Phase 2 N=77 Treatment

Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders

Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative · Chronic Myelomonocytic Leukemia · de Novo Myelodysplastic Syndrome · Essential Thrombocythemia · Myeloproliferative Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT00397813 ↗

Enrolled (actual)

Serious AEs

20.8%

Results posted

Oct 2018

Primary outcome: Primary: Number of Patients With HCT Failure. — 4; 0; 0; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cyclosporine (Drug); Fludarabine Phosphate (Drug); Laboratory Biomarker Analysis (Other); Mycophenolate Mofetil (Drug); Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation (Procedure); Peripheral Blood Stem Cell Transplantation (Procedure); Total-Body Irradiation (Radiation)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With HCT Failure.	4; 0; 0; 5; 3; 2	—
SECONDARY Number of Patients Who Had Infections	24; 0; 0; 12; 4; 24	—
SECONDARY Number of Patients Who Engrafted	35; 0; 0; 12; 4; 24	—
SECONDARY Number of Patients With Progression-free Survival	24; 0; 0; 1; 2; 11	—
SECONDARY Number of Patients With Relapse/Progression	6; 0; 0; 6; 3; 6	—

Summary

This phase II trial studies the side effects and best dose of total-body irradiation when given together with fludarabine phosphate followed by a donor peripheral stem cell transplant in treating patients with myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD). 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. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune 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 cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

Eligibility Criteria

Inclusion Criteria

Patients aged >= 50 and 50 years or there is a history of anthracycline exposure or history of cardiac disease
Diffusing capacity of the lung for carbon monoxide (DLCO) 3mg/dL, or symptomatic biliary disease
Bone marrow documenting blast count >= 10% or >= 5% in CMML patients who have progressed beyond CMML1 and received myelosuppressive chemotherapy
Patients with active non-hematologic malignancies (except non-melanoma skin cancers); this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy
Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence
Presence of >= 5% circulating leukemic blasts (in the peripheral blood) detected by standard pathology
Active central nervous system (CNS) involvement of disease
Karnofsky performance score 1 month
Active bacterial infection
Patients of fertile age who refuse contraception for a twelve month period post-transplant
Females who are pregnant or breastfeeding
Human immunodeficiency virus (HIV) seropositivity
Severe psychological illness such as major psychosis (e.g. schizophrenia), major bipolar depression, or suicidal situational depression
Matched Related Donor: Identical twin
Matched Related Donor: Any contra-indication to the administration of subcutaneous G-CSF at a dose of 16mg/kg/d for five consecutive days
Matched Related Donor: Serious medical or psychological illness
Matched Related Donor: Pregnant or lactating females
Matched Related Donor: Prior malignancy within the preceding five yrs, with the exception of non-melanoma skin cancers
Matched Related Donor: HIV seropositivity
Unrelated Donor: A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion; 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
Unrelated Donor: Marrow donors
Unrelated Donor: Donors who are HIV-positive and/or medical conditions that would result in increased risk to the donor G-CSF mobilization and G-PBMC collections
Unrelated Donor: Serious medical or psychological illness
Unrelated Donor: Pregnant or lactating females
Unrelated Donor: Prior malignancy within the preceding five yrs, with the exception of non-melanoma skin cancers
Unrelated Donor: HIV seropositivity

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00397813). 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.