Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00827099|
Recruitment Status : Terminated (Unacceptable morbidity & mortality)
First Posted : January 22, 2009
Results First Posted : August 3, 2011
Last Update Posted : March 23, 2012
RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant together with fludarabine, melphalan, and antithymocyte globulin works in treating patients with hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Biological: anti-thymocyte globulin Drug: fludarabine phosphate Drug: Melphalan Drug: mycophenolate mofetil Drug: tacrolimus Procedure: umbilical cord blood transplantation||Phase 2|
- To evaluate the 100-day transplant-related (non-relapse) mortality in patients with hematologic malignancies undergoing reduced-intensity conditioning comprising fludarabine phosphate, melphalan, and anti-thymocyte globulin followed by sequential umbilical cord blood transplantation (UCBT) from 2 partially-matched unrelated donors.
- To evaluate the 12-month transplant-related (non-relapse) mortality.
- To evaluate the days to neutrophil engraftment (ANC > 500/mm³).
- To evaluate the days to platelet engraftment (platelet count > 20,000/mm³ [unsupported]).
- To evaluate the risk of acute and chronic graft-vs-host disease.
- To evaluate percent donor chimerism contribution of each cord unit.
- To evaluate relapse rate.
- To evaluate disease-free and overall survival.
- To evaluate transfusion support needed for UCBT recipients.
- Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, melphalan IV over 30-60 minutes on day -2, and anti-thymocyte globulin IV over 4-6 hours on days -4 to -2.
- Transplantation: Patients undergo two sequential umbilical cord blood transplantations on day 0.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously and then orally twice daily beginning on day -1 and continuing until day 60, followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or orally twice daily beginning on day 0 and continuing until day 30, followed by a taper until day 60 in the absence of GVHD.
After completion of study treatment, patients are followed periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transplantation of Two Partially Matched Umbilical Cord Blood Units Following Reduced Intensity Conditioning to Enhance Engraftment and Limit Transplant-Related Mortality in Adults With Hematologic Malignancies|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
- Biological: anti-thymocyte globulin
- Drug: fludarabine phosphate
- Drug: Melphalan
- Drug: mycophenolate mofetil
- Drug: tacrolimus
- Procedure: umbilical cord blood transplantation
umbilical cord blood transplantation
- Number of Participants With 100 Day Transplant-related Mortality (TRM) [ Time Frame: 100 days ]100 Day TRM is death within 100 days from transplant related complications
- Number of Patients That Engrafted Blood Counts by 30 Days After Transplant [ Time Frame: Day 30 ]Number of patients whose Absolute Neutrophil Count (ANC) recovered to >500 x10^3/uL for at least 3 consecutive days after transplant
- Percentage of Donor and Host Chimerism of Each Cord Blood Unit [ Time Frame: day 30, day 60, day 90 ]Evaluate the percentages of donor and host chimerism at multiple times post-transplant including Day 30, Day 60, Day 90 and monthly thereafter if the patient is not considered to have full chimerism.
- Number of Patients Who Experience Acute and Chronic Graft-vs-host Disease After Transplant. [ Time Frame: Day 30 ]Patients will be evaluated regularly for the development of graft versus host disease both acute & chronic.
- Number of Patients Who Experience Disease Relapse Post-transplant [ Time Frame: Day 100, 6 months, 1 year, 18 months, 24 months ]Patients will have routine restaging to assess disease response at Day 100, 6 months, 1 year, 18 months and 24 months. If disease relapse is suspected, the patient will be evaluated at that time.
- Number of Patients Who Survive Following Treatment on This Protocol [ Time Frame: Through Death ]Patients will be followed until death
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): NCT00827099
|United States, Georgia|
|Blood and Marrow Transplant Group of Georgia|
|Atlanta, Georgia, United States, 30342|
|Principal Investigator:||Scott R. Solomon, MD||Blood and Marrow Transplant Group of Georgia|