NCT00782379 · REGISTRY CONDITION SEARCH

Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With 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: 2013-11-21

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and 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 high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.

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

Incidence of Graft Rejection for Patients at Day 100

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outcome · POSTED

Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)

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outcome · POSTED

Overall Survival at Day 100

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outcome · POSTED

Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)

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outcome · POSTED

Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation

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outcome · POSTED

Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)

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outcome · POSTED

Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation

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outcome · POSTED

Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation

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outcome · POSTED

Overall Survival at 12 Months

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outcome · POSTED

Disease Free Survival at 12 Months

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outcome · POSTED

Disease Free Survival at Day 100

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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: DISEASE CHARACTERISTICS: * Diagnosis of one of the following high-risk hematologic malignancies: * Chronic myelogenous leukemia meeting one of the following criteria: * Disease in chronic phase and resistant to available tyrosine kinase inhibitors * Disease in accelerated phase * Disease with blast crisis that has entered into a second chronic phase after induction chemotherapy * Acute myelogenous leukemia meeting the following criteria: * Marrow blasts \< 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH * Must meet one of the following criteria: * Disease in second or subsequent complete remission * Primary induction chemotherapy failure with disease subsequently entering complete remission * Disease in first complete remission with poor-risk cytogenetics or arising from preceding hematological disease * Myelodysplastic syndrome meeting at least one of the following criteria: * Treatment-related * Monosomy 7 or complex cytogenetics * International prognostic scoring system score ≥ 1.5 * Chronic myelomonocytic leukemia * Acute lymphocytic leukemia or lymphoblastic lymphoma meeting the following criteria: * Marrow blasts \< 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH * Must meet one of the following criteria: * Disease in second or subsequent complete remission * Acute lymphocytic leukemia with poor-risk karyotype \[e.g., t(9;22) or bcr-abl fusion, t(4;11), or other MLL translocation\] and in first complete remission * Chronic lymphocytic leukemia or prolymphocytic leukemia meeting both of the following criteria: * Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs * In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy) * Hodgkin or non-Hodgkin lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse disease) meeting the following criteria: * Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation * In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy) NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. * No available matched related or unrelated donor OR a matched related or unrelated donor will not be available in the time frame necessary to perform a transplant * Availability of a first-degree relative (parent, child, sibling) matched at 3/6-5/6 loci (HLA-A, -B, -DR) * Donor must be willing to donate mobilized peripheral blood stem cells * No positive HLA crossmatch in the host-vs-graft direction or high titer donor-specific antibodies PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Bilirubin \< 2 mg/dL (unless due to hemolysis, Gilbert syndrome, or primary malignancy) * Creatinine \< 2 mg/dL OR creatinine clearance ≥ 40 mL/min * Not pregnant * Fertile patients must use effective contraception * LVEF (Left ventriculr ejection fraction) ≥ 45% * FEV\_1 and forced vital capacity ≥ 50% predicted * No HIV positivity * No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No immunosuppressive agents ≤ 24 hours after completion of post-transplant cyclophosphamide (including steroids as antiemetics)
healthy Volunteers: false
maximum Age: 60 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT

Treatment arms and interventions

arm Groups

description
All patients will receive treatment using Fludarabine, Busulfan and Cyclophosphamide prior to receiving a haploidentical transplant followed by post-transplant cyclosphosphamide.
intervention Names
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
label
Myeloablative Haploidentical Transplant
type
EXPERIMENTAL

interventions

arm Group Labels
Myeloablative Haploidentical Transplant
description
110 mg/m2 infused over 3 hours once daily on 4 consecutive days (Days -7, -6, -5, -4)
name
busulfan
type
DRUG
arm Group Labels
Myeloablative Haploidentical Transplant
description
14.5 mg/kg infused over 1-2 hours once daily on 2 consecutive days (days -3,-2).
name
cyclophosphamide
type
DRUG
arm Group Labels
Myeloablative Haploidentical Transplant
description
30mg/m2 infused over 30 minutes once daily on three consecutive days (days -5, -4, -3)
name
fludarabine phosphate
type
DRUG
arm Group Labels
Myeloablative Haploidentical Transplant
description
15 mg/kg po three times a daily with a maximum dose of 3gm/day starting D+5. To be discontinued on Day +35 in the absence of clinically significant GVHD.
name
mycophenolate mofetil
other Names
CellCept
type
DRUG
arm Group Labels
Myeloablative Haploidentical Transplant
description
0.03 mg/kg/day infuse over 24 hours starting on day +5 (adjusted to maintain trough level of 5-15 ng/ml). Switch to oral (twice daily divided dose) on day +21 or when able to tolerate PO. Discontinue on day +180 in the absence of clinically significant GVHD.
name
tacrolimus
other Names
Prograf, FK-506
type
DRUG
arm Group Labels
Myeloablative Haploidentical Transplant
description
Patients to received unmanipulated PBSCs on Day 0
name
allogeneic hematopoietic stem cell transplantation
other Names
Allo HSCT
type
PROCEDURE
arm Group Labels
Myeloablative Haploidentical Transplant
description
patients to receive unmanipulated PBSCs on day 0
name
peripheral blood stem cell transplantation
other Names
allogeneic hematopoietic stem cell transplant
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 20
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Number of patients who experienced graft rejection by Day 100
measure
Incidence of Graft Rejection for Patients at Day 100
time Frame
Day 100
description
Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence
measure
Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)
time Frame
Day 100

secondary Outcomes

description
Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.
measure
Overall Survival at Day 100
time Frame
Day 100
description
Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.
measure
Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)
time Frame
1 year
description
Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
measure
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation
time Frame
Day 30
measure
Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)
time Frame
Day 100
description
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
measure
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation
time Frame
Day 60
description
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
measure
Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation
time Frame
Day 90
description
Overall survival, defined as a patient being alive after transplant, is without regard to disease status.
measure
Overall Survival at 12 Months
time Frame
12 months
description
Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.
measure
Disease Free Survival at 12 Months
time Frame
12 months
description
Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.
measure
Disease Free Survival at Day 100
time Frame
Day 100

Full study description

brief Summary: RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and 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 high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.
detailed Description: OBJECTIVES: Primary * To estimate the incidence of graft rejection and severe graft-versus-host disease after myeloablative HLA-mismatched peripheral blood stem cell transplantation (PBSCT) from first-degree relatives in patients with high-risk hematologic malignancies. Secondary * To estimate overall survival, relapse, non-relapse mortality, and event-free survival in these patients. * To characterize additional hematologic and non-hematologic toxicities of myeloablative haploidentical PBSCT. * To characterize donor hematopoietic chimerism in peripheral blood stem cells after PBSCT. OUTLINE: * Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -2, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV over 1-2 hours on days -3 and -2. * Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo infusion of unmanipulated peripheral blood stem cells on day 0. * Post-transplant regimen: Patients receive high-dose cyclophosphamide IV over 1-2 hours on days 3 and 4, tacrolimus IV over 24 hours or orally twice daily on days 5-180, and oral mycophenolate mofetil 3 times daily on days 5-34 followed by a taper to day 90. Treatment continues in the absence of disease progression or clinically significant graft-vs-host disease. After completion of PBSCT, patients are followed periodically for 1 year.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice