Skip to content
Triangle logo TriangleGet started
← Study library

NCT00453206 · REGISTRY CONDITION SEARCH

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases

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

Phase
NA
Status at capture
COMPLETED
Registry last update
2018-09-10

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem 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 tacrolimus, methotrexate, mycophenolate mofetil, and antithymocyte globulin before and after transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer or abnormal cells as not belonging in the patient's body and destroy them (graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with hematologic cancer or other diseases.

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

Treatment-related Mortality Within the First 6 Months After Transplantation

→

outcome · NOT POSTED

Complete Response

→

outcome · NOT POSTED

Overall Survival

→

outcome · NOT POSTED

Disease-free Survival

→

outcome · NOT POSTED

Graft-versus-host Disease

→

outcome · NOT POSTED

Iron Status at the Time of Transplantation

→

outcome · NOT POSTED

Quality of Life at the Time of Transplantation

→

outcome · NOT POSTED

Treatment-related Mortality at 100 Days After Transplantation

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed hematological disease, including any of the following: * Chronic lymphocytic leukemia * Absolute lymphocytosis \> 5,000/µL * Morphologically mature lymphocytes with \< 55% prolymphocytes * Lymphocyte phenotype with expression of CD19 and CD5 * Absence of CD23 expression allowed provided disease is morphologically distinguished from mantle cell lymphoma * Prolymphocytic leukemia * Absolute lymphocytosis \> 5,000/µL * Morphologically mature lymphocytes with \> 55% prolymphocytes * Non-Hodgkin's or Hodgkin's lymphoma * Any WHO classification histologic subtype * Diagnosis by core biopsy allowed provided there is adequate tissue for diagnosis and immunophenotyping * Diagnosis by bone marrow biopsy not acceptable for follicular lymphomas * Multiple myeloma * Has received ≥ 1 prior treatment regimen * Has a partial response or greater by the Blade Criteria * Patients who achieved complete remission are eligible * Acute myeloid leukemia * Documented control (i.e., \< 10% bone marrow blasts and no circulating blasts) * Myelodysplastic syndromes * Documented disease as defined by WHO or French-American-British Cooperative group criteria * Chronic myelogenous leukemia * Patients with atypical chronic myelogenous leukemia (i.e., absent Philadelphia chromosome) are eligible * Polycythemia vera * Documented disease as defined by WHO criteria (i.e., A1 + A2, and any other category A, OR A1 + A2, and any 2 category B): * A1: Total red blood cell mass \> 25% above mean normal predicted value OR hemoglobin \> 18.5 g/dL in males, 16.5 g/dL in females (hematocrit ≥ 60% in males or ≥ 56% in females) * A2: No cause of secondary erythrocytosis (absence of familial erythrocytosis, no elevation of epoetin alfa \[EPO\] due to hypoxia, high oxygen affinity hemoglobin, truncated EPO receptor, or inappropriate ectopic EPO production) * A3: Splenomegaly * A4: Clonal genetic abnormality other than the Philadelphia chromosome * A5: Endogenous erythroid colony formation in vitro * B: Platelet count \> 400,000/mm³, WBC \> 12,000/mm³, bone marrow biopsy with prominent erythroid and megakaryocytic proliferation, and low serum EPO * Chronic idiopathic myelofibrosis * Documented disease as defined by WHO criteria * Must have a HLA-identical donor, a matched unrelated donor, or a HLA 9/10 related donor meeting the following criteria: * HLA-identical sibling (6/6) * Serologic typing for class I (A, B) * Molecular typing for class II (DRB1) * 9/10 matched related donor * High-resolution molecular typing at HLA-A, B, C, DRB1, and DQB1 * Only a single mismatch at one class I or II allele allowed * 10/10 matched unrelated donor * Molecular identity at HLA-A, B, C, DRB1, and DQB1 by high-resolution typing * Syngeneic donors are not eligible * Creatinine clearance ≥ 40 mL/min * Bilirubin ≤ 3 times upper limit of normal (ULN) * AST ≤ 3 times ULN * DLCO ≥ 40% with no symptomatic pulmonary disease * LVEF ≥ 30% by cardiac MRI or echocardiogram with no symptomatic cardiac disease * Fertile patients willing to use effective contraception Exclusion Criteria: * Uncontrolled diabetes mellitus * Active serious infection * Known hypersensitivity to E. coli-derived products * Known HIV positivity * History of another malignancy\*, meeting the following criteria: * Non-skin malignancy or melanoma within the past 5 years * Concomitant malignancy that has not been curatively treated * NOTE: \*However, cancer survivors who have undergone potentially curative therapy for a prior malignancy at least 5 years before enrollment and are deemed at low risk of \< 30% for recurrence by their treating physicians is considered * Pregnant or nursing
healthy Volunteers
false
maximum Age
70 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    allogeneic bone marrow transplantation
    type
    PROCEDURE
  2. name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  3. name
    nonmyeloablative allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  4. name
    peripheral blood stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
66
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Treatment-related Mortality Within the First 6 Months After Transplantation
    time Frame
    6 months
secondary Outcomes
  1. measure
    Complete Response
    time Frame
    monthly
  2. measure
    Overall Survival
    time Frame
    monthly
  3. measure
    Disease-free Survival
    time Frame
    monthly
  4. measure
    Graft-versus-host Disease
    time Frame
    monthly
  5. measure
    Iron Status at the Time of Transplantation
    time Frame
    baseline
  6. measure
    Quality of Life at the Time of Transplantation
    time Frame
    baseline
  7. measure
    Treatment-related Mortality at 100 Days After Transplantation
    time Frame
    100 days
Full study description
brief Summary
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and melphalan, before a donor peripheral stem cell transplant or bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem 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 tacrolimus, methotrexate, mycophenolate mofetil, and antithymocyte globulin before and after transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer or abnormal cells as not belonging in the patient's body and destroy them (graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with hematologic cancer or other diseases.
detailed Description
OBJECTIVES: Primary * Determine the feasibility (i.e., risk of treatment-related mortality during the first 6 months after transplantation) of administering reduced-intensity allogeneic hematopoietic stem cell transplantation to patients with hematologic cancer or other diseases. Secondary * Determine the response rate (partial and complete response), 6- and 12-month probabilities of response, and time to progression in patients treated with this regimen. * Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen. * Determine other toxicities of this regimen in these patients. * Determine the overall survival and disease-free survival of patients treated with this regimen. * Determine the impact of iron status on overall and disease-free survival. * Determine the influence of quality of life (at time of transplantation) on overall survival. OUTLINE: * Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3. Patients also receive busulfan IV over 2 hours every 6 hours on days -4 and -3 or melphalan IV over 2 hours on day -3. * Graft-versus-host disease (GVHD) prophylaxis: Patients with matched related donors receive oral tacrolimus twice daily on days -1 to 90 followed by a taper until day 180. Patients also receive methotrexate IV on days 1, 3, and 6. Patients with matched unrelated and 9/10 matched related donors receive oral tacrolimus twice daily on days -1 to 180 followed by a taper; methotrexate IV on days 1, 3, 6, and 11; and oral mycophenolate mofetil twice daily on days -2 to 60 followed by a taper. All patients also receive antithymocyte globulin IV over 4 to 6 hours once a day on days -4 to -1. * Allogeneic stem cell transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. Patients receive filgrastim (G-CSF) beginning on day 7 and continuing until blood counts recover. * Lymphocyte infusion: Patients with progressive or stable disease while off immunosuppression and no active GVHD may receive up to 3 donor lymphocyte infusions from the original donor at 8-week intervals beginning on day 180 or 210 . Quality of life is assessed at baseline. After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for up to 3 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-25de7a9d62c29c321330
      requested nct id
      NCT00453206
      primary nct id
      NCT00453206
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a4be8fb2a7db9247bdfed231ef84ae19b3babbe8d619ebf7403cceb730eae2d4
      payload sha256
      b23f8d2a0e7048392b591a078fceb31bc437e4b035504b13a54cd4850f6c804c
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-25de7a9d62c29c321330
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00453206
      occurrences
      1. context exact
        NCT00453206
        end
        11
        exact text
        NCT00453206
        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/33/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      66bea6da5a9f0fe12934fbb71eda2782dafc3bf08d688f698174b2d45a711d9c
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a60d4acdc2d294832778
      requested nct id
      NCT00453206
      primary nct id
      NCT00453206
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      payload sha256
      28189fb5687a7f5d754a4162e06be91bec493522e58d5603d8285afa1fa16f98
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a60d4acdc2d294832778
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00453206
      occurrences
      1. context exact
        NCT00453206
        end
        11
        exact text
        NCT00453206
        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/29/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      66bea6da5a9f0fe12934fbb71eda2782dafc3bf08d688f698174b2d45a711d9c
    3. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a66fd036cbbd2cbc39c4
      requested nct id
      NCT00453206
      primary nct id
      NCT00453206
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      payload sha256
      ed1f8c1b5e3887fa43615e0b2d7201d437703bb81bd2a444bf6a3e108fdc9a26
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a66fd036cbbd2cbc39c4
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00453206
      occurrences
      1. context exact
        NCT00453206
        end
        11
        exact text
        NCT00453206
        start
        0
      offset unit
      unicode_code_points
      query cond
      Acute Undifferentiated Leukemia
      query disease state id
      ds-acute-undifferentiated-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-acute-undifferentiated-leukemia-000.json
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      source json pointer
      /studies/26/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      66bea6da5a9f0fe12934fbb71eda2782dafc3bf08d688f698174b2d45a711d9c
    4. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-ccdfbb3d16a64ab1087c
      requested nct id
      NCT00453206
      primary nct id
      NCT00453206
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      f4963e58ef8b425167df3f5d70396894ba2a3f70087db227a778eb7eec44de61
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-ccdfbb3d16a64ab1087c
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00453206
      occurrences
      1. context exact
        NCT00453206
        end
        11
        exact text
        NCT00453206
        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/551/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      66bea6da5a9f0fe12934fbb71eda2782dafc3bf08d688f698174b2d45a711d9c

    Preserved source evidence · Not medical advice