Status:
TERMINATED
Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
Up to 50 years
Phase:
NA
Brief Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system f...
Detailed Description
OBJECTIVES: Primary * To determine the safety (as assessed by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord stem cell transplantation in patients with hematol...
Eligibility Criteria
Inclusion
- Patient and UCB Unit Selection:
- Inclusion Criteria: General (Adults and Pediatrics)
- Only one of the following should be present:
- Acute leukemia (lymphocytic or myeloid or undifferentiated or biphenotypic) in complete remission 2 or beyond
- Acute lymphocytic leukemia, Philadelphia chromosome positive in complete remission 1 or beyond
- Acute myeloid leukemia in complete remission 1 if it has evolved from a myeloproliferative disorder (MPD) or myelodysplastic syndrome (MDS).
- Acute leukemia in complete remission 1 if there is a failure to recover normal blood counts or the development of MDS following induction chemotherapy.
- Therapy related acute leukemia in complete remission 1 or beyond
- Chronic myeloid leukemia (CML) chronic phase-1 (imatinib failures, imatinib intolerance), or any CML beyond first chronic phase
- Myelodysplastic syndromes (Intermediate -1 or higher risk by IPSS)
- Therapy related MDS (irrespective of IPSS)
- Multiple myeloma must have had prior chemotherapy or autologous transplant
- Chronic lymphocytic leukemia must have failed two lines of conventional therapy but still chemosensitive to third line therapy.
- Chemosensitive Non-Hodgkin's lymphoma or Hodgkin's lymphoma in CR or PR after failing induction therapy.
- High risk acute leukemia/lymphoma eg Nk/T cell, HTLV associated leukemia/lymphoma, other T cell lymphoma/leukemia in first best response
- For patients with acute leukemia-they must be in a remission (less than 5% leukemic marrow blasts) at time of study entry.
- Inclusion Criteria (Adults - 18 years or older)
- Karnofsky score of \> 70%
- Estimated creatinine clearance of \> 60 ml/min
- Left ventricular ejection fraction of \>50%
- Pulmonary function test with DLCO, FEV1 and FVC of \>60%
- Total bilirubin and SGOT of \< 3.0 x upper limits of normal
- Note: Age 18- 40 years for adult myeloablative conditioning Age \> 40 -50 years for adult reduced intensity conditioning
- Inclusion Criteria (Pediatrics - 18 years and younger)
- Karnofsky or Lansky score of \> 70%
- Estimated Creatinine clearance of \> 60 ml/min
- Left ventricular ejection fraction of \>50%
- Pulmonary function test with FEV1 and FVC of \>60% (for patients \>6 years of age)
- Total bilirubin and SGOT of \< 3.0 x upper limits of normal
- Note: All pediatric patients will receive myeloablative conditioning
- Inclusion Criteria - Donor Issues
- No available HLA identical or 1 antigen/allele mismatched (Class I-A, B or Class II DR locus) related donor
- Inclusion Criteria: Umbilical Cord Blood Unit-HLA Typing
- At least a HLA 4/6 match (Class I-A, B by low resolution, Class II-DR by high resolution) to recipient
- For double UCB SCT each unit should be at least a 4/6 match (Class I-A,B by low resolution, Class II-DR by high resolution) to recipient, and should be at least a 4/6 match (Class I-A,B by low resolution, Class II-DR by high resolution) to each other
- Inclusion Criteria: Umbilical Cord Blood Unit-Cell dose
- For Single UCB SCT: the unit will have ≥ 3.5 X 107 NC/kg of recipient body weight (For pediatric patients a cell dose ≥ 3.0 X 107 NC/kg of recipient body weight is acceptable). Recipient body weight will be determined as per standard guidelines.
- For Double UCB SCT: (done only if no single UCB unit ≥ 3.5 X 107 NC/kg of recipient body weight is available for adults, and ≥ 3.0 X 107 NC/kg of recipient body weight is available for pediatric patients )
- The larger of the two units (UCB1) will have a minimum cell dose of 2.0 X 107 NC/kg of recipient body weight. The smaller of the two units (UCB2) will have a minimum of 0.5 X 107 NC/kg of recipient body weight.
- The total cell dose UCB1 + UCB2 will be ≥ 2.5 X 107 NC/kg of recipient body weight.
- Adult patients eligible for a double UCB SCT but without an appropriate second UCB unit will be enrolled in the study if their single UCB unit contains ≥ 2.5 x 107 NC/kg recipient body weight.
- Exclusion Criteria
- Organ dysfunction as per standard guidelines. Unable to give informed consent (for adults only)
- Pregnant or lactating
- Sexually active individuals capable of becoming pregnant or causing a pregnancy who are unable or unwilling to use appropriate contraceptives.
- Active use of illicit drugs as evidenced by a positive toxicology screen for a substance not prescribed by a medical professional just prior to initiating the preparative regimen
- Actively smoking as evidenced by a positive nicotine screen just prior to initiating the preparative regimen
- HIV positive
- Patients with other unrelated malignancies will be excluded except:
- diagnosis of skin cancer (squamous cell or basal cell)
- diagnosis of cervical dysplasia (CIN I-III)
- any other malignancy which is currently in remission and was treated with curative intent more than 5 years preceding study entry
- In patients with secondary MDS or secondary acute leukemias-the previous non-hematopoietic neoplasm should be in remission but can be within 5 years of study entry
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00608517
Start Date
September 1 2005
End Date
May 1 2011
Last Update
May 20 2014
Active Locations (4)
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1
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37067-1631
2
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37067-5615
3
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States, 37212
4
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838