Skip to content
Triangle logo TriangleGet started
← Study library

NCT00003270 · REGISTRY CONDITION SEARCH

Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer

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
COMPLETED
Registry last update
2019-12-13

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and umbilical cord blood transplantation in treating patients with hematologic cancer.

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

→

baseline

Baseline characteristics

→

outcome · POSTED

Overall Response Rate

→

outcome · POSTED

Progression-free Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy Acute lymphocytic leukemia (ALL): In second or later remission In first remission with poor prognostic features (Philadelphia chromosome positive) Acute myeloid leukemia (AML): In second or later remission In first remission with poor prognostic features, e.g., Arising from myelodysplastic syndrome Cytogenetics with -5, -7, +8, 11q23 abnormalities Complex cytogenetics AML or ALL refractory to induction or in relapse Myelodysplastic syndrome Chronic myelogenous leukemia Severe aplastic anemia or Fanconi's anemia Relapsed Hodgkin's disease Relapsed non-Hodgkin's lymphoma Multiple myeloma No suitable family donor matched for 5 or 6 HLA antigens (A, B, DR) No suitable unrelated donor matched for 6 HLA antigens Cord blood donor available matched for 4-6 out of 6 HLA antigens PATIENT CHARACTERISTICS: Age: 5 to 50 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 times normal Alkaline phosphatase less than 3 times normal SGOT less than 3 times normal Renal: Creatinine less than 2 times normal OR Creatinine clearance greater than 60 mL/min Cardiovascular: MUGA with ejection fraction at least 50% Pulmonary: DLCO and spirometry at least 60% OR Exercise VO2 max/kg at least 15 mL/min/kg Other: HIV antibody negative Hepatitis B surface antigen negative No active bacterial, viral, or fungal infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed If following limits have not been exceeded, patient may receive total body irradiation: No prior radiation to one entire kidney Whole liver received no greater than 1000 cGy No prior whole abdomen radiotherapy Small bowel received no greater than 3000 cGy Heart received no greater than 1800 cGy No prior whole lung radiotherapy CNS received less than 30 cGy (whole brain or any portion of the spine) Surgery: Not specified
healthy Volunteers
false
maximum Age
50 Years
minimum Age
5 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients eligible to undergo total body irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1. Cord blood is infused on day 0
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Biological: filgrastim
    3. Drug: busulfan
    4. Drug: cyclophosphamide
    5. Drug: cyclosporine
    6. Drug: methylprednisolone
    7. Procedure: bone marrow ablation with stem cell support
    8. Procedure: umbilical cord blood transplantation
    9. Radiation: radiation therapy
    label
    Arm 1
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm 1
    description
    IV
    name
    anti-thymocyte globulin
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm 1
    description
    IV
    name
    filgrastim
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Arm 1
    description
    IV
    name
    busulfan
    type
    DRUG
  4. arm Group Labels
    1. Arm 1
    description
    IV
    name
    cyclophosphamide
    type
    DRUG
  5. arm Group Labels
    1. Arm 1
    description
    IV
    name
    cyclosporine
    type
    DRUG
  6. arm Group Labels
    1. Arm 1
    description
    IV
    name
    methylprednisolone
    type
    DRUG
  7. arm Group Labels
    1. Arm 1
    description
    IV
    name
    bone marrow ablation with stem cell support
    type
    PROCEDURE
  8. arm Group Labels
    1. Arm 1
    description
    IV
    name
    umbilical cord blood transplantation
    type
    PROCEDURE
  9. arm Group Labels
    1. Arm 1
    description
    High energy X-rays
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Continuous complete remission (for patients in complete remission before treatment) or induced complete remission (for patients not in complete remission before treatment)
    measure
    Overall Response Rate
    time Frame
    day +100 after Cord Blood Transplant
secondary Outcomes
  1. description
    time to disease progression or death due to any cause
    measure
    Progression-free Survival
    time Frame
    1 year
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and umbilical cord blood transplantation in treating patients with hematologic cancer.
detailed Description
OBJECTIVES: I. Determine the safety, efficacy, and toxicity of using cord blood as a source for stem cell transplantation in patients with hematologic malignancies. OUTLINE: Patients undergo autologous bone marrow harvesting or peripheral stem cell collection prior to transplant regimen, unless the patient has acute leukemia in relapse, aplastic anemia, or myelodysplastic syndrome. Arm I: Patients eligible to undergo total body irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1. Cord blood is infused on day 0. Arm II: Patients not eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses. Cyclophosphamide, ATG, and cord blood are then administered as in arm I. All patients receive cyclosporine on days -2 to 180, methylprednisolone on days 5-180, and filgrastim (G-CSF) from day 1. Patients are followed weekly until day 180 and then monthly for 2 years. PROJECTED ACCRUAL: A total of 20 patients (10 patients per arm) will be accrued for this study within 4 years.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-81018922db7f3ad44c73
      requested nct id
      NCT00003270
      primary nct id
      NCT00003270
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
      payload sha256
      b2ac25743ca48b9f9609aecd321c27d425508c79cdd0b614f805de3c1a596c07
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-81018922db7f3ad44c73
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00003270
      occurrences
      1. context exact
        NCT00003270
        end
        11
        exact text
        NCT00003270
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Myelodysplastic Neoplasms
      query disease state id
      ds-myelodysplastic-neoplasms-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-myelodysplastic-neoplasms-000.json
      source file sha256
      a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
      source json pointer
      /studies/63/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      86dedaca27ed069844e0c9c08976d1b67c397b76e1f73f8afbc561bc94778969
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-c78a2a3139066e8a92dd
      requested nct id
      NCT00003270
      primary nct id
      NCT00003270
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      22ed6d98901acb268388c5a86b4ac4c84b522162f6e0e108bc41b0b64d0277de
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-c78a2a3139066e8a92dd
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00003270
      occurrences
      1. context exact
        NCT00003270
        end
        11
        exact text
        NCT00003270
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/991/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      86dedaca27ed069844e0c9c08976d1b67c397b76e1f73f8afbc561bc94778969
    3. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-ec43693cd0c89ca2fde4
      requested nct id
      NCT00003270
      primary nct id
      NCT00003270
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      payload sha256
      9352a719dea2f8679a866a6925d177ed7a3995dad0ffefe6d1ae243457346c3b
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-ec43693cd0c89ca2fde4
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00003270
      occurrences
      1. context exact
        NCT00003270
        end
        11
        exact text
        NCT00003270
        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/57/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      86dedaca27ed069844e0c9c08976d1b67c397b76e1f73f8afbc561bc94778969

    Preserved source evidence · Not medical advice