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NCT01044745 · REGISTRY CONDITION SEARCH

Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for 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
TERMINATED
Registry last update
2023-09-06

This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer 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 a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening

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 Grades II-IV Acute GVHD

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outcome · POSTED

Event-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Transplant-related Mortality (TRM)

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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: * Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML) in accelerated phase or blast crisis, chronic lymphocytic leukemia (CLL), Non-Hodgkin lymphoma (NHL), myelodysplastic syndromes (MDS) (intermediate-2 or high-risk disease by International Pelvic Pain Society \[IPPS\]) * Patients with AML, ALL, or MDS scheduled for myeloablative conditioning should have =\< 10% blasts in bone marrow or peripheral blood at the start of conditioning * Patients with AML, ALL, or CML scheduled for reduced intensity conditioning or non-myeloablative conditioning should be in complete morphologic remission at the start of conditioning (residual disease by flow cytometry or cytogenetics and/or incomplete recovery of neutrophil or platelet count are acceptable) * Patients with CLL or NHL scheduled for reduced intensity or non-myeloablative conditioning should have no evidence of bulky disease (\> 50% bone marrow involvement or masses \> 10 cm) at the start of conditioning * Fulfills all pulmonary, cardiac, renal, and hepatic criteria for standard-of-care matched unrelated donor (MUD) allogeneic HCT * Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after stem cell transplantation * Adequately matched unrelated donor available * Written informed consent; written informed consent of the unrelated donor is required to participate in the optional studies Exclusion Criteria: * Patient or donor infected with human immunodeficiency virus (HIV) * Patient or donor with history of hepatitis B or C and/or positive serology consistent with previous hepatitis B or C infection (patients and/or donor who received Hepatitis B vaccination are acceptable) * Patient or donor with active hepatitis B or C and/or detectable viral ribonucleic acid (RNA) * More than 20,000 circulating CD20+ cells/uL * Treatment with rituximab for any reason in the 12 months preceding HCT * Patient scheduled for cord blood transplantation * Presence of active uncontrolled infection at start of conditioning * Presence of active central nervous system (CNS) disease (history of adequately treated CNS disease is acceptable) * Presence of uncontrolled psychiatric disorder * Patient unable to give informed consent * Unrelated donor products received from the Deutsche Knochenmarkspenderdatei (DKMS) Registry are not eligible for the optional study
healthy Volunteers
false
maximum Age
75 Years
minimum Age
19 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
    intervention Names
    1. Drug: rituximab
    2. Drug: mycophenolate mofetil
    3. Drug: tacrolimus
    4. Drug: anti-thymocyte globulin
    5. Procedure: allogeneic hematopoietic stem cell transplantation
    6. Other: laboratory biomarker analysis
    7. Biological: graft versus host disease prophylaxis/therapy
    8. Drug: cyclophosphamide
    9. Drug: fludarabine phosphate
    10. Drug: busulfan
    11. Radiation: total-body irradiation
    12. Biological: graft-versus-tumor induction therapy
    label
    Treatment (Rituximab and allogeneic HCT transplant)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Given IV
    name
    rituximab
    other Names
    1. IDEC-C2B8
    2. IDEC-C2B8 monoclonal antibody
    3. Mabthera
    4. MOAB IDEC-C2B8
    5. Rituxan
    type
    DRUG
  2. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Given IV or PO
    name
    mycophenolate mofetil
    other Names
    1. Cellcept
    2. MMF
    type
    DRUG
  3. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Given IV
    name
    tacrolimus
    other Names
    1. FK 506
    2. Prograf
    type
    DRUG
  4. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Given IV
    name
    anti-thymocyte globulin
    other Names
    1. ATG
    2. ATGAM
    3. lymphocyte immune globulin
    4. Thymoglobulin
    type
    DRUG
  5. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Stem cell transplant
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  6. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
  7. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Undergo graft versus host disease prophylaxis/therapy
    name
    graft versus host disease prophylaxis/therapy
    other Names
    1. prophylaxis/therapy, graft versus host disease
    2. prophylaxis/therapy, GVHD
    type
    BIOLOGICAL
  8. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Given PO or IV
    name
    cyclophosphamide
    other Names
    1. CPM
    2. CTX
    3. Cytoxan
    4. Endoxan
    5. Endoxana
    type
    DRUG
  9. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Given IV
    name
    fludarabine phosphate
    other Names
    1. 2-F-ara-AMP
    2. Beneflur
    3. Fludara
    type
    DRUG
  10. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Given IV
    name
    busulfan
    other Names
    1. BSF
    2. BU
    3. Misulfan
    4. Mitosan
    5. Myeloleukon
    type
    DRUG
  11. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Undergo TBI
    name
    total-body irradiation
    other Names
    1. TBI
    type
    RADIATION
  12. arm Group Labels
    1. Treatment (Rituximab and allogeneic HCT transplant)
    description
    Undergo graft-versus-tumor induction therapy
    name
    graft-versus-tumor induction therapy
    other Names
    1. graft versus host disease induction
    2. graft versus tumor induction
    type
    BIOLOGICAL
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
    Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
    measure
    Number of Participants With Grades II-IV Acute GVHD
    time Frame
    At day 100
secondary Outcomes
  1. description
    Estimated using Kaplan-Meier estimator.
    measure
    Event-free Survival
    time Frame
    From the date of transplant with relapse/progression or death as censored events, up to 2 years
  2. description
    Estimated using Kaplan-Meier estimator.
    measure
    Overall Survival
    time Frame
    From the date of transplant with death from any cause as a censored event, up to 2 years
  3. description
    Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.
    measure
    Transplant-related Mortality (TRM)
    time Frame
    At day 100
Full study description
brief Summary
This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer 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 a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening
detailed Description
PRIMARY OBJECTIVES: I. To determine the incidence of grade II-IV acute GVHD at day 100 after matched unrelated donor allogeneic hematopoietic cell transplantation (HCT) when incorporating rituximab in the conditioning regimen. SECONDARY OBJECTIVES: I. To determine the day 100 transplant related mortality after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen. II. To determine overall survival (OS) and disease-free survival (DFS) after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen. III. To determine the cumulative incidence of infectious complications at day 100 after matched unrelated donor HCT when incorporating rituximab in the conditioning regimen. IV. To determine the effect of rituximab addition to the conditioning regimen on recovery of T regulatory (T-reg) cells, and to determine the effect of T-cell, including T-reg, number in the stem cell product and at day 30 on the incidence of grade II-IV acute GVHD (aGVHD) and the cumulative infectious complications at day 100. V. To determine the effect of rituximab addition to the conditioning regimen on antigen presenting myeloid cell recovery, and to determine the effect of dendritic cell subset DC1, DC2 and myeloid-derived suppressor cells (MDSC), number in the stem cell graft and at day +30 on the incidence of acute GVHD grade II-IV and the cumulative incidence of infectious complications at day 100. OUTLINE: CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and total-body irradiation (TBI); targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab intravenously (IV) on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then orally (PO) beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients are followed up periodically for 100 days after transplant.
Source references
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice