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NCT02556931 · REGISTRY CONDITION SEARCH

Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies

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
2022-11-03

To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell transplant in certain malignancies that are considered difficult to engraft.

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

Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort)

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outcome · POSTED

Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort)

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outcome · POSTED

Number of Participants With Grades III-IV Acute GVHD, Days 90-180 (D90)

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outcome · POSTED

Number of Participants With Grades III-IV Acute GVHD, Days 60-180 (D60)

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outcome · POSTED

Number of Participants With Chronic GVHD, Days 90-180 (D90)

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outcome · POSTED

Number of Participants With Chronic GVHD, Days 60-180 (D60)

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outcome · POSTED

Number of Participants Who Experience Graft Failure, Days 90-180 (D90)

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outcome · POSTED

Number of Participants Who Experience Graft Failure, Days 60-180 (D60)

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outcome · POSTED

Number of Participants Who Experience Disease Relapse, Days 90-180 (D90)

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outcome · POSTED

Number of Participants Who Experience Disease Relapse, Days 60-180 (D60)

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outcome · POSTED

Number of Participants Who Experience Non-relapse Mortality, Days 90-180 (D90)

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outcome · POSTED

Number of Participants Who Experience Non-relapse Mortality, Days 60-180 (D60)

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outcome · POSTED

Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D90)

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outcome · POSTED

Number of Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D60)

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outcome · POSTED

Number of Number of Participants With Severe Chronic GVHD, Day 360 (D90)

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outcome · POSTED

Number of Number of Participants With Severe Chronic GVHD, Day 360 (D60)

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outcome · POSTED

Number of Number of Participants Who Experience Graft Failure, Day 360 (D90)

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outcome · POSTED

Number of Number of Participants Who Experience Graft Failure, Day 360 (D60)

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outcome · POSTED

Number of Participants Who Experience Relapse, Day 360 (D90)

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outcome · POSTED

Number of Participants Who Experience Relapse, Day 360 (D60)

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outcome · POSTED

Number of Participants Who Experience Non-relapse Mortality, Day 360 (D90)

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outcome · POSTED

Number of Participants Who Experience Non-relapse Mortality, Day 360 (D60)

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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: * Presence of a suitable related HLA-haploidentical or -matched stem cell donor, or a 10/10 matched unrelated donor * Eligible diagnoses: myelodysplastic syndrome (MDS) with at least 1 poor-risk feature; small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion or with progression \< 6 months after a second or greater treatment regimen; T-cell prolymphocytic leukemia (PLL) in partial response or better; interferon- or tyrosine-kinase-refractory chronic myeloid leukemia (CML), or CML in second or subsequent chronic phase; Philadelphia chromosome negative (Ph-) myeloproliferative disease, including myelofibrosis; Multiple myeloma or plasma cell leukemia in partial response or better; Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, FISH, flow cytometry, or molecular testing * Any previous autologous transplant must have occurred \> 3 months ago * Left ventricular ejection fraction (LVEF) \>= 35%, or shortening fraction \> 25% * Bilirubin \<= 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis) * AST and ALT \<= 5 x institutional upper limit of normal * FEV1 and FVC \>= 40% of predicted; if unable to perform pulmonary function testing, oxygen saturation \> 92% on room air * ECOG performance status \<= 2, or Karnofsky/Lansky status \>= 60 Exclusion Criteria: * Pregnancy or active breastfeeding * Uncontrolled active infection * Previous allogeneic transplant * Active extramedullary leukemia or active central nervous system (CNS) malignant disease
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status.
    intervention Names
    1. Drug: Fludarabine
    2. Drug: Cyclophosphamide
    3. Radiation: Total body irradiation
    4. Drug: Tacrolimus
    5. Drug: Mycophenolate mofetil
    label
    PBSCT D90
    type
    EXPERIMENTAL
  2. description
    Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status.
    intervention Names
    1. Drug: Fludarabine
    2. Drug: Cyclophosphamide
    3. Radiation: Total body irradiation
    4. Drug: Tacrolimus
    5. Drug: Mycophenolate mofetil
    label
    PBSCT D60
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. PBSCT D60
    2. PBSCT D90
    description
    Days -6 through -2: 30 mg/m\^2 IV daily
    name
    Fludarabine
    other Names
    1. Fludara
    type
    DRUG
  2. arm Group Labels
    1. PBSCT D60
    2. PBSCT D90
    description
    Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily
    name
    Cyclophosphamide
    other Names
    1. Cytoxan
    2. Cy
    3. CTX
    type
    DRUG
  3. arm Group Labels
    1. PBSCT D60
    2. PBSCT D90
    description
    Day -1: 200 cGy in a single fraction
    name
    Total body irradiation
    other Names
    1. TBI
    type
    RADIATION
  4. arm Group Labels
    1. PBSCT D60
    2. PBSCT D90
    description
    Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status.
    name
    Tacrolimus
    other Names
    1. Prograf
    2. FK506
    3. FK-506
    type
    DRUG
  5. arm Group Labels
    1. PBSCT D60
    2. PBSCT D90
    description
    Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
    name
    Mycophenolate mofetil
    other Names
    1. MMF
    2. CellCept
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
117
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 90.
    measure
    Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort)
    time Frame
    Day 90
  2. description
    This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 60.
    measure
    Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort)
    time Frame
    Day 60
secondary Outcomes
  1. description
    Number of participants who experience grade III or IV acute GVHD between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable.
    measure
    Number of Participants With Grades III-IV Acute GVHD, Days 90-180 (D90)
    time Frame
    Between Day 90 and Day 180
  2. description
    Number of participants who experience grade III or IV acute GVHD between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable.
    measure
    Number of Participants With Grades III-IV Acute GVHD, Days 60-180 (D60)
    time Frame
    Between Day 60 and Day 180
  3. description
    Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable.
    measure
    Number of Participants With Chronic GVHD, Days 90-180 (D90)
    time Frame
    Between Day 90 and Day 180
  4. description
    Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable.
    measure
    Number of Participants With Chronic GVHD, Days 60-180 (D60)
    time Frame
    Between Day 60 and Day 180
  5. description
    Number of participants who experience graft failure between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable.
    measure
    Number of Participants Who Experience Graft Failure, Days 90-180 (D90)
    time Frame
    Between Day 90 and Day 180
  6. description
    Number of participants who experience graft failure between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable.
    measure
    Number of Participants Who Experience Graft Failure, Days 60-180 (D60)
    time Frame
    Between Day 60 and Day 180
  7. description
    Number of participants who experience disease relapse between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable.
    measure
    Number of Participants Who Experience Disease Relapse, Days 90-180 (D90)
    time Frame
    Between Day 90 and Day 180
  8. description
    Number of participants who experience disease relapse between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable.
    measure
    Number of Participants Who Experience Disease Relapse, Days 60-180 (D60)
    time Frame
    Between Day 60 and Day 180
  9. description
    Number of participants who die for any reason other than disease relapse between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable.
    measure
    Number of Participants Who Experience Non-relapse Mortality, Days 90-180 (D90)
    time Frame
    Between Day 90 and Day 180
  10. description
    Number of participants who die for any reason other than disease relapse between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable.
    measure
    Number of Participants Who Experience Non-relapse Mortality, Days 60-180 (D60)
    time Frame
    Between Day 60 and Day 180
  11. description
    Number of participants who experience grade III or IV GVHD by Day 360. All participants are evaluable.
    measure
    Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D90)
    time Frame
    Day 360
  12. description
    Number of participants who experience grade III or IV GVHD by Day 360. All participants are evaluable.
    measure
    Number of Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D60)
    time Frame
    Day 360
Full study description
brief Summary
To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell transplant in certain malignancies that are considered difficult to engraft.
detailed Description
The main goal is to learn whether a drug called tacrolimus, which is an immune-lowering drug (an immunosuppressant) given after transplant to help prevent certain complications, can be given safely for a shorter period of time than it has been in the past. The experiences with immunosuppression duration with other allogeneic HSCT platforms cannot be directly extrapolated to the high-dose posttransplantation cyclophosphamide platform (another type of immunosuppressant given after transplant to help prevent GVHD). There are presently no published data on the minimum required duration of tacrolimus after nonmyeloablative HSCT that includes high-dose Cy as part of postgrafting immunosuppression. The effectiveness of high-dose posttransplantation Cy in GVHD prevention, however, permits the investigation of this question. At the present time there are few or no cures for diseases studied on this trial outside of a bone marrow or peripheral blood transplant. The peripheral blood for this transplant comes from a relative who is a half-match or "haplo" match to the participant. Possible donors include parents, siblings, and children. In order to help the bone marrow grow, or "take", inside the body, participants will receive chemotherapy and radiation before the transplant. After the transplant participants will receive high doses of cyclophosphamide (Cytoxan®) along with other medications to lower the immune system, such as tacrolimus. These medications may lower the risk of graft versus host disease (GVHD) and of rejection of the peripheral blood graft.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice