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NCT00119366 · REGISTRY CONDITION SEARCH

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

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
2022-12-12

This phase II trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate, total-body irradiation, and donor stem cell transplant followed by cyclosporine and mycophenolate mofetil in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other places in the body and usually cannot be cured or controlled with treatment. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal 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 fludarabine phosphate and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together with donor stem cell transplant, cyclosporine, and mycophenolate mofetil may be an effective treatment for advanced acute myeloid leukemia or myelodysplastic syndromes.

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

Number of Participants With Dose-limiting Toxicities (DLT) 100 Days After Transplant

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outcome · POSTED

Number of Participants With Transplant Related Mortality Within 100 Days After Transplant

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outcome · POSTED

Participant Disease Response Within 4 Weeks After Transplant

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outcome · POSTED

Severity of Acute GVHD in Patients Who Completed the Study Treatment

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outcome · POSTED

Number of Participants With 100% Donor Chimerism at Day 28 and Day 84

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outcome · POSTED

Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen

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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
Inclusion Criteria: * Patients with advanced AML defined as beyond first remission, primary refractory disease, or evolved from myelodysplastic or myeloproliferative syndromes; or patients with MDS expressed as refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEBT), refractory cytopenia with multilineage dysplasia (RCMD), RCMD with ringed sideroblasts (RCMD-RS), or chronic myelomonocytic leukemia (CMML) * Patients not in remission must have CD45-expressing leukemic blasts or myelodysplastic cells; patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \>= 95% of nucleated cells in the marrow) * Patients should have a circulating blast count of less than 10,000/mm\^3 (control with hydroxyurea or similar agent is allowed) * Patients must have an estimated creatinine clearance greater than 50/ml per minute (serum creatinine value must be within 28 days prior to registration) * Bilirubin \< 2 times the upper limit of normal * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2 times the upper limit of normal * Karnofsky score \>= 70 or Eastern Cooperative Oncology Group (ECOG) =\< 2 * Patients must have an expected survival of \> 60 days and must be free of active infection * Patients must have an HLA-identical sibling donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) donation; related donors should be matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and developmentally regulated RNA binding protein 1 (DRB1) according to Fred Hutchinson Cancer Research Center (FHCRC) Standard Practice Guidelines and to the allele level at DQB1; unrelated donors should be identified using matching criteria that follows the FHCRC Standard Practice Guidelines limiting the study to eligible donors that are allele matched for HLA-A, B, C, DRB1, and DQB1 (grade 1), and accepting up to one allele mismatch as per Standard Practice grade 2.1 for HLA-A, B, or C * DONOR: Donors must meet HLA matching criteria as well as standard SCCA and/or NMDP or other donor center criteria for PBSC donation Exclusion Criteria: * Circulating antibody against mouse immunoglobulin (human anti-mouse antibody \[HAMA\]) * Prior radiation to maximally tolerated levels to any normal organ * Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects * Inability to understand or give an informed consent * Patients who are seropositive for human immunodeficiency virus (HIV) * Perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation * Patients who have previously undergone autologous or allogeneic HSCT
healthy Volunteers
false
maximum Age
50 Years
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.
    intervention Names
    1. Radiation: iodine I 131 monoclonal antibody BC8
    2. Drug: fludarabine phosphate
    3. Radiation: total-body irradiation
    4. Procedure: allogeneic hematopoietic stem cell transplantation
    5. Procedure: peripheral blood stem cell transplantation
    6. Drug: cyclosporine
    7. Drug: mycophenolate mofetil
    8. Other: laboratory biomarker analysis
    label
    Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8
    type
    EXPERIMENTAL
  2. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.
    intervention Names
    1. Radiation: iodine I 131 monoclonal antibody BC8
    2. Drug: fludarabine phosphate
    3. Radiation: total-body irradiation
    4. Procedure: allogeneic hematopoietic stem cell transplantation
    5. Procedure: peripheral blood stem cell transplantation
    6. Drug: cyclosporine
    7. Drug: mycophenolate mofetil
    8. Other: laboratory biomarker analysis
    label
    Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8
    type
    EXPERIMENTAL
  3. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.
    intervention Names
    1. Radiation: iodine I 131 monoclonal antibody BC8
    2. Drug: fludarabine phosphate
    3. Radiation: total-body irradiation
    4. Procedure: allogeneic hematopoietic stem cell transplantation
    5. Procedure: peripheral blood stem cell transplantation
    6. Drug: cyclosporine
    7. Drug: mycophenolate mofetil
    8. Other: laboratory biomarker analysis
    label
    Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8
    type
    EXPERIMENTAL
  4. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.
    intervention Names
    1. Radiation: iodine I 131 monoclonal antibody BC8
    2. Drug: fludarabine phosphate
    3. Radiation: total-body irradiation
    4. Procedure: allogeneic hematopoietic stem cell transplantation
    5. Procedure: peripheral blood stem cell transplantation
    6. Drug: cyclosporine
    7. Drug: mycophenolate mofetil
    8. Other: laboratory biomarker analysis
    label
    Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8
    type
    EXPERIMENTAL
  5. description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.
    intervention Names
    1. Radiation: iodine I 131 monoclonal antibody BC8
    2. Drug: fludarabine phosphate
    3. Radiation: total-body irradiation
    4. Procedure: allogeneic hematopoietic stem cell transplantation
    5. Procedure: peripheral blood stem cell transplantation
    6. Drug: cyclosporine
    7. Drug: mycophenolate mofetil
    8. Other: laboratory biomarker analysis
    label
    Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8
    2. Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8
    3. Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8
    4. Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8
    5. Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8
    description
    Given IV
    name
    iodine I 131 monoclonal antibody BC8
    other Names
    1. I 131 MOAB BC8
    2. I 131 Monoclonal Antibody BC8
    3. iodine I 131 MOAB BC8
    type
    RADIATION
  2. arm Group Labels
    1. Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8
    2. Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8
    3. Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8
    4. Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8
    5. Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8
    description
    Given IV
    name
    fludarabine phosphate
    other Names
    1. 2-F-ara-AMP
    2. Beneflur
    3. Fludara
    type
    DRUG
  3. arm Group Labels
    1. Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8
    2. Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8
    3. Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8
    4. Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8
    5. Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8
    description
    Undergo TBI
    name
    total-body irradiation
    other Names
    1. TBI
    type
    RADIATION
  4. arm Group Labels
    1. Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8
    2. Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8
    3. Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8
    4. Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8
    5. Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8
    description
    Undergo PBSC transplantation
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  5. arm Group Labels
    1. Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8
    2. Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8
    3. Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8
    4. Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8
    5. Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8
    description
    Undergo PBSC transplantation
    name
    peripheral blood stem cell transplantation
    other Names
    1. PBPC transplantation
    2. PBSC transplantation
    3. peripheral blood progenitor cell transplantation
    4. transplantation, peripheral blood stem cell
    type
    PROCEDURE
  6. arm Group Labels
    1. Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8
    2. Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8
    3. Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8
    4. Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8
    5. Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8
    description
    Given IV or PO
    name
    cyclosporine
    other Names
    1. ciclosporin
    2. cyclosporin
    3. cyclosporin A
    4. CYSP
    5. Sandimmune
    type
    DRUG
  7. arm Group Labels
    1. Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8
    2. Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8
    3. Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8
    4. Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8
    5. Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8
    description
    Given PO
    name
    mycophenolate mofetil
    other Names
    1. Cellcept
    2. MMF
    type
    DRUG
  8. arm Group Labels
    1. Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8
    2. Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8
    3. Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8
    4. Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8
    5. Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
intervention Model Description
This study will assess the feasibility and safety of patients with advanced AML or high-risk MDS treated with Iodine-131 BC8 antibody at a starting dose of 22 Gy delivered to the normal organ receiving the highest dose combined with fludarabine and 2 Gy total body irradiation (TBI), plus cyclosporine (CSP)/mycophenolate mofetil (MMF), followed by matched related or unrelated allogeneic hematopoietic stem cell transplantation (HSCT). Determination of the maximum tolerated dose (MTD) will be the major study endpoint. Dose-escalation/de-escalation of radiolabeled BC8 antibody (I-131-BC8) is conducted using a "two-stage" approach. Under this plan, dose levels during the first stage are increased (or decreased) for individual patients until a dose-limiting toxicity (DLT) is observed, at which point the second stage proceeds with each dose level administered to a cohort of four patients.
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
18
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows: Grade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible. Grade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, the toxicity obtained would be manageable by clinical methods but may interfere with other therapies. Grade 3 Development of major clinical, chemical or laboratory abnormalities which represent maximum toxicities without being fatal. This grade of toxicity is designed to be the dose-limiting toxicity.
    measure
    Number of Participants With Dose-limiting Toxicities (DLT) 100 Days After Transplant
    time Frame
    Up to 100 days post-transplant
secondary Outcomes
  1. description
    Number of participants that received and completed study treatment who died within 100 days after transplant
    measure
    Number of Participants With Transplant Related Mortality Within 100 Days After Transplant
    time Frame
    Up to 100 days post-transplant
  2. description
    The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant. Complete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following: * Normal bone marrow with blasts \<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis. * Normalization of blood counts (no blasts, platelets \>100,000/mm3, granulocytes \>1,500/mm3). * No extramedullary disease. Relapse is measured as follows: * After CR: \>5% blasts in the bone marrow and/or peripheral blood. * Confirmation of relapse by bone marrow analysis with more than 10% blasts. * Extramedullary disease confirmed cytologically or histologically.
    measure
    Participant Disease Response Within 4 Weeks After Transplant
    time Frame
    4 weeks after transplant
  3. description
    The severity of acute GVHD is measured based on Graft-vs-Host Disease: Severity of GVHD Grade I +1 to +2 skin rash No gut or liver involvement Grade II +3 skin rash or * 1 gastrointestinal involvement and/or +1 liver involvement Grade III +2 to +4 gastrointestinal involvement and/or * 2 to +4 liver involvement with or without a rash Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
    measure
    Severity of Acute GVHD in Patients Who Completed the Study Treatment
    time Frame
    100 days after transplant
  4. description
    Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis
    measure
    Number of Participants With 100% Donor Chimerism at Day 28 and Day 84
    time Frame
    Day 28 and Day 80 after transplant
  5. description
    Survival and complete resolution of all signs of leukemia for 2 years after transplant with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis. 2. Normalization of blood counts (no blasts, platelets \>100,000/mm3, granulocytes \>1,500/mm3). 3. No extramedullary disease.
    measure
    Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen
    time Frame
    2 years post transplant
Full study description
brief Summary
This phase II trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate, total-body irradiation, and donor stem cell transplant followed by cyclosporine and mycophenolate mofetil in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has spread to other places in the body and usually cannot be cured or controlled with treatment. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal 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 fludarabine phosphate and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together with donor stem cell transplant, cyclosporine, and mycophenolate mofetil may be an effective treatment for advanced acute myeloid leukemia or myelodysplastic syndromes.
detailed Description
PRIMARY OBJECTIVES: I. To evaluate the maximum tolerated dose (MTD) and the transplant-related mortality (TRM) and toxicity of delivering 131I-BC8 (iodine I 131 monoclonal antibody BC8) (anti-cluster of differentiation \[CD\]45 antibody) at a starting dose of 22 Gy to the normal organ receiving the highest dose in combination with the non-myeloablative regimen of fludarabine (fludarabine phosphate) (FLU), 2 Gy total body irradiation (TBI), cyclosporine (CSP), mycophenolate mofetil (MMF), and human leukocyte antigen (HLA)-matched related or unrelated allogeneic hematopoietic stem cell transplant (HSCT) in patients 16 to 50 years old who have advanced acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS). II. To estimate rates of donor chimerism resulting from this combined preparative regimen and to correlate level of donor chimerism with estimated radiation doses delivered to hematopoietic tissues via antibody. III. To determine rates of disease relapse, graft vs. host disease, and 2-year disease-free survival in patients receiving 131I-BC8 antibody combined with FLU, 2 Gy TBI, CSP, MMF, and HLA-matched related or unrelated allogeneic HSCT. OUTLINE: This is a dose-escalation study of iodine I 131 monoclonal antibody BC8. RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 intravenously (IV) on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic peripheral blood stem cell (PBSC) transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or orally (PO) twice daily (BID) on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO thrice daily (TID) on days 0 to 40 followed by a taper to day 96. After completion of study treatment, patients are followed up at 6, 9, 12, 18, and 24 months and then annually thereafter.
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      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00119366
      occurrences
      1. context exact
        NCT00119366
        end
        11
        exact text
        NCT00119366
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Chronic Myeloid Leukemia
      query disease state id
      ds-chronic-myeloid-leukemia-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-chronic-myeloid-leukemia-000.json
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      source json pointer
      /studies/42/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      f352365b6fe8077897cf44cb677128a55d353cd3e05c651d030cf444d088fe66

    Preserved source evidence · Not medical advice