Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer
|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: NCT00134017|
Recruitment Status : Completed
First Posted : August 24, 2005
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Drug: Busulfan Drug: Cyclophosphamide||Phase 2|
- Determine the optimal dose of post-transplant immunosuppression comprising high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil administered after myeloablative conditioning chemotherapy comprising busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation in patients with high-risk hematologic malignancies.
- Determine the incidence and severity of acute graft-versus-host disease in patients treated with this regimen.
- Determine other toxic effects of this regimen in these patients.
- Determine immune reconstitution in patients treated with this regimen.
- Determine disease control in patients treated with this regimen.
OUTLINE: This is a pilot study. Patients are stratified according to age (≤ 19 years old vs > 19 years old).
- Myeloablative conditioning chemotherapy: Patients receive busulfan IV or orally 4 times daily on days -7 to -4 OR days -6 to -3 and cyclophosphamide IV over 1 hour once daily on days -3 to -1 OR days -2 and -1.
- Allogeneic bone marrow transplantation: Patients undergo allogeneic bone marrow transplantation on day 0.
- Immunosuppression therapy: Patients receive high-dose cyclophosphamide IV over 1 hour on days 3 and 4.
After completion of study transplantation, patients are followed at 30 and 60 days, 6 months, 1 year, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HLA Matched Related and Unrelated Bone Marrow Transplantation With Busulfan/Cyclophosphamide and Post Transplantation Cyclophosphamide for Hematological Malignancies|
|Actual Study Start Date :||June 2004|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Experimental: Bone marrow transplant
Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis
Days -7 to -4: 4 mg/kg PO daily OR 3.2 mg/kg IV daily OR 160 mg/m^2 daily (for pediatric recipients)
Days -3, -2, +3, +4: 50 mg/kg IV daily
- Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD) [ Time Frame: Day 100 ]Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).
- Days to Engraftment [ Time Frame: Up to one year ]Median number of days to neutrophil and platelet engraftment.
- Chimerism [ Time Frame: Day 30, Day 60 ]Number of patients who achieved 100% donor chimerism.
- Non-relapse Mortality [ Time Frame: Day 100, 2 years ]Percentage of participants who died for BMT-related reasons.
- Relapse [ Time Frame: 2 years ]Percentage of participants who developed relapse or progressive disease.
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): NCT00134017
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||Leo Luznik, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|