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| Sponsor: | Masonic Cancer Center, University of Minnesota |
|---|---|
| Information provided by (Responsible Party): | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00305682 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. An umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by an umbilical cord blood transplant, cyclosporine, and mycophenolate mofetil works in treating patients with hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: umbilical cord blood transplantation Radiation: total-body irradiation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen |
Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria.
Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level
Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria.
Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm 1-Previous Autologous Transplant
Arm 1 - hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycle of multiagent chemotherapy within the last 3 months previous to umbilical cord blood transplant (UCBT).
|
Drug: cyclophosphamide
Cyclophosphamide 50mg/kg x 1 to be administered with high volume fluid flush and mesna (MT(S) 1996-02) on day -6.
Other Name: Cytoxan
Drug: cyclosporine
Patients will receive cyclosporine A (CSA) therapy beginning on day -3 maintaining a trough level between 200 and 400 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours.
Other Name: CSA
Drug: fludarabine phosphate
Fludarabine 40 mg/m2/day intravenously (IV) x 5 days, total dose 200 mg/m2
Other Name: Fludara
Drug: mycophenolate mofetil
Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
Other Name: MMF
Procedure: umbilical cord blood transplantation
One or 2 UCB units may be infused to achieve the required cell dose.
Other Name: UCBT
Radiation: total-body irradiation
Administered Day -1, 200 cGy
Other Name: TBI
|
|
Active Comparator: Arm 2 - No Previous Autologous Transplant
Arm 2 - hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplant (UCBT), and who should receive anti-thymocyte globulin (ATG) as part of their conditioning regimen.
|
Biological: anti-thymocyte globulin
Equine ATG dose is 15 mg/kg intravenously (IV) every 12 hours for 6 doses on days -6, - 5, and -4.
Other Name: ATGAM(R)
Drug: cyclophosphamide
Cyclophosphamide 50mg/kg x 1 to be administered with high volume fluid flush and mesna (MT(S) 1996-02) on day -6.
Other Name: Cytoxan
Drug: cyclosporine
Patients will receive cyclosporine A (CSA) therapy beginning on day -3 maintaining a trough level between 200 and 400 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours.
Other Name: CSA
Drug: fludarabine phosphate
Fludarabine 40 mg/m2/day intravenously (IV) x 5 days, total dose 200 mg/m2
Other Name: Fludara
Drug: mycophenolate mofetil
Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
Other Name: MMF
Procedure: umbilical cord blood transplantation
One or 2 UCB units may be infused to achieve the required cell dose.
Other Name: UCBT
Radiation: total-body irradiation
Administered Day -1, 200 cGy
Other Name: TBI
|
|
Active Comparator: Arm 3 - Refractory Leukemia/Lymphoma
Arm 3 - patients with refractory leukemia or lymphoma who have been rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
|
Drug: cyclophosphamide
Cyclophosphamide 50mg/kg x 1 to be administered with high volume fluid flush and mesna (MT(S) 1996-02) on day -6.
Other Name: Cytoxan
Drug: cyclosporine
Patients will receive cyclosporine A (CSA) therapy beginning on day -3 maintaining a trough level between 200 and 400 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours.
Other Name: CSA
Drug: fludarabine phosphate
Fludarabine 40 mg/m2/day intravenously (IV) x 5 days, total dose 200 mg/m2
Other Name: Fludara
Drug: mycophenolate mofetil
Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
Other Name: MMF
Procedure: umbilical cord blood transplantation
One or 2 UCB units may be infused to achieve the required cell dose.
Other Name: UCBT
Radiation: total-body irradiation
Administered Day -1, 200 cGy
Other Name: TBI
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized study. Patients are stratified according to disease (acute myeloid leukemia, myelodysplastic syndromes, chronic myelogenous leukemia [CML] in first chronic phase and second chronic phase [CP2] after myeloid blast crisis vs acute lymphoblastic leukemia, CML CP2 post lymphoid blast crisis, lymphoblastic lymphoma, and Burkitt's lymphoma vs large cell B- and T-cell lymphomas and mantle cell lymphoma vs chronic lymphocytic leukemia, marginal zone B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and prolymphocytic leukemia vs Hodgkin's lymphoma and multiple myeloma).
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of one of the following advanced hematologic malignancies:
Acute leukemia in remission by morphology (< 5% blasts) OR cytogenetic relapse or persistent disease without morphologic relapse*
Acute myeloid leukemia, meeting 1 of the following criteria:
High-risk disease as evidenced by 1 of the following criteria:
Acute lymphoblastic leukemia/lymphoma, meeting 1 of the following criteria:
High-risk disease in first CR, as evidenced by 1 of the following:
Chronic myelogenous leukemia
Myelodysplastic syndromes (MDS)
Large cell lymphoma*, Hodgkin's lymphoma*, or multiple myeloma, meeting 1 of the following criteria:
Lymphoplasmacytic lymphoma, mantle cell lymphoma*, or prolymphocytic leukemia
Chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone B-cell lymphoma, or follicular lymphoma, meeting 1 of the following criteria:
Burkitt Lymphoma
Stable disease allowed provided the largest residual nodal mass is approximately < 5 cm
Must be ineligible for autologous transplantation due to one of the following criteria:
No evidence of progressive disease by imaging modalities or biopsy
Umbilical cord blood graft must match at 4-6 HLA-A, B, DRB1 antigens
Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance > 40 mL/min (pediatrics)
Exclusion Criteria:
Contacts and Locations| Contact: Claudio Brunstein, MD | 612-625-3918 | bruns072@umn.edu |
| Contact: Timothy Krepski | 612-273-2800 | tkrepsk1@fairview.org |
| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| Principal Investigator: | Claudio G. Brunstein, MD, PhD | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00305682 History of Changes |
| Other Study ID Numbers: | 2005LS036, UMN-MT-2005-02, UMN-0507M70121 |
| Study First Received: | March 21, 2006 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Neoplasms Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders |
Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Antilymphocyte Serum Cyclophosphamide Cyclosporins Cyclosporine Fludarabine monophosphate Mycophenolate mofetil Fludarabine |