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NCT00105001 · REGISTRY CONDITION SEARCH

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing 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
COMPLETED
Registry last update
2019-10-30

This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body-irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system 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 MMF and tacrolimus with or without sirolimus after 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

Number of Non-Relapse Mortalities

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outcome · POSTED

Number of Participants Utilizing High-Dose Corticosteroids

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outcome · POSTED

Number of Participants Surviving Overall

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outcome · POSTED

Number of Participants Surviving Without Progression

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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: * Ages \> 50 years with hematologic malignancies treatable by unrelated hematopoietic cell transplant (HCT) * Ages =\< 50 years of age with hematologic diseases treatable by allogeneic HCT who through pre-existing medical conditions or prior therapy are considered to be at high risk for regimen related toxicity associated with a conventional transplant (\> 40% risk of transplant related mortality \[TRM\]) (This criterion can include patients with a HCT-comorbidity index (CI) score of \>= 1; transplants should be approved for these inclusion criteria by both the participating institutions' patient review committees such as the Patient Care Conference (PCC) at the Fred Hutchinson Cancer Research Center (FHCRC) and by the principal investigators at the collaborating centers) * Patients =\< 50 years of age who have received previous high-dose transplantation do not require patient review committee approvals (All children \< 12 years must be discussed with the FHCRC principal investigator (PI) \[Brenda Sandmaier, MD 206 6674961\] prior to registration) * Ages =\< 50 years of age with chronic lymphocytic leukemia (CLL); these patients do not require patient review committee approvals * Ages =\< 50 years of age with hematologic diseases treatable by allogeneic HCT who refuse a conventional HCT (Transplants must be approved for these inclusion criteria by both the participating institutions' patient review committee such as PCC at the FHCRC and by the principal investigators at the collaborating centers) * The following diseases will be permitted although other diagnoses can be considered if approved by PCC or the participating institutions' patient review committees and the principal investigators: * Aggressive non-Hodgkin lymphomas (NHL) and other histologies such as Diffuse large B cell NHL not eligible for autologous hematopoietic stem cell transplant (HSCT), not eligible for conventional myeloablative HSCT, or after failed autologous HSCT * Mantle Cell NHL may be treated in first complete response (CR) (Diagnostic lumbar puncture \[LP\] required pretransplant) * Low grade NHL with \< 6 month duration of CR between courses of conventional therapy * CLL must have either * Failed to meet National Cancer Institute (NCI) Working Group criteria for complete or partial response after therapy with a regimen containing fludarabine phosphate (FLU) (or another nucleoside analog, e.g. Cladribine \[2-CDA\], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing FLU (or another nucleoside analog); * Failed FLU-CY-Rituximab (FCR) combination chemotherapy at any time point; or * Have "17p deletion" cytogenetic abnormality; patients should have received induction chemotherapy but could be transplanted in 1st CR * Hodgkin Lymphoma must have received and failed frontline therapy * Multiple Myeloma must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted * Acute Myeloid Leukemia (AML) must have \< 5% marrow blasts at the time of transplant * Acute Lymphocytic Leukemia (ALL) must have \< 5% marrow blasts at the time of transplant * Chronic Myeloid Leukemia (CML) patients will be accepted if they are beyond chronic phase (CP)1 and if they have received previous myelosuppressive chemotherapy or HCT and have \< 5% marrow blasts at time of transplant * Myelodysplasia (MDS)/Myeloproliferative Syndrome (MPS) patients must have received previous myelosuppressive chemotherapy or HCT and have \< 5% marrow blasts at time of transplant * Waldenstrom's Macroglobulinemia must have failed 2 courses of therapy * DONOR: FHCRC matching allowed will be Grades 1.0 to 2.1: unrelated donors who are prospectively: * Matched for human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1 by high resolution typing * Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing * DONOR: Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain a panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows \> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion * DONOR: Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\*0101 and the donor is A\*0102, and this type of mismatch is not allowed * DONOR: Only filgrastim (G-CSF) mobilized peripheral blood mononuclear cell (PBMC) only will be permitted as a HSC source on this protocol Exclusion Criteria: * Patients with rapidly progressive intermediate or high grade NHL * Patients with a diagnosis of chronic myelomonocytic leukemia (CMML) * Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy * Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology for patients with AML, MDS, ALL or CML * Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment * Females who are pregnant or breast-feeding * Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years * Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month * Cardiac ejection fraction \< 35%; ejection fraction is required if age \> 50 years or there is a history of anthracycline exposure or history of cardiac disease * Diffusion capacity of carbon monoxide (DLCO) \< 40%, total lung capacity (TLC) \< 40%, forced expiratory volume in one second (FEV1) \< 40% and/or receiving supplementary continuous oxygen * The FHCRC PI of the study must approve of enrollment of all patients with pulmonary nodules * Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bridging fibrosis, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3 mg/dL, or symptomatic biliary disease * Karnofsky score \< 60 or Lansky score \< 50 * Patient has poorly controlled hypertension and on multiple antihypertensives * Human immunodeficiency virus (HIV) positive patients * Active bacterial or fungal infections unresponsive to medical therapy * All patients receiving antifungal therapy voriconazole, posaconazole, or fluconazole and who are then randomized to ARM 3 must have rapamycin reduced according to the Standard Practice of Antifungal Therapy Guidelines * The addition of cytotoxic agents for cytoreduction with the exception of tyrosine kinase inhibitors (such as imatinib), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or Rituxan will not be allowed within three weeks of the initiation of conditioning * DONOR: Donor (or centers) who will exclusively donate marrow * DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for G-CSF mobilization and harvest of G-PBMC
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.
    intervention Names
    1. Drug: Fludarabine Phosphate
    2. Radiation: Total-Body Irradiation
    3. Procedure: Peripheral Blood Stem Cell Transplantation
    4. Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
    5. Drug: Tacrolimus
    6. Drug: Mycophenolate Mofetil
    label
    Arm I (MMF and tacrolimus)
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.
    intervention Names
    1. Drug: Fludarabine Phosphate
    2. Radiation: Total-Body Irradiation
    3. Procedure: Peripheral Blood Stem Cell Transplantation
    4. Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
    5. Drug: Tacrolimus
    6. Drug: Mycophenolate Mofetil
    label
    Arm II (MMF and tacrolimus alternate schedule)
    type
    EXPERIMENTAL
  3. description
    Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.
    intervention Names
    1. Drug: Fludarabine Phosphate
    2. Radiation: Total-Body Irradiation
    3. Procedure: Peripheral Blood Stem Cell Transplantation
    4. Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
    5. Drug: Tacrolimus
    6. Drug: Mycophenolate Mofetil
    7. Drug: Sirolimus
    label
    Arm III (MMF, tacrolimus, and sirolimus)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I (MMF and tacrolimus)
    2. Arm II (MMF and tacrolimus alternate schedule)
    3. Arm III (MMF, tacrolimus, and sirolimus)
    description
    Given IV
    name
    Fludarabine Phosphate
    other Names
    1. 2-F-ara-AMP
    2. Beneflur
    3. SH T 586
    type
    DRUG
  2. arm Group Labels
    1. Arm I (MMF and tacrolimus)
    2. Arm II (MMF and tacrolimus alternate schedule)
    3. Arm III (MMF, tacrolimus, and sirolimus)
    description
    Undergo total-body irradiation
    name
    Total-Body Irradiation
    other Names
    1. TBI
    2. Total Body Irradiation
    3. Whole-Body Irradiation
    type
    RADIATION
  3. arm Group Labels
    1. Arm I (MMF and tacrolimus)
    2. Arm II (MMF and tacrolimus alternate schedule)
    3. Arm III (MMF, tacrolimus, and sirolimus)
    description
    Undergo allogeneic peripheral blood stem cell transplantation
    name
    Peripheral Blood Stem Cell Transplantation
    other Names
    1. PBPC transplantation
    2. Peripheral Blood Progenitor Cell Transplantation
    3. Peripheral Stem Cell Support
    4. Peripheral Stem Cell Transplantation
    type
    PROCEDURE
  4. arm Group Labels
    1. Arm I (MMF and tacrolimus)
    2. Arm II (MMF and tacrolimus alternate schedule)
    3. Arm III (MMF, tacrolimus, and sirolimus)
    description
    Undergo allogeneic peripheral blood stem cell transplantation
    name
    Allogeneic Hematopoietic Stem Cell Transplantation
    other Names
    1. HSC
    2. HSCT
    type
    PROCEDURE
  5. arm Group Labels
    1. Arm I (MMF and tacrolimus)
    2. Arm II (MMF and tacrolimus alternate schedule)
    3. Arm III (MMF, tacrolimus, and sirolimus)
    description
    Given IV or PO
    name
    Tacrolimus
    other Names
    1. Advagraf
    2. FK 506
    type
    DRUG
  6. arm Group Labels
    1. Arm I (MMF and tacrolimus)
    2. Arm II (MMF and tacrolimus alternate schedule)
    3. Arm III (MMF, tacrolimus, and sirolimus)
    description
    Given PO
    name
    Mycophenolate Mofetil
    other Names
    1. Cellcept
    2. MMF
    type
    DRUG
  7. arm Group Labels
    1. Arm III (MMF, tacrolimus, and sirolimus)
    description
    Given PO
    name
    Sirolimus
    other Names
    1. AY 22989
    2. RAPA
    3. SILA 9268A
    4. WY-090217
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
210
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
    measure
    Number of Participants With Grades II-IV Acute GVHD
    time Frame
    150 days after transplant
secondary Outcomes
  1. description
    Percentage of NRM as estimated by cumulative incidence methods with competing risks. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
    measure
    Number of Non-Relapse Mortalities
    time Frame
    200 days after transplant
  2. description
    Number of patients utilizing high-dose corticosteroids (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
    measure
    Number of Participants Utilizing High-Dose Corticosteroids
    time Frame
    150 days after transplant
  3. description
    Number of patients surviving, estimated by cumulative incidence methods Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
    measure
    Number of Participants Surviving Overall
    time Frame
    1 Year post-transplant
  4. description
    Number of patients with progression-free survival, estimated by cumulative incidence methods Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
    measure
    Number of Participants Surviving Without Progression
    time Frame
    2 Years post-transplant
Full study description
brief Summary
This randomized phase II trial studies how well giving tacrolimus and mycophenolate mofetil (MMF) with or without sirolimus works in preventing acute graft-versus-host disease (GVHD) in patients undergoing donor stem cell transplant for hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body-irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system 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 MMF and tacrolimus with or without sirolimus after transplant may stop this from happening.
detailed Description
PRIMARY OBJECTIVES: I. To determine which of 3 GVHD prophylaxis regimens results in reduction of acute grades II-IV GVHD to =\< 40%. SECONDARY OBJECTIVES: I. Reduce the incidence of non-relapse mortality from infections and GVHD before day 200 to =\< 15%. II. Reduce the utilization of high-dose corticosteroids compared to protocols 1463, 1641, and 1668. III. Compare survival and progression-free survival to that achieved under protocols 1463, 1641, and 1668. OUTLINE: CONDITIONING: All patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -4 to -2 and undergo total-body irradiation on day 0. TRANSPLANTATION: All patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive tacrolimus IV or orally (PO) every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. ARM II: Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. ARM III: Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. After completion of study treatment, patients are followed up at 6 months and then every year thereafter.
Source references
references
  1. citation
    Kornblit B, Maloney DG, Storer BE, Maris MB, Vindelov L, Hari P, Langston AA, Pulsipher MA, Bethge WA, Chauncey TR, Lange T, Petersen FB, Hubel K, Woolfrey AE, Flowers ME, Storb R, Sandmaier BM. A randomized phase II trial of tacrolimus, mycophenolate mofetil and sirolimus after non-myeloablative unrelated donor transplantation. Haematologica. 2014 Oct;99(10):1624-31. doi: 10.3324/haematol.2014.108340. Epub 2014 Aug 1.
    pmid
    25085357
    type
    RESULT
  2. citation
    Cooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187.
    pmid
    32499241
    type
    DERIVED
Source notices and limitations
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      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/130/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      76e13d491cbf88a5deebff49fd11f7b3883f1f677ebd88b7f4cd6e89c98f4d0c
    5. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-f9457ebdfaf8302200cf
      requested nct id
      NCT00105001
      primary nct id
      NCT00105001
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      payload sha256
      c3e18dcd9f2cad011d401dccec09d6be8cdacfb7b2cfb94884853ab351be0cf7
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-f9457ebdfaf8302200cf
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00105001
      occurrences
      1. context exact
        NCT00105001
        end
        11
        exact text
        NCT00105001
        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/54/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      76e13d491cbf88a5deebff49fd11f7b3883f1f677ebd88b7f4cd6e89c98f4d0c

    Preserved source evidence · Not medical advice