov identifier (NCT number): 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 | |
| Saint Paul, Minnesota, United States | |
| United States, Missouri | |
| Kansas City, Missouri, United States | |
| Saint 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 | |
| Study Director: | Study Director | Takeda |
| Responsible Party: | Baxalta now part of Shire |
| ClinicalTrials.gov Identifier: | NCT00003056 |
| Other Study ID Numbers: |
BAXTER-302302 MCV-CCHR-9703-2A CDR0000065709 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-G97-1311 |
| First Posted: | May 24, 2004 Key Record Dates |
| Last Update Posted: | May 6, 2021 |
| Last Verified: | May 2021 |
|
recurrent adult diffuse small cleaved cell lymphoma adult acute myeloid leukemia in remission recurrent grade 2 follicular lymphoma accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission recurrent grade 1 follicular lymphoma recurrent adult lymphoblastic lymphoma recurrent marginal zone lymphoma chronic phase chronic myelogenous leukemia recurrent small lymphocytic lymphoma recurrent grade 3 follicular lymphoma recurrent adult Hodgkin lymphoma |
recurrent adult acute lymphoblastic leukemia recurrent adult immunoblastic large cell lymphoma graft versus host disease recurrent adult diffuse mixed cell lymphoma recurrent mantle cell lymphoma splenic marginal zone lymphoma recurrent adult acute myeloid leukemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue recurrent adult diffuse large cell lymphoma nodal marginal zone B-cell lymphoma recurrent adult Burkitt lymphoma |
|
Lymphoma Leukemia Graft vs Host Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclosporine Methotrexate Cyclosporins Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites 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 |