Donor Stem Cell Transplant in Treating Patients With Previously Treated Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00612716|
Recruitment Status : Recruiting
First Posted : February 12, 2008
Last Update Posted : January 5, 2018
RATIONALE: Giving chemotherapy, such as cyclophosphamide and busulfan, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells from bone marrow or umbilical cord blood may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving methotrexate and cyclosporine after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm||Drug: busulfan Drug: cyclophosphamide Biological: Stem cell infusion Radiation: Total body irradiation||Phase 2|
- Determine if allogeneic stem cell transplantation using unrelated matched or related haploidentical donor bone marrow or unrelated matched cord blood results in timely, complete, and durable engraftment in patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic leukemia.
- Determine the incidence and grade of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine if the augmented graft-versus-tumor effect accompanying unrelated or partially matched donor allogeneic transplant reduces the incidence of relapse in these patients.
- Preparative regimen: Patients receive cyclophosphamide IV over 2 hours on days -7 and -6 and undergo total-body irradiation (TBI) twice daily on days -4 to -1. Patients who are unable to undergo TBI receive busulfan IV or orally 4 times daily on days -9 to -6 and cyclophosphamide IV over 2 hours on days -5 to -2.
- Stem cell transplantation: All patients undergo unrelated matched bone marrow or umbilical cord blood transplantation or partially matched related allogeneic bone marrow transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive GVHD prophylaxis comprising methotrexate and cyclosporine. Patients may be enrolled in other protocols directed towards GVHD prophylaxis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Unrelated or Partially Matched Allogeneic Donor Stem Cells for Lymphoma, Myeloma, and Chronic Lymphocytic Leukemia|
|Actual Study Start Date :||October 6, 1999|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2021|
Experimental: Allogeneic Transplantation
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
For those not eligible for total body irradiation: busulfan 4 mg/kg/day orally (1 mg/kg orally every 6 hrs) on Days -9 through -6.
Other Name: Busulfex
Cyclophosphamide 60 mg/kg/day on days -7 and -6. For patients not eligible for total body irradiation: cytoxan 50 mg/kg intravenously (IV) on days -5 through -2.
Other Name: Cytoxan
Biological: Stem cell infusion
Infused on Day 0
Radiation: Total body irradiation
165 cGy morning and evening on days -4 through -1.
Other Name: TBI
- Engraftment failure [ Time Frame: 3 Months ]Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
- Time to engraftment [ Time Frame: 3 Months ]Time to first of 3 consecutive days with absolute neutrophil count (ANC) > 500/:l. Time to platelet transfusion independence (platelets > 20,000 with no transfusions for the following 7 days). Time to red blood cell (RBC) transfusion independence (Hemoglobin > 9.0 with no transfusions for the following 15 days).
- Incidence and severity of acute graft-versus-host disease [ Time Frame: Day 100 ]Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
- Persistence or relapse of malignancy [ Time Frame: 3 Years ]the return of disease after its apparent recovery/cessation.
- Overall Survival [ Time Frame: Annually ]
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive.
- Incidence and severity of chronic GVHD. [ Time Frame: 1 Year ]Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
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): NCT00612716
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Daniel J. Weisdorf, MD 612-624-0123 firstname.lastname@example.org|
|Principal Investigator: Daniel Weisdorf, M.D.|
|Principal Investigator:||Daniel J. Weisdorf, MD||Masonic Cancer Center, University of Minnesota|