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NCT00617929 · REGISTRY CONDITION SEARCH

Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant

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
2017-12-28

RATIONALE: Antithymocyte globulin, clofarabine, and rituximab may stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. 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 antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with clofarabine and rituximab works in treating patients after an unsuccessful stem cell transplant.

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

Rate of Sustained Donor Engraftment

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outcome · POSTED

Survival at 100 Days Post Transplant

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outcome · POSTED

Treatment-related Death

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outcome · POSTED

Time to Primary Neutrophil Engraftment

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outcome · POSTED

Survival

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outcome · POSTED

Chimerism

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outcome · POSTED

Acute Graft-vs-host Disease

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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
Patient Inclusion Criteria: * Timing of relevant evaluations: Taking in account the need for rapid intervention, if white blood count is less than 200 on day +20, bone marrow aspirate should be performed on day +21. Unless there is an increase in absolute neutrophil count (ANC) to \> 500 in the following 7 days, bone marrow aspirate should be repeated on day +28. If the white blood count is still less than 200 and bone marrow is acellular, bone marrow (BM) or peripheral blood stem cell (PBSC) donor should be reactivated and availability of cord blood (CB) units assessed. If the BM or PBSC donor is not confirmed within 14 days of the request for the donation (typically second donation from the same donor), CB unit should be used instead. Primary or secondary graft failure after hematopoietic stem cell transplantation defined as a \> 50% loss of donor chimerism from previous maximum or less than 25% donor beyond day +42 with pancytopenia and no evidence of relapse. Patients with any diagnosis, type of donor, hematopoietic cell graft or conditioning regimen should be considered for this study. * primary graft failure is defined as: * ANC \< 500 * BM \< 10% on two occasions (Day +21 and Day +28) * Donor chimerism need not to be considered, provided there is no evidence of malignancy * secondary graft failure is defined as \< 5% cellularity and ANC \< 500 for more than 7 days any time after primary engraftment). * Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. * Patients or their guardian are able and willing to provide written informed consent. Patient Exclusion Criteria: The presence of any of the following excludes a patient from study enrollment: * Uncontrolled active infection defined as more than one week with no response to appropriately chosen antibiotics * Evidence of recurrence of primary malignancy. * Pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. Women of childbearing age must use appropriate methods as described. * Allergy to rituximab. * Evidence of HIV infection or positive HIV serology. * Autologous recovery defined as defined as greater than 90% recipient PCR product in the competitive VNTR PCR performed on gradually increasing white blood cell count. Donor Inclusion Criteria: * Related donors must be 2-75 years of age and in good health. * Meets match criteria * Able and willing to undergo cell collection procedures (bone marrow cell collection or leukapheresis) * Not pregnant or lactating. * HIV-1, HIV-2 negative; HTLV-1, HTLV-2 negative, Hepatitis B and C negative. * Patients or their guardian are able and willing to provide informed consent
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Primary or secondary graft failure after hematopoietic stem cell transplantation defined as a \> 50% loss of previously best donor chimerism or less than 25% donor chimerism beyond day +42 with pancytopenia and no evidence of relapse. Patients with any diagnosis, type of donor, hematopoietic cell graft or conditioning regimen should be considered for this study. Patients receive anti-thymocyte globulin, rituximab, and clofarabine.
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Biological: rituximab
    3. Drug: clofarabine
    4. Procedure: stem cell transplantation
    label
    Conditioning for Graft Failure
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Conditioning for Graft Failure
    description
    administer 3 mg/kg intravenously (IV) over 4 hours on days -6, -5 and -4.
    name
    anti-thymocyte globulin
    other Names
    1. Thymoglobulin®
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Conditioning for Graft Failure
    description
    administered 375 mg/m\^2 intravenously (IV) in 1 mg/mL normal saline on day -7.
    name
    rituximab
    other Names
    1. Rituxan(R)
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Conditioning for Graft Failure
    description
    administered 30 mg/m\^2 intravenously (IV) over 1 hour on Days -4, -3, and -2.
    name
    clofarabine
    other Names
    1. CLOLAR™
    type
    DRUG
  4. arm Group Labels
    1. Conditioning for Graft Failure
    description
    administered on Day 0 per institutional guidelines.
    name
    stem cell transplantation
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
12
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Rate of Sustained Donor Engraftment is defined as the percent of paticipants with an absolute neutrophile count (ANC) of 500 or more without a subsequent graft rejection.
    measure
    Rate of Sustained Donor Engraftment
    time Frame
    Day 42 post transplantation
  2. description
    Percent of patients alive from beginning of study to Day 100 post transplantation
    measure
    Survival at 100 Days Post Transplant
    time Frame
    Day 100 post transplantation
secondary Outcomes
  1. description
    Percent of patients who died related to the treatment in this study.
    measure
    Treatment-related Death
    time Frame
    Day 100 post transplantation
  2. description
    Time to primary neutrophil engraftment is defined as the percent of patients with an absolute neutrophil count (ANC) of 500 or more neutrophils in a cubic millimeter of blood.
    measure
    Time to Primary Neutrophil Engraftment
    time Frame
    Day 42 post transplantation
  3. description
    Percent of patients alive from beginning of study to one year post transplantation
    measure
    Survival
    time Frame
    One year post transplantation
  4. description
    Occurrence of genetically distinct cell types in a single organism
    measure
    Chimerism
    time Frame
    Day 28 post transplantation
  5. description
    Percent of patients with Acute Graft-vs-host Disease - a process where T-cells present in the donor's bone marrow at the time of transplant identify the transplant patient as "non-self' and attack the patient's skin, liver, stomach, and/or intestines.
    measure
    Acute Graft-vs-host Disease
    time Frame
    Day 30-100
Full study description
brief Summary
RATIONALE: Antithymocyte globulin, clofarabine, and rituximab may stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. 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 antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with clofarabine and rituximab works in treating patients after an unsuccessful stem cell transplant.
detailed Description
OBJECTIVES: Primary * To determine the rate of sustained donor engraftment at 42 days and survival at 100 days post transplantation in patients treated with anti-thymocyte globulin, clofarabine, and rituximab. Secondary * To determine incidence of treatment-related mortality at day 100 post transplantation. * To determine incidence of neutrophil recovery by day 42 post transplantation. * To determine survival at day 100 and 1 year post transplantation. * To determine the proportion of patients with chimerism at day 28 post transplantation. * To determine incidence and severity of grades II-IV acute graft-vs-host disease by day 100 post transplantation. OUTLINE: * Conditioning regimen: Patients receive rituximab intravenously (IV) on day -7, anti-thymocyte globulin IV over 4-6 hours on days -6 to -4, and clofarabine IV over 1 hour on days -4 to -2. * Hematopoietic stem cell transplantation (HSCT): Patients undergo HSCT on day 0. Patients may receive umbilical cord blood, peripheral blood stem cells, or bone marrow from unrelated or related donors. * Graft-vs-host disease (GVHD) prophylaxis: Patients receive oral cyclosporine twice daily or cyclosporine IV every 8 hours beginning on day -3 and continuing for 100 or 180 days post transplantation followed by a taper; mycophenolate mofetil IV every 8 hours beginning on day -3 and continuing for 30 days (or 7 days after engraftment with no evidence of GVHD); and filgrastim (G-CSF) IV once daily beginning on day 1 and continuing until blood counts recover. After completion of study therapy, patients are followed on days 100, 180, and 360.
Source references
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      NCT00617929
      occurrences
      1. context exact
        NCT00617929
        end
        11
        exact text
        NCT00617929
        start
        0
      offset unit
      unicode_code_points
      query cond
      Testicular Cancer
      query disease state id
      ds-testicular-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      source json pointer
      /studies/20/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      a74971a2ade7270f5655daa969742be67f250e38f5d974e068ff01a6be0be8b2
    10. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-faec2e981e03bbfe32f2
      requested nct id
      NCT00617929
      primary nct id
      NCT00617929
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      193739e64f77123de4344901c9970a0996a667fa587f14135380bef3ae38e11d
      payload sha256
      b0a6376e5dfd16bb9728914a3e21db7a46890ee3ae1795f44ef3b035f30d89f3
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-faec2e981e03bbfe32f2
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00617929
      occurrences
      1. context exact
        NCT00617929
        end
        11
        exact text
        NCT00617929
        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/26/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      a74971a2ade7270f5655daa969742be67f250e38f5d974e068ff01a6be0be8b2

    Preserved source evidence · Not medical advice