A Phase 2 interventional study of cyclophosphamide and fludarabine phosphate in Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission and Adult Acute Myeloid Leukemia in Remission, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them. Giving cyclophosphamide after transplant may also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening
OBJECTIVES:
I. To determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative bone marrow transplantation (BMT) from human leukocyte antigen (HLA)-haploidentical donors.
OUTLINE:
NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus orally (PO), once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 months and then annually thereafter.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 53 is above the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1. TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35.
Drug: cyclophosphamide · Drug: fludarabine phosphate · Drug: tacrolimus · Drug: mycophenolate mofetil · Genetic: polymerase chain reaction · Genetic: fluorescence in situ hybridization · Genetic: polymorphism analysis · Genetic: gene expression analysis · Radiation: total-body irradiation · Procedure: allogeneic bone marrow transplantation · Procedure: allogeneic hematopoietic stem cell transplantation
Given IV
Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Given IV
Also known as: 2-F-ara-AMP, Beneflur, Fludara
Given IV or orally
Also known as: FK 506, Prograf
Given orally
Also known as: Cellcept, MMF
Correlative studies
Also known as: PCR
Correlative studies
Also known as: fluorescence in situ hybridization (FISH)
Correlative studies
Correlative studies
Undergo total-body irradiation
Also known as: TBI
Undergo haploidentical hematopoietic bone marrow transplantation
Also known as: bone marrow therapy, allogeneic, bone marrow therapy, allogenic, transplantation, allogeneic bone marrow, transplantation, allogenic bone marrow
Undergo haploidentical hematopoietic bone marrow transplantation
Donor Engraftment (Chimerism)
Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population
Time frame: At day +84 after transplantation
Incidence of Grades III-IV Acute GVHD
Grade III GVHD represents moderate severity. Grade IV GVHD represents extreme severity
Time frame: At any time within 200 days after transplantation
Non-relapse-related Mortality
Number of deaths without progression or recurrence of malignant disease
Time frame: Up to 200 days after transplantation
| Milestone | Treatment (Nonmyeloablative HSCT) |
|---|---|
| Started | 55 |
| Completed | 55 |
| Not completed | 0 |
Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population
| Participants | Treatment (Nonmyeloablative HSCT) |
|---|---|
| Donor Engraftment (Chimerism) | 34 |
Grade III GVHD represents moderate severity. Grade IV GVHD represents extreme severity
| Participants | Treatment (Nonmyeloablative HSCT) |
|---|---|
| Incidence of Grades III-IV Acute GVHD | 4 |
Number of deaths without progression or recurrence of malignant disease
| Participants | Treatment (Nonmyeloablative HSCT) |
|---|---|
| Non-relapse-related Mortality | 12 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Nonmyeloablative HSCT) | 30/55 (54.5%) | 11/55 (20%) | 55/55 (100%) |
| Event | Treatment (Nonmyeloablative HSCT) |
|---|---|
| Bacterial infectionInfections and infestations | 7/55 |
| Graft-versus-host diseaseImmune system disorders | 2/55 |
| Secondary myeloid malignancyBlood and lymphatic system disorders | 1/55 |
| Diffuse alveolar hemorrhageRespiratory, thoracic and mediastinal disorders | 1/55 |
| Event | Treatment (Nonmyeloablative HSCT) |
|---|---|
| CMV reactivationInfections and infestations | 27/34 |
| Recurrent or progressive malignancyBlood and lymphatic system disorders | 22/55 |
| Invasive Fungal InfectionInfections and infestations | 6/55 |
| Age, Continuous(years) | Treatment (Nonmyeloablative HSCT) |
|---|---|
| Median | 40 (18 to 73) |
| Sex: Female, Male(Participants) | Treatment (Nonmyeloablative HSCT) |
|---|---|
| Female | 21 |
| Male | 34 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Nonmyeloablative HSCT) |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 49 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Treatment (Nonmyeloablative HSCT) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 41 |
| More than one race | 3 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Treatment (Nonmyeloablative HSCT) |
|---|---|
| United States | 55 |
Plan to share: No — Individual patient data is protected by HIPAA at each participant organization.
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