Phase 2
N=43
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
Accelerated Phase Chronic Myelogenous Leukemia · Adult Acute Lymphoblastic Leukemia in Remission · Adult Acute Megakaryoblastic Leukemia (M7) · Adult Acute Myeloid Leukemia in Remission · Adult Erythroleukemia (M6a)
Bottom Line
View on ClinicalTrials.gov: NCT01427881 ↗Enrolled (actual)
43
Serious AEs
51.2%
Results posted
May 2017
Primary outcome: Primary: Chronic GVHD Requiring Systemic Immunosuppressive Treatment — 16 percent of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cyclophosphamide (Drug); cyclosporine (Drug); peripheral blood stem cell transplantation (Procedure); total-body irradiation (Radiation); fludarabine phosphate (Drug); busulfan (Drug); allogeneic hematopoietic stem cell transplantation (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic GVHD Requiring Systemic Immunosuppressive Treatment |
16 | — |
| SECONDARY Donor Engraftment |
6 | — |
| SECONDARY Grades II-IV and III-IV Acute GVHD |
77; 0 | — |
| SECONDARY Duration of Systemic Immunosuppressive Treatment |
— | — |
| SECONDARY Persistent or Recurrent Malignancy After HCT |
17 | — |
| SECONDARY Non-relapse Mortality |
14 | — |
| SECONDARY Overall Survival |
75.6 | — |
| SECONDARY Disease-free Survival |
73.8 | — |
| SECONDARY Hematologic Recovery |
19; 14 | — |
| SECONDARY Graft Failure |
2 | — |
Summary
This phase II trial studies how well cyclophosphamide works in preventing chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients with hematological malignancies. Giving chemotherapy and total-body irradiation before transplantation helps stop the growth of cancer cells and prevents the patient's immune system from rejecting the donor's stem cells. Healthy stem cells from a donor that are infused into the patient help the patient's bone marrow make blood cells; red blood cells, white blood cells, and platelets. Sometimes, however, the transplanted donor cells can cause an immune response against the body's normal cells, which is called graft-versus-host disease (GVHD). Giving cyclophosphamide after transplant may prevent this from happening or may make chronic GVHD less severe.
Eligibility Criteria
Inclusion Criteria
- Acute lymphocytic leukemia (ALL) in morphologic first complete remission (CR1) with high risk features defined as, but not limited to: evidence of adverse cytogenetics such as t(9;22), t(1;19), t(4;11), or mixed-lineage leukemia (MLL) rearrangements; presence of minimal residual disease; progenitor B-cell immunophenotype; high white blood cells (WBC) at diagnosis (> 30,000/ul in B-ALL; > 100,000/ul in T-ALL); or delayed attainment of CR (> 4 weeks) after induction therapy; additional clinical characteristics deemed to confer a high relapse risk may be discussed with and approved by the Principal Investigator (PI)
- Acute myeloid leukemia (AML) in CR1 EXCEPT patients with low-risk features defined as:
- Inv 16 or t(8;21) in the absence of c-kit mutations
- Normal karyotype who are FLT3-ITD-negative and NPM1-positive in the absence of c-kit mutations
- Patients with respective "low-risk" features are eligible, however, if (i) more than 1 cycle of induction therapy was required to achieve CR1 (ii) the patient had a preceding myelodysplastic syndrome (MDS) other than myelofibrosis, or (iii) secondary AML
- Acute leukemia in 2nd or greater CR (CR >= 2)
- Refractory or relapsed AML with = 2 (Eastern Cooperative Oncology Group [ECOG]) or 60 mL/min, this measurement is acceptable
- Total serum bilirubin more than twice upper normal limit
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3-fold higher than laboratory upper normal limits
- Female patient must have negative serum pregnancy test (all women of child bearing-potential must have test performed)
- DONORS: Potential donors who for psychological, physiological, or medical reasons cannot tolerate administration of G-CSF or apheresis
- DONORS: Donors who are allergic to filgrastim or Escherichia (E.) coli-derived proteins
- DONORS: Donor-related risks to recipients
- DONORS: Positive anti-donor lymphocytotoxic crossmatch
- DONORS: Donors who are positive for HIV
Data sourced from ClinicalTrials.gov (NCT01427881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.