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NCT00719849 · REGISTRY CONDITION SEARCH

Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-06-14

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal 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 cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor umbilical cord blood transplant with reduced intensity conditioning works in treating patients with advanced hematological cancer or other disease.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Probability of Survival at 1 Year

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outcome · POSTED

Probability of Survival at 2 Years

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outcome · POSTED

Incidence of Non-relapse Mortality at 6 Months

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outcome · POSTED

Chimerism

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outcome · POSTED

Incidence of Neutrophil Engraftment at Day 42

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outcome · POSTED

Incidence of Platelet Engraftment at 6 Months

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outcome · POSTED

Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100

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outcome · POSTED

Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100

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outcome · POSTED

Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year

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outcome · POSTED

Incidence of Clinically Significant Infections at 6 Months

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outcome · POSTED

Incidence of Clinically Significant Infections at 1 Year

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outcome · POSTED

Incidence of Clinically Significant Infections at 2 Years

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outcome · POSTED

Probability of Progression-free Survival at 1 Year

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outcome · POSTED

Probability of Progression-free Survival at 2 Years

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outcome · POSTED

Incidence of Relapse at 1 Year

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outcome · POSTED

Incidence of Relapse at 2 Years

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Diagnosis of advanced hematologic malignancy or other disease not curable by conventional chemotherapy, including any of the following: * Acute myeloid leukemia in complete remission (CR)\* (as defined by hematologic recovery, \< 5% blasts in the bone marrow by morphology, and a cellularity of \> 15%), meeting one of the following criteria: * In first complete remission (CR1) AND has high-risk disease as evidenced by any of the following: * Preceding myelodysplastic syndromes (MDS) * High-risk cytogenetics (e.g., monosomy 5 or 7, or as defined by referring institution treatment protocol) * Required \> 2 courses of therapy to obtain CR * Erythroblastic or megakaryocytic leukemia * In second CR (CR2) or beyond * Acute lymphoblastic leukemia in CR\* (as defined by hematologic recovery, \< 5% blasts in the bone marrow by morphology, and a cellularity of \> 15%), meeting one of the following criteria: * In CR1 AND has high-risk disease as evidenced by any of the following: * t(9;22), t(1;19), t(4;11), or other MLL rearrangements * Hyplodiploid * Required \> 1 course of therapy to obtain CR * Beyond CR2 * Chronic myelogenous leukemia (CML) * All types are allowed (except refractory blast crisis CML) * Patients in chronic phase CML must have failed or been intolerant to prior imatinib mesylate (Gleevec) or other tyrosine kinase inhibitors * MDS * Any subtype allowed (including refractory anemia \[RA\]) * Severe pancytopenia or complex cytogenetics * Blasts must be \< 5% (if blasts are ≥ 5%, pre-transplant induction therapy is required to reduce blast count to \< 5%) * Large cell lymphoma, Hodgkin lymphoma, or multiple myeloma, meeting one of the following criteria: * Chemotherapy-sensitive disease that has failed prior therapy * Patients with large cell lymphoma or Hodgkin lymphoma must not have progressive disease during salvage therapy (stable disease allowed provided it is non-bulky) * Ineligible for an autologous stem cell transplant * Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, or follicular lymphoma that has progressed after ≥ 2 prior therapies * Patients with bulky disease should be considered for debulking chemotherapy prior to transplant * Patients with refractory disease are eligible provided disease is non-bulky AND an estimated tumor doubling time is ≥ 1 month * Lymphoplasmacytic lymphoma, mantle cell lymphoma, or prolymphocytic leukemia * Chemotherapy-sensitive disease that was previously treated with initial therapy * Patients with mantle cell lymphoma must not have progressive disease during salvage therapy (stable disease allowed provided it is non-bulky) * Mycosis fungoides and Sezary syndrome * Bone marrow failure syndromes, except for Fanconi anemia * Myeloproliferative syndromes NOTE: \*Patients for whom adequate marrow/biopsy specimens can not be obtained to determine remission status by morphologic assessment must have fulfilled criteria of remission (\< 5% blasts by flow cytometry and recovery of peripheral blood counts with no circulating blasts) * Ineligible for autologous stem cell transplant due to any of the following: * Prior autologous stem cell transplant * Inadequate autologous stem cell harvest * Inability to withstand a myeloablative preparative regimen * Clinically aggressive/high-risk disease * No evidence of progressive disease by imaging modalities or biopsy (persistent PET scan activity allowed provided there are no CT scan changes indicating progression) * Acute leukemia that is refractory, persistent, or relapsed (defined as \> 5% blasts in normocellular bone marrow) allowed provided patient was rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy * Patients with stable disease are eligible provided the largest residual nodal mass is approximately \< 5 cm (largest residual mass must represent a 50% reduction and be approximately \< 7.5 cm for patients who have responded to prior therapy) * No active CNS malignancy * Umbilical cord blood (UCB) donor available * UCB graft matched at 4/6 HLA-A, -B, and -DRB1 antigens with the recipient * May include 0-2 antigen mismatches at the A, B, or DRB1 loci * Unit selection based on cryopreserved nucleated cell dose and HLA-A, -B, and -DRB1 using intermediate resolution A, B antigen and DRB1 allele typing * If 2 UCB units are required to reach the target cell dose, each unit must be a 3/6 HLA-A, -B, and -DRB1 antigen match to each other, as well as a 4/6 antigen match to the recipient * No 5-6/6 HLA-A, -B, and -DRB1 matched sibling donor available PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 60-100% OR Lansky PS 50-100% * Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance \> 40 mL/min (pediatrics) * Adult patients with a creatinine \> 1.2 mg/dL or a history of renal dysfunction must have an estimated creatinine clearance of \> 40 mL/min * Not pregnant or nursing * Negative pregnancy test * LVEF ≥ 35% * DLCO \> 30% predicted * No requirement for O\_2 * No decompensated congestive heart failure * No uncontrolled arrhythmia * None of the following liver diseases or conditions: * Fulminant liver failure * Cirrhosis with evidence of portal hypertension or bridging fibrosis * Alcoholic hepatitis * Esophageal varices * History of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time * Ascites related to portal hypertension * Bacterial or fungal abscess * Biliary obstruction * Chronic viral hepatitis with total serum bilirubin \> 3 mg/dL * Symptomatic biliary disease * Recent mold infection (e.g., Aspergillus) allowed provided patient received ≥ 30 days of appropriate treatment AND infection is controlled and cleared by Infectious Disease * No evidence of HIV infection or known HIV-positive serology * No uncontrolled viral or bacterial infection PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 months since prior myeloablative stem cell transplantation
healthy Volunteers
false
maximum Age
69 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months. Refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
    intervention Names
    1. Drug: cyclophosphamide
    2. Drug: cyclosporine
    3. Drug: fludarabine phosphate
    4. Drug: mycophenolate mofetil
    5. Procedure: umbilical cord blood transplantation
    6. Radiation: total body irradiation
    label
    Cyclophosphamide/Fludarabine/TBI
    type
    EXPERIMENTAL
  2. description
    Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: cyclophosphamide
    3. Drug: cyclosporine
    4. Drug: fludarabine phosphate
    5. Drug: mycophenolate mofetil
    6. Procedure: umbilical cord blood transplantation
    7. Radiation: total body irradiation
    label
    Cyclophosphamide/Fludarabine/TBI/ATG
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cyclophosphamide/Fludarabine/TBI/ATG
    description
    30mg/Kg Days -6 to -4
    name
    anti-thymocyte globulin
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Cyclophosphamide/Fludarabine/TBI
    2. Cyclophosphamide/Fludarabine/TBI/ATG
    description
    50 mg/Kg Day -6
    name
    cyclophosphamide
    type
    DRUG
  3. arm Group Labels
    1. Cyclophosphamide/Fludarabine/TBI
    2. Cyclophosphamide/Fludarabine/TBI/ATG
    description
    Patients will receive cyclosporine A (CSA) therapy beginning on Day -3 maintaining a trough level between 250 and 500 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.
    name
    cyclosporine
    type
    DRUG
  4. arm Group Labels
    1. Cyclophosphamide/Fludarabine/TBI
    2. Cyclophosphamide/Fludarabine/TBI/ATG
    description
    40mg/m2 Days -6 to -2
    name
    fludarabine phosphate
    type
    DRUG
  5. arm Group Labels
    1. Cyclophosphamide/Fludarabine/TBI
    2. Cyclophosphamide/Fludarabine/TBI/ATG
    description
    1 gram every 8 hours for patients who are ≥ 40 kg. Pediatric patients (\<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours. Stop MMF at Day +30 or 7 days after engraftment, whichever day is later, if no acute GVHD.
    name
    mycophenolate mofetil
    type
    DRUG
  6. arm Group Labels
    1. Cyclophosphamide/Fludarabine/TBI
    2. Cyclophosphamide/Fludarabine/TBI/ATG
    description
    Single or double unit umbilical cord blood transplant
    name
    umbilical cord blood transplantation
    type
    PROCEDURE
  7. arm Group Labels
    1. Cyclophosphamide/Fludarabine/TBI
    2. Cyclophosphamide/Fludarabine/TBI/ATG
    description
    200 cGy Day -1
    name
    total body irradiation
    type
    RADIATION
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
13
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Kaplan-Meier estimate of the probability of survival at 1 year
    measure
    Probability of Survival at 1 Year
    time Frame
    1 year post transplant
secondary Outcomes
  1. description
    Kaplan-Meier estimate of the probability of survival at 2 years
    measure
    Probability of Survival at 2 Years
    time Frame
    2 years post transplant
  2. description
    Number of Participants with Non-relapse Mortality at 6 Months
    measure
    Incidence of Non-relapse Mortality at 6 Months
    time Frame
    6 months post transplant
  3. description
    Count of participants who experienced dominance of one cord blood unit (defined by \>or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant.
    measure
    Chimerism
    time Frame
    7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant
  4. description
    Number of participants with neutrophil engraftment at day 42
    measure
    Incidence of Neutrophil Engraftment at Day 42
    time Frame
    Day 42 post transplant
  5. description
    Number of participants with platelet engraftment at 6 months
    measure
    Incidence of Platelet Engraftment at 6 Months
    time Frame
    6 months post transplant
  6. description
    Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)
    measure
    Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100
    time Frame
    Day 100 post transplant
  7. description
    Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)
    measure
    Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100
    time Frame
    Day 100 post transplant
  8. description
    Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year. Clinical Limited cGVHD 1. Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD. 2. Mild liver test abnormalities (alkaline phosphatase \<2 x upper limit of normal, AST or ALT \<3 x upper limit of normal and total bilirubin \<1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD. 3. Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving \<20% of body surface area (BSA), dyspigmentation involving \<20% BSA, or erythema involving \<50% BSA, positive skin biopsy, and no other manifestations of cGVHD. 4. Ocular sicca (Schirmer's test \<5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD. 5. Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD.
    measure
    Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year
    time Frame
    1 year post transplant
  9. description
    Number of participants with clinically significant infections at 6 months
    measure
    Incidence of Clinically Significant Infections at 6 Months
    time Frame
    6 months post transplant
  10. description
    Number of participants with clinically significant infections at 1 year
    measure
    Incidence of Clinically Significant Infections at 1 Year
    time Frame
    1 year post transplant
  11. description
    Number of participants with clinically significant infections at 2 years
    measure
    Incidence of Clinically Significant Infections at 2 Years
    time Frame
    2 years post transplant
  12. description
    Kaplan-Meier estimate of the probability of progression-free survival at 1 year
    measure
    Probability of Progression-free Survival at 1 Year
    time Frame
    1 year post transplant
Full study description
brief Summary
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal 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 cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor umbilical cord blood transplant with reduced intensity conditioning works in treating patients with advanced hematological cancer or other disease.
detailed Description
OBJECTIVES: Primary * To estimate the probability of survival at 1 year in patients with advanced hematological malignancies or other diseases treated with non-myeloablative unrelated donor umbilical cord blood transplantation. Secondary * Six month non-relapse mortality. * Chimerism at days 7, 14, 21, 28, 56, and 80, at 6 months, and at 1 and 2 years. * To determine the incidence of neutrophil engraftment at day 42. * To determine the incidence of platelet engraftment at 6 months. * To determine the incidence of grade II-IV and III-IV acute graft-versus-host-disease (GVHD) at day 100. * To determine the incidence of chronic GVHD at 1 year. * To determine the incidence of clinically significant infections at 6 months and at 1 and 2 years. * To determine the probability of progression-free survival at 1 and 2 years. * To determine the probability of survival at 2 years. * To determine the incidence of relapse or disease progression at 1 and 2 years. OUTLINE: Patients are stratified according to disease status and prior therapy (hematologic malignancy or other disease that was treated with an autologous stem cell transplant or ≥ 2 courses of multiagent chemotherapy within the past 3 months vs hematologic malignancy or other disease that was treated with an autologous stem cell transplant \> 12 months ago or with ≤ 1 course of multiagent chemotherapy or immunosuppressive chemotherapy within the past 3 months vs refractory leukemia or lymphoma for which patient was rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy). * Conditioning regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV on day -6. Patients also undergo total body irradiation on day -1. Some patients also receive anti-thymocyte globulin IV on days -6 to -4. * Umbilical cord blood transplantation (UCBT): Patients undergo UCBT on day 0. * Immunosuppressive therapy (graft-versus-host disease prophylaxis): Patients receive cyclosporine IV over 1 hour or orally (as tolerated) every 8 or 12 hours beginning on day -3 and continuing for approximately 6 months. Patients also receive mycophenolate mofetil IV every 8 hours on days -3 to 5 and then orally on days 6-30. After completion of study treatment, patients are followed at 6 months and then annually thereafter.
Source references
Source notices and limitations
    Discovery and provenance
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      source file sha256
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice